Focus of the Study is on Gut Health
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENTDietary Fiber
Dietary fiber will be added to study foods
Sponsors
Ingredion Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metabolizable energy | 7 days, 3 times | Urine and feces will be collected for 7 days at the end of each treatment period to allow for assessment of metabolizable energy |
| Fermentability | One, eight-hr day, three times | Breath hydrogen will be measured hourly, over eight hours at the end of each treatment period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fecal microbiota | 2 days, three times, and 7 days, three times | Fecal samples will be collected for 7 days at the end of each treatment period and for two days during washout periods |
| Blood glucose | For eight hours, three times | An indwelling catheter will be placed and blood samples will be drawn over the course of an eight-hour period, at the end of each treatment period |
Countries
United States
Outcome results
None listed