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Introduction
prediabetes’, impaired fasting glucose, Prediabetes, HIV and prediabetes, prediabetes, type 2 diabetes, type 2 diabetes mellitus, diabetes
PREDIABETES, IMPAIRED GLUCOSE TOLERANCE, PREDIABETES, TYPE 2 DIABETES, TYPE 2 DIABETES MELLITUS, DIABETES
The rapidly rising prevalence of type 2 diabetes mellitus is a global public health threat. In sub-Saharan Africa (SSA), an estimated 5% of adults are living with type 2 diabetes [Evidence on the efficacy of type 2 diabetes prevention strategies from SSA is scarce. People with blood glucose levels that fall just below ...
PMC10474205
Methods
PMC10474205
Trial design and interventions
prediabetes and HIV
ADVERSE EVENTS, ADVERSE EVENT, EVENTS, ACQUIRED IMMUNODEFICIENCY SYNDROME
The Metformin Treatment for Africa (META) trial was a Phase II randomised placebo-controlled trial conducted among people with prediabetes and HIV who were taking ART. Neither the participants or the healthcare staff or the researchers were aware of participant allocation (i.e. the study was double-blinded). The trial ...
PMC10474205
Interventions
ADVERSE EFFECTS
Participants were asked to take 2000 mg extended-release metformin hydrochloride, dispensed in 500 mg tablets. Placebos were identical in shape, size and appearance. All trial drugs were provided by Merck Healthcare, Darmstadt, Germany. Participants were asked to take four tablets in the evening after food. They were p...
PMC10474205
Randomisation and follow up
Eligible participants were randomised to the intervention arm or control arm using permuted block randomisation with varying block sizes of 4, 6 and 8 people chosen at random using the SAS software (SAS version 9.4, SAS Institute, Cary, NC, USA.). Each participant had a unique randomisation code. The randomisation list...
PMC10474205
Sample size
We had no prior data from SSA. We assumed that the mean (SD) glucose level 2 h following a 75 g oral glucose load would be 10.0 (1.5) mmol/l at 12 months in the placebo arm. We calculated that a study with 160 people per arm would have 85% power to detect a difference in blood glucose levels at 2 h post a 75 g glucose ...
PMC10474205
Trial setting and population
acute metabolic disorders, liver or heart disease, prediabetes
PREDIABETES
The trial was conducted in the HIV clinics of four hospitals in Dar es Salaam, of which three were public hospitals (Amana, Mwananyamala and Temeke Hospitals) and one was a not-for-profit hospital (Shree Hindu Mandal Hospital). These hospitals serve largely urban populations.There is no consensus on how to define predi...
PMC10474205
Blood/urine sampling and data collection
HbAVenous blood samples, diabetes
ADVERSE EVENT, EVENTS, TYPE 2 DIABETES, DIABETES
On arrival at the clinic, a morning blood sample was collected via venepuncture by a research nurse, and fasting blood glucose was measured. Participants were given a 75 g anhydrous glucose solution dissolved in 300 ml non-carbonated water (Rapilose OGTT solution; Galen, Craigavon, UK) and a 2 h post glucose-load capil...
PMC10474205
Timeline and disruption due to the coronavirus disease 2019 pandemic
coronavirus disease 2019
RECRUITMENT, CORONAVIRUS DISEASE 2019, RECRUITMENT
Recruitment began on 4 November 2019 and the last participant was enroled on 21 July 2020. Follow up of participants ended 12 months later, as planned. The first confirmed cases of coronavirus disease 2019 (COVID-19) in Tanzania occurred in mid-March 2020 and caused severe disruption [We maintained the schedule of appo...
PMC10474205
Ethics
The protocol was approved by the LSTM Research ethics committee (reference: 17-078), by the National Institute for Medical Research (NIMR)/Ministry of Health Ethics Committee (reference: NIMR/HQ/R.8a/Vol.IX/2916), by the Tanzania National Research Ethics Committee and by the Tanzania Medicine and Devices Authority. All...
