The Role of the Microbiome and Host Physiology in Personalized Human Response to Dietary Fibers Intake During Intermittent Fasting
| Registry | NCT04633369 |
|---|---|
| Status | Active not recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, basic science |
| Enrollment | 115 (Actual) |
| Sponsor | Weizmann Institute of Science (Other); collaborators: Hadassah Medical Organization |
| Conditions | Dietary Fibers, Intermediate Fasting |
| Interventions | dietary fibers, Intermediate fasting (Dietary supplement, other) |
| Dates | start 2021-04-21, primary completion 2026-12-01 (estimated), completion 2027-03-01 (estimated), first posted 2020-11-18, last updated 2026-10-08 |
| Locations | 1 site in Israel |
Related Papers Related Patents Related Grants Related Experts
All trials for Dietary Fibers All trials for Intermediate Fasting All trials of dietary fibers All trials of Intermediate fasting
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.
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 intermittent 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 grams of Glucomannan, 12 grams of Arabinogalactan, 20 grams of Fructo-oligosaccharideor or no fiber at all, with or without fasting according to the group they were assigned to.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Fructo-oligosaccharide | Experimental | Dietary Supplement: dietary fibers | Fructo-oligosaccharide 20g |
| Arabinogalactan | Experimental | Dietary Supplement: dietary fibers | Arabinogalactan 12g |
| Glucomannan | Experimental | Dietary Supplement: dietary fibers | Glucomannan 4g |
| Fructo-oligosaccharide with intermittent fasting | Experimental | Dietary Supplement: dietary fibers; Other: Intermediate fasting | Fructo-oligosaccharide 20g + intermittent fasting regime, which will include: 16 straight hours of fasting followed by 8 hours which the participants will be allowed to eat. |
| Arabinogalactan with intermittent fasting | Experimental | Dietary Supplement: dietary fibers; Other: Intermediate fasting | Arabinogalactan 12g + intermittent fasting regime, which will include: 16 straight hours of fasting followed by 8 hours which the participants will be allowed to eat. |
| Glucomannan with intermittent fasting | Experimental | Dietary Supplement: dietary fibers; Other: Intermediate fasting | Glucomannan 4g + intermittent fasting regime, which will include: 16 straight hours of fasting followed by 8 hours which the participants will be allowed to eat. |
| Fasting without dietary fiber consumption | Experimental | Other: Intermediate fasting | intermittent fasting regime, which will include: 16 straight hours of fasting followed by 8 hours which the participants will be allowed to eat. |
| Without fasting and without dietary fiber consumption | No intervention | No intervention |
Sex: All, ages: 18 Years to 70 Years, accepts healthy volunteers
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 fiber intake higher than 25 grams per day. History of abdominal surgeries (including Bariatric surgery). Mentally incompetent or lack of judgment
| Facility | City | Country | Status |
|---|---|---|---|
| Weizmann institute of science | Rehovot | Israel |