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INTRODUCTION | gastrointestinal cancer | RECTAL ADENOCARCINOMA, GASTROINTESTINAL CANCER | Great progress in technique and device development has been made in endoscopic resection of early-stage gastrointestinal cancer with endoscopic mucosal resection and endoscopic submucosal dissection (ESD) (The synthetic self-assembling peptide, TDM-621 (3-D Matrix, Tokyo, Japan), is derived from nonliving sources and c... | PMC9889198 |
METHODS | This multicenter, randomized, open-label, parallel-group comparative trial was conducted from August 2017 to August 2019 with the approval of the Institutional Review Board of each facility in compliance with relevant laws and regulations, including the Declaration of Helsinki and the Japanese Ministerial Ordinance on ... | PMC9889198 | ||
Patients | gastric/colorectal cancer, cancer, hypersensitivity, blood coagulation | INFLAMMATORY BOWEL DISEASE, CARCINOMA OF THE STOMACH, CANCER, ULCERATION, HYPERSENSITIVITY | Patients for whom ESD was indicated (following the Japanese gastric/colorectal cancer treatment guidelines and the gastric/colorectal ESD/endoscopic mucosal resection guidelines) (The exclusion criteria were as follows: residual or local recurrent lesions, ulceration of the target lesions, poorly differentiated adenoca... | PMC9889198 |
Study protocol | JET | ESD-trained endoscopists who had performed more than 20 ESD procedures participated in the study (In the TDM-621 group, hemostasis was performed using TDM-621, and coagulation hemostasis was performed using hemostatic forceps (Coagrasper, Olympus, Tokyo, Japan) if hemostasis was not achieved within 3 minutes. TDM-621 w... | PMC9889198 | |
Outcome measurements | bleeding | SECONDARY, EVENT, BLEEDING | The primary efficacy end point was the mean number of coagulations (performed with hemostatic forceps), as determined by the third-party evaluation committee.The secondary efficacy end points were the mean number of coagulations (determined by the operator), time from confirmation of a blood oozing event to the complet... | PMC9889198 |
Safety evaluation | ADVERSE REACTIONS, POSTOPERATIVE BLEEDING | The incidence of defects derived from TDM-621 treatment and AE (including abnormalities in clinical test values, postoperative bleeding for 7 and 28 days after ESD, and adverse reactions) were assessed for the evaluation of safety. | PMC9889198 | |
Sample size and statistical analysis | SECONDARY, ADVERSE REACTIONS | The mean number of coagulations during ESD with hemostatic forceps (the primary efficacy end point) was assumed to be 3.1 in the control group and 2.1 in the TDM-621 group, based on our pilot study. Based on this assumed mean value, simulated data were created using random numbers according to a Poisson distribution. T... | PMC9889198 | |
RESULTS | PMC9889198 | |||
Composition of patients | bleeding | BLEEDING | A total of 227 patients were enrolled from the 7 facilities and randomized (TDM-621 group, 112; control group, 115). Of them, 33 in both groups were excluded because of good clinical practice deviation, unavailability of record video, and misinclusion of bleeding in which bleeding source was identifiable after a single... | PMC9889198 |
Demographic and other baseline characteristics | Table Baseline demographic and clinical characteristics of the patients (PPS) | PMC9889198 | ||
Primary and secondary efficacy end points | SECONDARY | The mean number of coagulations (the primary efficacy end point) determined by the third-party evaluation committee was significantly higher in the control group (4.9 ± 5.2) than in the TDM-621 group (1.0 ± 1.4) (Effect of TDM-621 on the number of cauterizations with hemostats (PPS). Data are provided as mean ± SD. *Ot... | PMC9889198 | |
Other end points | tumors | TUMORS | The amount of TDM-621 applied was 1.75 ± 2.14 mL according to the operator's determination, and the operability was evaluated as “appropriately applied to the target site” in 85 patients (98.8%), all but 1. All targeted tumors were successfully removed | PMC9889198 |
Safety results | post-ESD coagulation syndrome, fever, abdominal pain | ADVERSE REACTIONS, INFLAMMATION, ADVERSE EVENTS | The AE incidence rate was 39.6% in the TDM-621 group and 37.6% in the control group, with no significant differences between the groups. The incidence rate of adverse reactions was 1.0% in the TDM-621 group, and no adverse reactions were observed in the control group. No defects derived from TDM-621 occurred in any pat... | PMC9889198 |