PMC10474205
Statistical methods
fasting blood glucose, diabetes
REGRESSION, EVENTS, SECONDARY, DIABETES
Primary analyses were by intention-to-treat and included participants who were randomised and had at least one valid measurement of primary or secondary outcomes. A linear mixed model was employed for the primary endpoint analysis. The linear mixed model included treatment (metformin vs placebo), visit (midpoint and st...
PMC10474205
Discussion
weight gain, HIV and prediabetes, gestational diabetes, diabetes
GESTATIONAL DIABETES, ADVERSE EVENTS, COMPLICATION, LACTIC ACIDOSIS, TYPE 2 DIABETES, DIABETES
In this Phase II double-blind placebo-controlled trial among people with HIV and prediabetes, there was no significant difference in glucose levels between the metformin and placebo arms at the study end when measured by glucose levels 2 h after a 75 g glucose load or by fasting glucose. However, glucose levels 2 h pos...
PMC10474205
Appendix
PMC10474205
Acknowledgements
We thank staff at Merck, in particular K. Brand (Merck, Darmstadt, Germany), for the supply of products, the Ministry of Health in Tanzania, and T. Chen (LSTM, Liverpool, UK; present affiliation: University of York, York, UK) for support with generation of the participant randomisation list.
PMC10474205
Data availability
The data that support the findings of this study are not openly available due to reasons of sensitivity and are available from the corresponding author upon reasonable request and with the permission of the RESPOND-Africa partnership.
PMC10474205
Funding
DER
This research was funded by the National Institute for Health Research (NIHR; project reference 16/137/87) using UK aid from the UK Government to support global health research. The views expressed in this publication are those of the authors and not necessarily those of the NIHR or the UK Department of Health and Soci...
PMC10474205
Authors’ relationships and activities
The authors declare that there are no relationships or activities that might bias, or be perceived to bias, their work.
PMC10474205
Contribution statement
RS, HL
RECRUITMENT
MJN and KR conceived the idea, and MJN and SJ led the design of the study with input from AG, SK and SM. AG and SK co-ordinated the study, and AG wrote the first draft of the paper with input from SK. KB, DW and HL conducted the statistical analysis. SJ, MJN, KR, UA, AG, SM and KB interpreted the findings. KR was the s...
PMC10474205
References
PMC10474205
1. Introduction
depression, sleep disorders, mood disorders
Emerging science shows that probiotic intake may impact stress and mental health. We investigated the effect of a 6-week intervention with Psychosocial stress is a significant and increasing burden nowadays in our society, is a risk factor for mood disorders including depression and sleep disorders [Dietary interventio...
PMC10383821
2. Materials and Methods
PMC10383821
2.1. Study Design and Population
This randomized, placebo-controlled, 2-arm, parallel, double-blind exploratory clinical trial was conducted in Switzerland between December 2020 and August 2021. Being an exploratory trial, no a priori sample size calculation was performed. Out of a total of 49 eligible volunteers, 47 completed the study (see
PMC10383821
2.2. Intervention
Products were supplied in the form of dry powder contained in aluminum sachets. In alignment with previous preclinical and clinical trials [
PMC10383821
2.3. Procedure
COLD
The experimental procedure comprised two separate testing visits (visit 2: baseline; visit 3: post-intervention) performed at baseline and after 6 weeks starting at 1:00 p.m. following a 24 h abstention from alcohol, coffee (caffeinated or decaffeinated), other caffeinated products, or any other stimulant. Prior to the...
PMC10383821
2.4. Salivary Cortisol
Salivary cortisol awakening response was quantified at baseline and after 6-week supplementation as an index of the hypothalamic–pituitary–adrenal (HPA) axis activity in relation to chronic stress [
PMC10383821
2.5. Autonomic Parameters
SKIN, COLD
Autonomic parameters were collected by means of a portable-computer-based data acquisition system with AcqKnowledge software (BIOPAC Systems Inc., Camino Goleta, CA, USA), using a finger photoplethysmograph and electrodermal activity (EDA) transducers. They were placed on the nondominant hand of the participants. The p...
