Dietary FibersNCT04633369
The Role of the Microbiome in the Response to Dietary Fibers Intake During Intermittent Fasting
A study testing dietary fibers and Intermediate fasting in people with Dietary Fibers and Intermediate Fasting, run by Weizmann Institute of Science at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Fibers, Intermediate Fasting
- What is being tested?
- dietary fibers and Intermediate fasting
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteIsrael
- Study dates
- 21 Apr 2021to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and Female BMI<28 Age - 18-70
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of the Microbiome and Host Physiology in Personalized Human Response to Dietary Fibers Intake During Intermittent 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.
Read the detailed 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 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.
- Conditions
- Dietary Fibers, Intermediate Fasting
- Being tested
- dietary fibers, Intermediate fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary fibersDietary supplement
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.
Intermediate fastingOther
Intermediate fasting regime, which will include: 16 straight hours of fasting followed by 8 hours which the participants will be allowed to eat.
| Study group | Role | What they receive |
|---|---|---|
| Fructo-oligosaccharide | Experimental | Fructo-oligosaccharide 20g Receives: Dietary Supplement: dietary fibers |
| Arabinogalactan | Experimental | Arabinogalactan 12g Receives: Dietary Supplement: dietary fibers |
| Glucomannan | Experimental | Glucomannan 4g Receives: Dietary Supplement: dietary fibers |
| Fructo-oligosaccharide with intermittent fasting | Experimental | 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. Receives: Dietary Supplement: dietary fibers; Other: Intermediate fasting |
| Arabinogalactan with intermittent fasting | Experimental | 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. Receives: Dietary Supplement: dietary fibers; Other: Intermediate fasting |
| Glucomannan with intermittent fasting | Experimental | 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. Receives: Dietary Supplement: dietary fibers; Other: Intermediate fasting |
| Fasting without dietary fiber consumption | Experimental | intermittent fasting regime, which will include: 16 straight hours of fasting followed by 8 hours which the participants will be allowed to eat. Receives: Other: Intermediate fasting |
| Without fasting and without dietary fiber consumption | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
microbiome
stool and oral samples
Measured: 1 year
glycemic response of different dietary fibers
Continuous glucose monitoring (CGM)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start21 Apr 2021
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary FibersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weizmann Institute of Science
- Sponsor type
- University, hospital or other
- Collaborators
- Hadassah Medical Organization
- Responsible party
- Sponsor
- Investigators
- Eran Elinav, Prof, Principal investigator, Weizmann Institute of ScienceHila Elinav, Prof, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04633369
- Sponsor's protocol ID
- MHO-0488-20
- Status last verified
- Mar 2026
- First submitted
- 12 Nov 2020
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Microbiome and Host Physiology in Personalized Human Response to Dietary Fibers Intake During Intermittent Fasting
- ClinicalTrials.gov ID
- NCT04633369
- Acronym / sponsor ID
- MHO-0488-20
- Conditions
- Dietary Fibers, Intermediate Fasting
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Weizmann Institute of ScienceUniversity, hospital or other
- Collaborators
- Hadassah Medical Organization
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 18 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Fructo-oligosaccharide | Experimental | Dietary Supplement: dietary fibersFructo-oligosaccharide 20g |
| Arabinogalactan | Experimental | Dietary Supplement: dietary fibersArabinogalactan 12g |
| Glucomannan | Experimental | Dietary Supplement: dietary fibersGlucomannan 4g |
| Fructo-oligosaccharide with intermittent fasting | Experimental | Dietary Supplement: dietary fibers, Other: Intermediate fastingFructo-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 fastingArabinogalactan 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 fastingGlucomannan 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 fastingintermittent 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male and Female BMI<28 Age - 18-70
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dietary fibersduring 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. | Dietary supplement | Arabinogalactan, Arabinogalactan with intermittent fasting, Fructo-oligosaccharide, Fructo-oligosaccharide with intermittent fasting, Glucomannan, Glucomannan with intermittent fasting |
| Intermediate fastingIntermediate fasting regime, which will include: 16 straight hours of fasting followed by 8 hours which the participants will be allowed to eat. | Other | Arabinogalactan with intermittent fasting, Fasting without dietary fiber consumption, Fructo-oligosaccharide with intermittent fasting, Glucomannan with intermittent fasting |
Primary outcome
microbiome
Time frame: 1 year
stool and oral samples
glycemic response of different dietary fibers
Time frame: 1 year
Continuous glucose monitoring (CGM)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
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The High Fiber Program to Increase Fiber Intake Among Patients Undergoing Allogeneic Hematopoietic Cell Transplant
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Evaluation of the Prevalence, and Immunological Characteristics of Small Fiber Neuropathy in Patients With Primary Sjögren's Syndrome
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Stanford University Neurofiber Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eran Elinav, Prof principal investigator
Weizmann Institute of Science
Hila Elinav, Prof principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary fibers and Intermediate fasting in people with Dietary Fibers and Intermediate Fasting, run by Weizmann Institute of Science at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
microbiome (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.