DISCUSSION | blood spurting, bleeding, death, blood oozing | SECONDARY, RECTAL TUMORS, BLEEDING | This study showed that TDM-621 is a useful hemostatic peptide for blood oozing during ESD for gastric or rectal tumors and that severe AE do not occur with this peptide solution.This is the first multicenter, randomized, parallel-group comparative study to directly compare the efficacy and safety of TDM-621 with those ... | PMC9889198 |
Supplementary Material | PMC9889198 | |||
Study Highlights | PMC9889198 | |||
WHAT IS KNOWN | tumor, intraoperative bleeding | TUMOR, INTRAOPERATIVE BLEEDING |
✓ Intraoperative bleeding occurs commonly with tumor resection, especially during rectal and gastric endoscopic submucosal dissection (ESD).✓ Management of intraoperative bleeding with hemostatic forceps is crucial to the success of ESD.✓ TDM-621, a synthetic, self-assembling peptide derived from nonliving sources, ma... | PMC9889198 |
WHAT IS NEW HERE |
✓ The number of coagulations with hemostatic forceps was significantly reduced in those who received TDM-621 in this trial.✓ Hemostasis was achieved with TDM-621 alone in 62% of patients. | PMC9889198 | ||
REFERENCES | PMC9889198 | |||
1. Introduction | TNF-α, Psoriasis, hyperplasia, hereditary predisposition, Tumor necrosis, psoriasis | INFILTRATION, PSORIASIS, HYPERPLASIA, PROLIFERATION, INFLAMMATION, INFILTRATES, PSORIASIS, TUMOR NECROSIS, INFLAMMATORY SKIN DISEASE, PATHOGENESIS | These authors contributed equally to this work.Psoriasis is a chronic inflammatory skin disease with autoimmune pathological characteristics. Recent research has found a link between psoriasis, inflammation, and gut microbiota dysbiosis, and that probiotics and prebiotics provide benefits to patients. This 12-week open... | PMC10342574 |
2. Results and Discussion | PMC10342574 | |||
2.2. PASI, DLQI, and Anthropometric Measures | FM | As presented in Although we observed no significant difference between the two groups in terms of fat mass (FM) changes ( | PMC10342574 | |
2.3. Inflammatory Markers | psoriasis | PSORIASIS | The effects of probiotic and prebiotic supplementation on inflammatory markers are presented in The association between probiotic supplementation in patients with psoriasis and changes in inflammatory markers is yet an active research field, but preliminary findings have revealed promising effects [ | PMC10342574 |
2.4. Metabolic Parameters | metabolic syndrome, low-density lipoprotein (LDL)-C | METABOLIC SYNDROME | After adjusting the cholesterol level results for sex, age, and baseline values, our results showed a significant difference between groups in total cholesterol (C), low-density lipoprotein (LDL)-C, and high-density lipoprotein (HDL)-C (Our study demonstrated that probiotic and prebiotic supplementation for 12 weeks re... | PMC10342574 |
2.5. Ultrasound Assessments | psoriasis | PLAQUE, PSORIASIS | Using the data generated from the high-frequency ultrasonography of psoriatic skin, we found significant differences in psoriasis plaque hydration, perilesional area hydration, and subepidermal low-echogenic band (SLEB) between the two groups ( | PMC10342574 |
2.6. Gut Microbiota Changes | psoriasis | PSORIASIS | After 12 weeks of probiotic and prebiotic supplementation, we identified 12 markers that differed significantly from baseline, including changes in seven bacterial abundances (The Shannon index is a parameter used to assess gut microbiota bacterial diversity, with higher values signifying greater community diversity [B... | PMC10342574 |
2.7. Limitations | This study had several limitations that should be considered when interpreting the results. First, due to the relatively small sample size ( | PMC10342574 | ||
3. Materials and Methods | PMC10342574 | |||
3.1. Ethical Considerations | This study was conducted according to the guidelines outlined in the Declaration of Helsinki, the Amsterdam Protocol, and Directive 86/609/EEC. The study protocol was approved by the Ethical Commission of the “Iuliu Haţieganu” University of Medicine and Pharmacy Cluj-Napoca (No. 267/06.30.2021). Prior to enrollment, al... | PMC10342574 | ||
3.3. Data Collection | psoriasis | BLOOD, PSORIASIS | Background demographic and psoriasis diagnosis data were collected at the screening visit. Blood was collected at the beginning (screening visit) and end (Week 12) of the study. Levels of serum TNF-α, IL-6, IFN-γ, IL-17A, IL-10, and insulin were determined using commercially available enzyme-linked immunosorbent assay ... | PMC10342574 |
3.4. Statistical Analysis | For normally distributed data, the mean and SD are reported; median and IQR are reported for non-normally distributed data. The paired-samples t-test and related-samples Wilcoxon signed rank test were used to detect differences among patients within the same group (i.e., from baseline to Week 12). Data from the interve... | PMC10342574 | ||
