Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-25 @ 8:23 PM
Study NCT ID:
NCT04633369
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-25
First Post:
2020-11-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Role of the Microbiome in the Response to Dietary Fibers Intake During Intermediate Fasting
Sponsor:
Weizmann Institute of Science
Organization:
Study Overview
Official Title:
The Role of the Microbiome and Host Physiology in Personalized Human Response to Dietary Fibers Intake During Intermediate Fasting
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: