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Effects of Green-MED Diet Via the Gut-fat-brain Axis

NCT03020186 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 294

Last updated 2019-07-15

No results posted yet for this study

Summary

Mediterranean (MED) diet, richer in plants/seeds (and dietary polyphenols) and low in processed meat (green-MED diet) may have a pronounced beneficial effect on age-related declines that begin in middle age, reflected by changes in adiposity, cognitive function, and cardiometabolic risk. The investigators hypothesize that long-term intake of this diet will significantly potentiate the effects of a healthy lifestyle (physical activity and Mediterranean diet), constituting a powerful strategy to halt or even reverse the progression of several age-related processes related to adiposity, cardiometabolic health and cognition. The investigators further hypothesize that lifestyle intervention might modify the gut microbiota profile and that autologous fecal microbiota supplement derived from the time of maximal weight loss might halt the expected subsequent regain phase.

Conditions

  • Abdominal Obesity Metabolic Syndrome

Interventions

OTHER

Physical activity

OTHER

Physical activity+ MED diet

OTHER

Physical activity+green MED diet

\*\*\*\*Sub-study from all 3 main arms: Autologous fecal microbiota supplement intervention derived from the time of maximal weight loss: At the 6-month time period, the time of anticipated greatest weight reduction, participants's feces samples will be processed to capsulized inocula. Samples will be frozen within 2 hours and will be kept at -80c pending analysis. Participants will be randomized to receive either research capsules or identical placebo capsules between 8 and 14 months time period. Placebo capsules will consist of a combination of powdered cocoa and vegetable gelatin in normal saline/glycerol and will be identical in appearance to research capsules.

Sponsors & Collaborators

  • Harvard School of Public Health (HSPH)

    collaborator OTHER

  • University of Leipzig

    collaborator OTHER

  • Ben-Gurion University of the Negev

    lead OTHER

Principal Investigators

  • Iris Shai, PhD · Ben-Gurion University of the Negev

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2019-03-31
Completion
2019-03-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03020186 on ClinicalTrials.gov