4. Conclusions | psoriasis | INFLAMMATION, PSORIASIS | According to our findings, probiotic and prebiotic supplementation enhanced the general health of patients with psoriasis who were receiving local anti-psoriatic treatment. First, probiotic and prebiotic supplementation significantly improved quality of life, as demonstrated by a reduction in PASI and DLQI scores. Seco... | PMC10342574 |
Author Contributions | Conceptualization, M.C.B., R.C., D.M., A.B. and A.C.; methodology, M.C.B., L.I.G. and A.B.; supervision, L.I.G., D.M. and A.C.; writing—original draft, M.C.B. and R.C.; writing—review and editing, L.I.G. and A.T. All authors have read and agreed to the published version of the manuscript. | PMC10342574 | ||
Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki and approved by the Ethics Committee of the “Iuliu Haţieganu” University of Medicine and Pharmacy Cluj-Napoca (No. 267/06.30.2021). | PMC10342574 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10342574 | ||
Data Availability Statement | The data presented in this study are available on request from the corresponding author. The data are not publicly available due to privacy and ethical considerations. | PMC10342574 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC10342574 | ||
References | tumor necrosis | TUMOR NECROSIS | Abundances that showed a significant difference (Design and flow of the study.Background characteristics.* Pearson’s chi-square test. ** Independent-samples DLQI and PASI comparison between the intervention and control groups.* Paired-samples Anthropometric data comparison between the intervention and control groups.* ... | PMC10342574 |
Subject terms | SCES, cord injury, torques | SECONDARY | Two persons with chronic motor complete spinal cord injury (SCI) were implanted with percutaneous spinal cord epidural stimulation (SCES) leads to enable motor control below the injury level (NCT04782947). Through a period of temporary followed by permanent SCES implantation, spinal mapping was conducted primarily to o... | PMC10091329 |
Introduction | SCES, cord injury | SPINAL CORD | Spinal cord epidural stimulation (SCES) may modulate spinal cord neural networks to enhance multiple functions after motor complete spinal cord injury (SCI)This case report describes early results of two persons with clinically sensory-motor complete and a motor complete SCI enrolled in a clinical trial investigating t... | PMC10091329 |
Study timeline. | SCES, EAW | Timeline of study phases for NCT04782947. After baseline outcome measures are assessed, temporary implantation occurs followed by 5 days of mapping. After removal of the temporary implant, participants are given 2 weeks rest and then receive the permanent implant. Permanent implant mapping occurs for 2 weeks, focusing ... | PMC10091329 | |
Results | PMC10091329 | |||
Participant characteristics | Spinal Injury Association Impairment Scale [, traumatic SCI | Two men with clinically motor complete traumatic SCI (C8; 6 years post-injury [ID#: 0772] and T11; 9 years post-injury [ID#: 0773]), American Spinal Injury Association Impairment Scale [AIS] A and B, respectively) participated in a trial approved by the Hunter Holmes McGuire Veteran Affairs Medical Center ethical IRB c... | PMC10091329 | |
Temporary and permanent implantation | SCES | Both participants underwent temporary SCES implantation (5 days) followed by permanent implantation 4 weeks later (Supplementary Figs. | PMC10091329 | |
Spinal mapping | Spinal mapping was carried out to identify optimal configurations (cathodal-anodal electrode arrangements and stimulation parameters) to enable multiple functions and movements without inducing unwanted activity | PMC10091329 | ||
Supine rhythmic EMGs. | SCES | Example electromyograms (EMGs) of left leg muscles (black traces) and right leg muscles (gray traces) while SCES is delivered in supine at various amplitudes to participant 0773, using the configuration shown on the left of the figure (black is the cathode and the red is the anode). In the left column of EMGs, SCES del... | PMC10091329 | |
Voluntary motor activity | SCES, voluntary movements | Participant 0772 did not elicit intentional voluntary movements in supine or side lying positions. His legs moved in response to different SCES configurations following temporary implantation. On day 1 of temporary mapping, in the presence of percutaneous SCES, 0773 voluntarily flexed his right hip from a side lying po... | PMC10091329 | |
Configuration for 0773 resulting in right leg flexion. | knee extension | Left leg muscles are depicted in black and right leg muscles in gray. Both plots occurred simultaneously but have been separated to better visualize different effects of voluntary effort between legs. At 1.3 mA, bilateral muscle activity was induced. However, when the participant volitionally attempted to flex his righ... | PMC10091329 | |