PMC10383821
2.6. Fecal BL NCC3001 Abundance Analysis
Fecal
PMC10383821
2.7. Statistical Analysis
depression, anxiety
Statistical analyses were conducted on 45 subjects that were randomized to one of the two arms (Psychological endpoints related to acute stress (PANAS, STAI-6, and VAS) and general assessments (PSS-14, HADS, GSRS, and PSQI) were used to assess the effect of the intervention by estimating the treatment difference (probi...
PMC10383821
3. Results
Demographic and clinical characteristics at enrollment were well-balanced across the 45 participants (probiotic
PMC10383821
3.1. Increased Abundance of BL NCC3001 in Stool Shows That the Probiotic Was Successfully Delivered
Supplementation with
PMC10383821
3.2. Probiotic Intervention Reduced Perceived Stress Score
After 6-week intervention with
PMC10383821
3.3. Impact of the Probiotic Intervention on Subjective Reports Independent of Acute Stress
depression, gastrointestinal symptoms, anxiety
At baseline, both the probiotic and placebo groups showed an average score under 8 on both the anxiety (HADS-A) and depression (HADS-D) subscales, with no significant difference between the groups (see Our population showed median, first, and third quartiles scores between 0 and 1 on the PSQI subscales (see To investig...
PMC10383821
3.4. Impact of the Probiotic Intervention on Stress and Autonomic Nervous System Parameters Linked to Acute Stress Response
The salivary cortisol concentration progressively increased up to 20 min following acute stress and then progressively decreased up to the last salivary sample at 40 min post-stressor. The cortisol stress response (AUCg and Cmax) was lower in the probiotic group compared to the placebo group at baseline, and the opposi...
PMC10383821
3.5. Multivariate Analysis Revealed Positive Correlation between Stress Reduction and Reductions in Anxiety and Depression
anxiety
Multivariate analysis revealed a positive correlation between the reduction in perceived stress with the reductions in anxiety (r = 0.32,
PMC10383821
4. Discussion
sleep disturbance, anxiety, pain, depression, stress reduction
This exploratory trial evaluated the effect of Our main findings are in line with a recent meta-analysis assessing the effects of probiotics on stress in healthy subjects, showing that probiotics can reduce the subjective stress level in healthy volunteers without having a significant effect on the cortisol concentrati...
PMC10383821
Supplementary Materials
The following supporting information can be downloaded at Click here for additional data file.
PMC10383821
Author Contributions
Conceptualization, J.H., S.C.M., P.S., G.B. and M.V.; methodology, J.H., C.L., M.V., B.D., K.V. and L.V.O.; formal analysis, L.L., A.R. and N.R.-D.; investigation, C.L., M.S., S.K. and M.V.; data curation, L.L., J.H., N.R.-D., M.B., M.V., B.B., B.D., K.V. and L.V.O.; writing—original draft preparation, M.B., N.R.-D. an...
PMC10383821
Institutional Review Board Statement
The study was conducted in accordance with the Declaration of Helsinki and approved by the Ethics Committee of Canton de Vaud (project ID 2020-00959; approved 26.10.2020) (registered under NCT05226520).
PMC10383821
Informed Consent Statement
Written informed consent was obtained from all subjects involved in the study and was obtained from all subjects involved in the study to publish this paper.
PMC10383821
Conflicts of Interest
C.L.
M.B., N.R.-D., C.L., L.L., S.K., M.S., A.R., B.B., P.S., M.V., G.B., S.C.M. and J.H. are employees of Société des Produits Nestlé S.A., Switzerland. B.D., K.V. and L.V.O. declare that they have no conflict of interest.
