Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04633369
Other study ID # MHO-0488-20
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 21, 2021
Est. completion date August 2025

Study information

Verified date December 2023
Source Weizmann Institute of Science
Contact Aurelie Bukimer, Bsc
Phone +97289529173
Email aurelie.bukimer@weizmann.ac.il
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Dietary fibers are generally not degraded by the endogenous digestive enzymes, but rather by the complex ensemble of microorganisms that reside in the human gut [1]. This ensemble, collectively known as the human gut microbiome, plays a key role in breaking down, fermenting, and ultimately converting such dietary fibers into a variety of beneficial metabolites, including most notably, short chain fatty acids (SCFA). These end products of fibers' fermentation affect host metabolism, immunity, and physiology, and have been implicated in multiple diseases including obesity, metabolic syndrome, diabetes, and cardiovascular diseases. Intermediate fasting, and in particular circadian intermediate fasting (i.e. 16 hours of fasting followed by 8 hours of allowed eating), has been shown to have positive associations with multiple health conditions as obesity, diabetes mellitus, cardiovascular disease, cancers, and neurologic disorders In this study, we will try to answer open questions utilizing the long fasting period during the day to investigate the isolated effect of dietary fiber consumption, uncovering the degradation effect, but not the bulking effect, on the microbiome and the host physiology, and in particular its glucose response.


Description:

During the 22 days of the study, participants will wear a continuous glucose monitor, fill a daily food diary, and collect stool and oral samples which will be used for microbiota profiling. Participants will be asked to carry out an intermediate fasting regime, which will include: 16 straight hours of fasting followed by 8 hours which the participants will be allowed to eat. Drinking water is allowed throughout the fasting hours. The groups will consume 4, 12, 20 grams of the dietary fiber per day, according to the group they were assigned to, while not exceeding the total fiber consumption of 50 grams per day, which is considered a high-fiber diet.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date August 2025
Est. primary completion date August 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: Male and Female BMI<28 Age - 18-70 Exclusion Criteria: Consumption of antibiotics 3 months prior to the first day of the experiment. Consumption of probiotic or dietary fibers supplements 1 month prior to the first day of the experiment. Practiced in intermediate fasting 1 month prior to the first day of the experiment. Diagnosis with type 1 or type 2 diabetes. Pregnancy, breastfeeding, or fertility treatments in the last 6 months. Chronic disease (e.g. AIDS, Cushing syndrome, CKD, acromegaly, hyperthyroidism hepatitis, fibromyalgia, etc.). Cancer and recent anticancer treatment. Psychiatric disorders. Coagulation disorders. IBD (inflammatory bowel diseases). IBS (Irritable bowel syndrome). Alcohol abuse, more than 2 drinks per day for males, and more than one drink for females. Substance abuse. BMI>28. Daily dietary intake higher than 25 grams per day. History of abdominal surgeries (including Bariatric surgery). Mentally incompetent or lack of judgment

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
dietary fibers
during days 13-22 the participants will consume the dietary fiber according to their randomization and continue fasting. Participants will be asked to collect stool and oral samples 4 times during this period.

Locations

Country Name City State
Israel Weizmann institute of science Re?ovot

Sponsors (2)

Lead Sponsor Collaborator
Weizmann Institute of Science Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary microbiome stool and oral samples 1 year
Primary glycemic response of different dietary fibers Continuous glucose monitoring (CGM) 1 year
See also
  Status Clinical Trial Phase
Completed NCT01897649 - Effect of 15g Daily Consumption of NUTRIOSE on Healthy Volunteers Microbiota. Phase 1