Standing ability | SCES | In the first phase of the study, with SCES on, 0772 did not need to use his upper extremities for balance self-assistance in a standing position. In contrast when SCES was off, he needed to hold the parallel bars and use his upper extremities to self-assist balance. However, 0772 required maximal knee assistance and mo... | PMC10091329 | |
Voluntary hip flexion and extension with trunk control (participant 0772) from a semi-standing position in a standing frame. | Panels | PMC10091329 | ||
0772 Exoskeleton sit-to-stands. | Electromyograms (EMGs) of lower extremity muscles of 0772 during active attempts to complete a sit-to-stand maneuver with the exoskeleton in “Squat” mode. In this mode, the exoskeleton will not passively complete a sit-to-stand for the user; rather, assistive torque is provided at the knees and hips which can enable th... | PMC10091329 | ||
0773 overground standing. | Electromyograms (EMGs) of lower extremity muscles of 0773 during overground standing in parallel bars. | PMC10091329 | ||
Exoskeleton-assisted walking and overground stepping | Using the aforementioned mapping procedures in the interim period, configurations for rhythmic activity did not yield locomotor-like muscle activity in supine position in that the bursting was synchronous across all muscles in both legs (i.e. lack of a reciprocal relationship between antagonistic muscles or left-right ... | PMC10091329 | ||
EAW enhancement figure. | EAW | Data points showing changes in exoskeleton-assisted walking (EAW) performance for two participants walking in “Adaptive” mode, a manufacturer setting which adjusts the amount of assistance provided to the user, and thus can result in variability in certain parameters of gait. | PMC10091329 | |
EAW enhancement EMG figure. | SCES, EAW | Example electromyograms of one participant (0773) during exoskeleton-assisted walking (EAW) without or with spinal cord epidural stimulation (SCES). Left leg muscles are shown in black, right leg muscles are shown in gray. Without SCES, very little muscle activity occurs through the gait cycle, mainly in the right hams... | PMC10091329 | |
Discussion | muscle mass, exoskeleton-provided, reduced exoskeleton-provided, flexion or extension torques, knee flexion, hip flexion, SCES, chronic motor complete SCI | Percutaneous SCES enabled motor control in two persons with chronic motor complete SCI. Both participants could also volitionally modulate induced flexion or extension torques on verbal instruction in a seated position. One participant (0773) initiated hip flexion, knee flexion, and ankle dorsiflexion in a supine lying... | PMC10091329 | |
Methods | PMC10091329 | |||
Subjects | Spinal Injury Association Impairment Scale [, traumatic SCI | Two men with clinically motor complete traumatic SCI (C8; 6 years post-injury [ID#: 0772] and T11; 9 years post-injury [ID#: 0773]), American Spinal Injury Association Impairment Scale [AIS] A and B, respectively) participated in a trial approved by the Hunter Holmes McGuire Veteran Affairs Medical Center ethical IRB c... | PMC10091329 | |
Inclusion and exclusion criteria | flexion knee contractures, neurological injury, traumatic motor complete SCI, scoliosis, areflexia, fracture, contracture, −3.5, ’ knee extensors, cardiovascular problems, Spinal Injury, cauda equina | UNCONTROLLED HYPERTENSION, TYPE II DIABETES MELLITUS, CARDIOVASCULAR DISEASE, SCOLIOSIS, ORTHOSTATIC HYPOTENSION, URINARY TRACT INFECTION | Participants may be included if they are between 18 and 60 years old, male or female, with traumatic motor complete SCI and level of injury of between C5 to T10, as determined the International Standards for Neurological Classification of SCI (ISNCSCI) exam. Participants’ knee extensors must respond to standard surface... | PMC10091329 |
Magnetic resonance imaging | Prior to enrollment in the trial, participants were asked to conduct magnetic resonance image (MRI; T2 Turbo Spin Echo with long band width; SIEMENS 1.5T) with the following scanning sequence (slice thickness: 3 mm, TR: 9350, TE: 102; flip angle: 150) for pre-screening purpose. MRI was conducted to verify the injury si... | PMC10091329 | ||
Interventions | PMC10091329 | |||
Implantation of epidural stimulation | SCES, pain | EVENTS, ENLARGEMENT | This is a 2-step process where temporary implantation precedes permanent implantation when indicated. The SCES system (Intellis Epidural Stimulator, Medtronic, Minneapolis, USA) was used to electrically stimulate the lumbosacral enlargement. During temporary implantation, two 8-electrode lead arrays were implanted util... | PMC10091329 |