PMC10383821
References
Depression, Anxiety
CONSORT flowchart depicting the progression of participants through the study. DASS-42, Depression, Anxiety and Stress Scale; SAF, Safety Analysis Set; FAS, Full Analysis Set.Effects of 6 weeks of intervention with Differential cortisol response at waking and to acute stress: (Impact of the probiotic intervention on su...
PMC10383821
1. Introduction
infection, pulmonary arterial hypertension, coronavirus disease 2019
CORONAVIRUS DISEASE 2019, MUSCLE RELAXATION, INFECTION, PULMONARY ARTERIAL HYPERTENSION, SECONDARY, CORONAVIRUS, SEVERE ACUTE RESPIRATORY SYNDROME
Pulmonary arterial hypertension (PAH) is common in severe coronavirus disease 2019 (COVID-19) and worsens the prognosis. Sildenafil, a phosphodiesterase-5 inhibitor, is approved for PAH treatment but little is known about its efficacy in cases of severe COVID-19 with PAH. This study aimed to investigate the clinical ef...
PMC10223625
2. Materials and Methods
PMC10223625
2.1. Study Setting
SECONDARY, PULMONARY HYPERTENSION
A randomized, double-blind, placebo-controlled, prospective clinical trial was carried out between 9 June 2020 and 12 February 2022 in the intensive care departments of three hospitals in Kyiv, Ukraine: City Clinical Hospital NO. 4, and two multi-profile commercial hospitals, “Manufaktura” and “Raiering”. The study was...
PMC10223625
2.2. Study Population
pulmonary embolism, hypertension, insufficiency, interstitial pneumonia
PULMONARY EMBOLISM, PCT, SARS-COV-2 INFECTION, INTERSTITIAL PNEUMONIA, HYPERTENSION
Adult patients with severe COVID-19 and PAH who met the following inclusion and exclusion criteria were recruited to the study.Inclusion criteria:SARS-CoV-2 infection (confirmed with a positive reverse transcription polymerase chain reaction (RT PCR test));Bilateral interstitial pneumonia confirmed with a computed tomo...
PMC10223625
2.3. Statistical Analysis
MedCalc
PMC10223625
4. Discussion
pulmonary artery hypertension, death
PULMONARY ARTERY HYPERTENSION, VASODILATATION
Our research demonstrated that in patients with severe COVID-19 and pulmonary artery hypertension, treatment with sildenafil resulted in a five times lower risk of death, four times lower risk of intubation with invasive mechanical ventilation, and a shorter ICU hospitalization period by 4 days compared to treatment wi...
PMC10223625
Author Contributions
Conceptualization, O.V.O., W.B. and M.R.; methodology, O.V.O.; software, V.G.G.; formal analysis, O.V.O., W.B., M.R., V.G.G., Y.V.O., O.V.S., S.O.D., O.S.K. and A.Ś.; investigation, O.V.O., Y.V.O., O.V.S., S.O.D., A.Ś. and O.S.K.; data curation, O.V.O. and V.G.G.; writing—original draft preparation, O.V.O. and W.B.; wr...
PMC10223625
Institutional Review Board Statement
The study was conducted according to the guidelines of the Declaration of Helsinki and approved by the Bioethics Committee of the Kyiv City Clinical Hospital No. 4. (Decision No. 1, dated 2 January 2020).
PMC10223625
Informed Consent Statement
Written informed consent was obtained from all subjects involved in the study.
PMC10223625
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 ethical aspects.
PMC10223625
Conflicts of Interest
The authors declare no conflict of interest.
PMC10223625
References
death
REGRESSION
Systolic pulmonary artery pressure before (sPAP1) and after (sPAP2) treatment with sildenafil (S) or the placebo (C), respectively. Solid circles—treatment with sildenafil; empty circles—treatment with placebo. Median, minimum, and maximum values and interquartile ranges are presented.ROC curve predicting risk of death...
