Effects of a Dietary Fiber on Fecal Microbiota and Metabolism (NCT01518088) | Clinical Trial Compass
CompletedNot Applicable
Effects of a Dietary Fiber on Fecal Microbiota and Metabolism
United States20 participantsStarted 2012-02
Plain-language summary
The purpose of the study is to examine how a dietary fiber affects metabolism in healthy overweight and obese adults. The fiber will be added to foods that participants will consume for two, three-week periods. The fiber will be given in two doses -- 15 g per day during one period, and 30 g per day in the other. In another three-week period, they will consume the same foods, but with no fiber added. Major outcomes will include fermentability of the fiber, as assessed by measurement of breath hydrogen, as well as shifts in fecal bacteria. The caloric value of the fiber will be determined and metabolic measures related to blood glucose control and inflammation will also be taken.
Who can participate
Age range
20 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Body mass index from 25 to 35 kg/m2.
* Willing to consume study foods and comply with dietary exclusions and specimen collection
Exclusion Criteria:
* Pregnancy
* Diabetes
* Gastrointestinal disease
* Regular use of pre- or probiotics
* Recent use of antibiotics
* High intake of dietary fiber
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.