Temporary implantation | MINOR | Participants were scheduled to perform the temporary implantation. After placing the participant in a prone position, the participant was implanted in a minor procedure room under fluoroscopy guidance. A nurse certified in sedation established IV access, place standard ASA monitors including noninvasive blood pressure ... | PMC10091329 | |
Permanent implantation | pain | STERILE | Fourteen days following temporary implantation, two 8-electrode arrays of Vectris lead were implanted in an operating room (see the listed details about the Intellis System). The trial was undertaken in a sterile environment with the presence of a representative. Phase 1 of the permanent implantation is identical to th... | PMC10091329 |
The Intellis system has two main sets of components | fits, ® | STERILE, PAD |
External components for IntellisModel 97715/97716 Wireless External NeurostimulatorThe Medtronic Model 97715/97716 Wireless External Neurostimulator (ENS) is part of a neurostimulator system used for intraoperative testing during lead placement and for trial stimulation outside of the operating room. The Medtronic Mod... | PMC10091329 |
Spinal segmental mapping | SCES, lower extremity muscle | RECRUITMENT, CONTRACTION, RECRUITMENT | Following both temporary and permanent implantation, participants were scheduled to perform the process of spinal segmental mapping. Spinal mapping is the process of identifying the right stimulation parameters (frequency, amplitude, and pulse duration) responsible for activation of the lower extremity muscle groups, p... | PMC10091329 |
Exoskeleton assisted walking | AUTONOMIC DYSREFLEXIA | Prior to training, a research assistant helped to fit the participant into the device starting with the shoes-support (distally) and then going up toward the trunk (proximally). The software was adjusted and progressed based on the need of each participant. Every effort was made to ensure that all straps were snug but ... | PMC10091329 | |
Progression to the adaptability mode | EAW | This mode allows the exoskeleton to gradually lower the assistance provided to the participant based on their performance. In the adaptive assistance mode, the support ranges from 0 to 100%, with 100% means that the unit provides 100% support and assistance to ambulate. During sessions, SCES was turned on and we starte... | PMC10091329 | |
Overground standing and ambulation without exoskeleton | Following the exoskeleton session, a follow-up-visit on the same day was conducted to provide over ground standing and walking experience. This started by allowing the subject to stand-up in a standing frame or between parallel bars and to do stepping for 10 feet assisted by a trained researcher. If the subject manages... | PMC10091329 | ||
Measurements | PMC10091329 | |||
Surface EMGs | After standard skin preparation, surface EMGs were used to record lower extremity and/or trunk muscles, depending on the task being tested. Muscles assessed for mapping and voluntary movement testing included bilateral vastus medialis, rectus femoris, tibialis anterior, hamstring, medial gastrocnemius, and gluteus medi... | PMC10091329 | ||
Exoskeleton-assisted walking performance | Exoskeleton-assisted walking performance variables - steps per minute, step length, and minimum assistance – are derived from data collected by the exoskeleton itself, and then automatically uploaded to the company’s online clinical database. Step length and minimum assistance are provided for each individual leg, wher... | PMC10091329 | ||
Overground ambulation | During post-interventions 1 and 2, overground ambulation without wearing the exoskeleton was tested using parallel bars over a 10-feet (3.05 m) walking distance. | PMC10091329 | ||
Peak isometric torque | SCES | This was evaluated using a Biodex isokinetic dynamometer (Shirely, NY). Participants were seated with both the trunk-thigh angle and the knee-thigh angle at 90°. After transferring using a ceiling lift, each participant was securely strapped to the test chair by a crossover shoulder harnesses and a belt across the hip ... | PMC10091329 | |
Reporting summary | Further information on research design is available in the | PMC10091329 | ||
Supplementary information |
Supplementary InformationPeer Review FileReporting Summary | PMC10091329 | ||
Supplementary information | The online version contains supplementary material available at 10.1038/s41467-023-37845-7. | PMC10091329 | ||
Acknowledgements | DoD-CDMRP | The work is currently supported by the DoD-CDMRP clinical trial program award number # W81XWH-20-1-0845 (SC190107 CDMRP W91ZSQ) and Department of Veteran Affairs-SPiRE Program (B3456-P). We would like to thank Center for Rehabilitation Science Engineering Centre-VCU (Ronald Seel, PhD & David Cifu, MD) for providing sci... | PMC10091329 | |
Author contributions | SCES, T.D.L. | A.S.G., D.L., and R.T initiated the project and designed the study protocol. L.L.G. and T.D.L. performed clinical assessments. R.T. Intraoperative placement of the SCES and subjects’ assessment. A.S.G., T.W.S., J.A.G., and A.A. contributed to data collection, analysis, and interpretation and drafted the manuscript with... | PMC10091329 | |
Peer review | PMC10091329 | |||
Data availability | De-identified data of the two participants will be available upon direct communication with the corresponding author and upon receiving approval from the appropriate research committee from the Department of Veteran Affairs immediately following publication and available for 3 years. Source data, study protocol and inf... | PMC10091329 | ||
Competing interests | The authors declare no competing interests. | PMC10091329 | ||
References | PMC10091329 | |||
Key Points | PMC9857469 | |||
Question | CVD | CVD, CARDIOVASCULAR DISEASE | What are the impacts of an entirely plant-based vs a low-fat, reduced–animal product omnivorous diet on changes in 12-month and 24-month body weight and lipids among African American adults at risk for cardiovascular disease (CVD)? | PMC9857469 |
Findings | CVD | In this randomized clinical trial of 159 adults, participants in both groups saw similar improvements in body weight and CVD risk factor outcomes. | PMC9857469 | |
Meaning | weight loss | CVD | Both plant-based and low-fat omnivorous soul food diets produced modest weight loss and CVD risk-related improvements among African American adults.This randomized clinical trial compares the effects of an entirely plant-based vegan or low-fat omnivorous diet on change in body weight and lipids during a 2-year interven... | PMC9857469 |
Importance | CVD, chronic disease | CVD, CARDIOVASCULAR DISEASE, CHRONIC DISEASE | More African American individuals die from cardiovascular disease (CVD) than any other chronic disease condition. Despite this disparity, African American individuals are underrepresented in nutrition and CVD interventions. | PMC9857469 |
Objective | To compare the effects of an entirely plant-based (vegan) or low-fat omnivorous (omni) diet on change in body weight and lipids during a 2-year intervention. | PMC9857469 | ||
Design, Setting, and Participants | weight loss, overweight or obesity | TYPE 2 DIABETES, THYROID DISEASE | The Nutritious Eating With Soul (NEW Soul) study was a 2-year, randomized clinical trial conducted in 2 cohorts (2018-2020 and 2019-2021) that took place in a university teaching kitchen in Columbia, South Carolina (before March 2020), and via online videoconference sessions (after March 2020). Participants included Af... | PMC9857469 |
Interventions | The intervention included weekly nutrition classes for 6 months biweekly classes for 6 months, and monthly classes for 12 months. Dietary interventions either emphasized no animal product intake (vegan) or a low-fat omnivorous diet (omni). Both dietary patterns emphasized soul food cuisine (traditional African American... | PMC9857469 | ||
Main Outcomes and Measures | Primary outcomes included change in body weight and lipid measures at 12 months. | PMC9857469 | ||
Results | There were 568 participants who completed an online screening questionnaire; 409 were excluded and 159 were randomized (77 to the vegan group and 82 to the omni group). Of the 159 participants (mean [SD] age, 48.4 [10.6] years; 126 female [79%]) who began the study, the main outcome of body weight was obtained for 121 ... | PMC9857469 | ||
Conclusions and Relevance | weight loss | CVD | In this randomized clinical trial examining weight loss and CVD risk factor reduction among African American adults, there were no differences between the groups, and the magnitude of changes overall was small. | PMC9857469 |
Trial Registration | ClinicalTrials.gov Identifier: | PMC9857469 | ||
Introduction | overweight or obesity, CVD | CVD, CARDIOVASCULAR DISEASE, CHRONIC DISEASE | In the US, African American individuals die from cardiovascular disease (CVD) more than any other chronic disease.Although several studiesThe Nutritious Eating With Soul (NEW Soul) study, a 2-year behavioral nutrition intervention among African American individuals with overweight or obesity, was conducted to address t... | PMC9857469 |
Methods | PMC9857469 | |||
Study Participants | The NEW Soul intervention, inclusion criteria, and measures have been described elsewhere. | PMC9857469 | ||
Measures | Measures for the NEW Soul intervention have been described elsewhere. | PMC9857469 | ||
Measures Assessed and the Time Points in the Nutritious Eating With Soul Study | PMC9857469 |
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