PMC10223625
Background
PEx, exhaled breath
LUNG DISEASES
Surfactant phospholipid (PL) composition plays an important role in lung diseases. We compared the PL composition of non-invasively collected exhaled breath particles (PEx) with bronchoalveolar lavage (BAL) and induced sputum (ISP) at baseline and following endotoxin (LPS) challenges.
PMC10623716
Methods
PEx
PEx and BAL were collected from ten healthy nonsmoking participants before and after segmental LPS challenge. Four weeks later, PEx and ISP were sampled in the week before and after a whole lung LPS inhalation challenge. PL composition was analysed using mass spectrometry.
PMC10623716
Results
PEx
The overall PL composition of BAL, ISP and PEx was similar, with PC(32:0) and PC(34:1) representing the largest fractions in all three sample types (baseline PC(32:0) geometric mean mol%: 52.1, 56.9, and 51.7, PC(34:1) mol%: 11.7, 11.9 and 11.4, respectively). Despite this similarity, PEx PL composition was more closel...
PMC10623716
Conclusion
PEx
Our data supports the peripheral origin of PEx. The lack of PL changes in PEx after inhalation challenge might to be due to the overall weaker response of inhaled LPS which primarily affects the larger airways. Compared with BAL, which always contains lining fluid from both peripheral lung and central airways, PEx anal...
PMC10623716
Trial registration
NCT03044327, first posted 07/02/2017.
PMC10623716
Supplementary Information
The online version contains supplementary material available at 10.1186/s12890-023-02718-8.
PMC10623716
Keywords
Open Access funding enabled and organized by Projekt DEAL.
PMC10623716
Background
PEx, exhaled breath
CHRONIC LUNG DISEASE, INFLAMMATORY RESPONSE
Alterations of surfactant phospholipid (PL) composition play an important role in acute and chronic lung diseases [There is currently a broad consent that exhaled breath particles (PEx) are formed when collapsed distal airways (~14So far, nothing is known about the PL composition of PEx at baseline and under inflammato...
PMC10623716
Methods
PMC10623716
Study design
We included ten healthy non-smoking participants (7 male and 3 females, smoking history < 1 pack-year, mean (SD) age 38 ± 10y), with normal lung function (FEV
PMC10623716
Sample collection
FHLC, PEx
IMPACTION
PEx were collected by impaction on polytetrafluoroethylene (PTFE) membranes (FHLC 02500, Merck, Germany) using the PExA® instrument (PExA AB, Sweden). Subjects were asked to perform deep breathing maneuvers to increase the PEx emission [
PMC10623716
Lipid analysis
PEx
PEx samples were extracted from the PTFE membrane using [methanol:dichloromethane:40 mM ammonium acetate(aq)] in the ratios [6:3:2], which was also used as diluent for lipids extracted from BAL and ISP. The latter were extracted using Bligh and Dyer two-phased extraction. The organic phase with lipids was recovered, ev...
PMC10623716
Statistics
Relative quantification was made by expressing the molar amount of each individual lipid as a percentage of the sum of lipids analyzed in the sample. All samples were analyzed in duplicate injections and the average was used. Relative standard deviation for duplicates had an average of 2.4% (range 0–14%) and QC samples...
PMC10623716
Discussion
PEx
DISEASE, INFLAMMATORY RESPONSE, LEAKAGE
Our data demonstrates that, despite an overall similarity, the PL composition of PEx is more closely related to BAL than to ISP, which is in line with the proposed peripheral origin of PEx. PEx analysis was capable to show the inter-individual differences in the level of some lipids that were observed in BAL and ISP. R...
PMC10623716
Limitations
asthma, COPD
COPD, DISEASE, ASTHMA
Due to the complex design and long duration of the study we were only aiming to include 10 participants. Naturally we used BAL to analyse the effects of segmental LPS challenge. Due to ethical reasons, we restricted the analysis of the inhalation challenge to ISP, which due to its more central origin is not directly co...
PMC10623716
Conclusion
PEx
Taken together, this study provides evidence that the PL composition of PEx is more closely related to BAL than to ISP, and that PEx analysis is robust and apparently especially suited to investigate the PL composition in the distal lung.
PMC10623716
Acknowledgements
LUNG
Dr. Anthony Suffredini, NIH Clinical Center, kindly provided Clinical Center Reference Endotoxin. This study was funded by the German Center for Lung Research. We also like to thank the Team of the Fraunhofer ITEM Clinical Airway Research for conducting the study.
PMC10623716
Authors’ contributions
PEx
JMH and OH designed the study. PL, GK, AP were responsible for the lipid analysis, and PL acquired the lipid data. ACO provided the PExA instrument and was a consultant for PEx sampling and analysis. PL and OH performed the data analysis and, together with JMH, outlined the manuscript. ACO, GK and AP participated in th...
PMC10623716
Funding
LUNG
Open Access funding enabled and organized by Projekt DEAL. This study was funded by the German Center for Lung Research, the Swedish Research Council for Health, Working Life and Welfare (FORTE project Nr 2017–02-064), and the European Respiratory Society (ERS) Short-Term Research Fellowship 2017 (project NR STRTF20170...
PMC10623716
Availability of data and materials
The datasets generated and/or analysed during the current study are not publicly available due data protection regulations but are available from the corresponding author on reasonable request.
PMC10623716
Declarations
PMC10623716
Ethics approval and consent to participate
The study was conducted in accordance with local laws, regulations and GCP guidelines (CPMP/ICH/135/95), the protocol was approved by the ethics committee of the Hannover Medical School and registered at Clinicaltrials.gov (NCT03044327, 07/02/2017) and all subjects gave their written informed consent.
PMC10623716
Consent for publication
Not applicable.
PMC10623716
Competing interests
OH, GK, AP and JMH have no competing interest. PL has stocks in PExA AB. ACO is a chairholder of PExA AB.
PMC10623716
References
PMC10623716
Background
shock
CARPAL TUNNEL SYNDROME (CTS), SHOCK
Applying radial extracorporeal shock wave therapy (R-ESWT) with LCI(local corticosteroid injection) in carpal tunnel syndrome (CTS) management is gaining momentum. The objective is to actualize the topic of this study.
PMC10314506
Methods
pain, CTS
In this prospective randomized controlled trial, forty patients with mild to moderate CTS are divided into two sham- R-ESWT and R-ESWT groups subject to LCI(local corticosteroid injection). The first group received four sessions of sham-ESWT weekly, which involved sound but no energy; the second group received R-ESWT a...
PMC10314506
Results
pain
A considerable improvement is observed in both groups for pain at (
PMC10314506
Conclusion
CTS
The R-ESWT + LCI combined therapy course is the first line of treatment in patients with mild to moderate symptoms and leads to control and reduction of symptoms and the need for surgery, thus a primary concern in CTS treatment with an orthopedist.
PMC10314506
Keywords
PMC10314506
Introduction
nerve compression, Edema, tendonitis, CTS, hypothyroidism
SHOCKS, CARPAL TUNNEL SYNDROME, EDEMA, TENDONITIS, FIRES, HYPOTHYROIDISM, PERIPHERAL NEUROPATHY
Carpal tunnel syndrome (CTS), which appears by the pressure exerted on the median nerve in the carpal tunnel, is the most common peripheral neuropathy. Edema, tendonitis, and hormonal changes like hypothyroidism and menopause are involved and manual activity can play a role in increasing nerve compression [Electrohydra...
PMC10314506
Methods and materials
paresthesia, thenar muscle weakness, CTS, infection, dysesthesia, Rheumatoid, Tinel, trauma
SYSTEMIC DISEASE, SCAR, PARESTHESIA, MOTOR NEUROPATHY, INFECTION
This is a prospective clinical trial run from February to August 2020 on 47 patient within the 30 to 60 age range with paresthesia, dysesthesia, and thenar muscle weakness, in Akhtar Hospital (Tehran), who tested positive for Phalen and Tinel test. The tests’ outcomes are confirmed by neurophysiological tests (EMG-NCV)...
PMC10314506
Treatment protocol
paresthesia, numbness, weakness/clumsiness, pain
PARESTHESIA
The triamcinolone acetone (1 ml) + lidocaine (1 ml) is injected into all the patients between the palmaris longus tendon (PL) and the flexor carpi ulnaris tendon (FCU) in the wrist area once [All participants underwent clinical follow-up before beginning the treatment, at the end of the 1st, 3rd, and 6th months for VAS...
PMC10314506
Statistical analysis
pain
The statistical analyses are run in SPSS software (SPSS, Inc., Chicago, IL, USA, Version 16) with a significance level of 5% and a 95% confidence interval. Descriptive data are reported as the mean ± SD. A chi-square test is run for qualitative variables, and a student’s t test is run to compare pain and Global symptom...
PMC10314506
Discussion
CTS, osteoarthritis, inflammation
OSTEOARTHRITIS, DISEASES, INFLAMMATION
ESWT is a new noninvasive procedure applied extensively in recent years in treating soft tissue diseases like osteoarthritis [In many studies, nitric oxide produced by ESWT contributes to an increase in the angiogenesis growth factors’ level and inhibits inflammation through the suppressive production of pro-inflammato...
PMC10314506
Author contributions
MG and RM offer main title, and SB and MG prepared figures. MG and RM wrote the main manuscript text. All authors reviewed the manuscript.
PMC10314506
Funding
No funding.
PMC10314506
Availability of data and materials
Not applicable.
PMC10314506
Declarations
PMC10314506
Ethical approval and consent to participate
The Ethics Committee of Shahid Beheshti University of Medical Sciences regulations, which are explained to the participants [IR.SBMU.RETECH.REC.1399.1150].
PMC10314506
Competing interests
The authors declare that they have no competing interests.
PMC10314506
References
PMC10314506
1. Background
obesity, cardiometabolic and cognitive health outcomes [, cardiovascular disease, diabetes [A
OBESITY, CARDIOVASCULAR DISEASE, CVD, METABOLIC DISEASES, METABOLIC SYNDROME, DYSLIPIDEMIA
These authors contributed equally to this work.The impact of a Mediterranean diet on the intestinal microbiome has been linked to its health benefits. We aim to evaluate the effects of a Mediterranean diet supplemented with dairy foods on the gut microbiome in Australians at risk of cardiovascular disease. In a randomi...
PMC10459086
2. Materials and Methods
PMC10459086
2.1. Study Overview
CVD
CVD, CARDIOVASCULAR DISEASE
A randomised controlled trial with a 2 × 2 cross-over design was used to compare a Mediterranean diet supplemented with adequate dairy foods (MedDairy or MD) against a low-fat (LFD) control diet in individuals at risk of cardiovascular disease (CVD) (study protocol has been described previously [
PMC10459086
2.2. Participants
elevated systolic blood pressure, hypertensive, CVD
CVD, CARDIOVASCULAR DISEASE
The MedDairy study recruited adults with a risk of cardiovascular disease (CVD). Inclusion criteria were age between 45 and 75 years, an elevated systolic blood pressure (SBP) of ≥120 mmHg, not on hypertensive medication, and a diagnosis of at least two of the following: overweight/obesity (body mass index, BMI ≥ 25 kg...
PMC10459086
2.3. Study Intervention
Participants followed a MedDairy or LFD diet intervention for 8 weeks, separated by an 8-week washout phase where participants returned to their habitual diet. Participants were stratified by gender and age and randomly assigned to their first dietary phase (MedDairy or LFD) by a blinded independent staff member. Instr...
PMC10459086