Assessing Fermentability of a Dietary Fiber

Nutritional Intervention Clinical Trial

— FCHO  

Official title:

Assessing Fermentability of a Dietary Fiber (FCHO) in Healthy Non-obese Men and Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01497249
• Other study ID #: FCHO 2011-086
• Status: Completed
• Phase: N/A
• Start date: December 1, 2011
• Est. completion date: September 28, 2012

Study information

• Verified date: July 2021
• Source: Clinical Nutrition Research Center, Illinois Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to provide evidence for its fermentability of a dietary fiber and to collect information regarding potential health opportunities for glucose control as well as tolerability when being consumed over 7 days.

Description:

This study is designed as a randomized, 2-arm, treatment-controlled, within-subjects, 8-hour postprandial crossover study, utilizing a multiple sampling paradigm to evaluate fermentability and potential health opportunities for glucose control of a dietary fiber (FCHO) in healthy non-obese men and women. The study will include 2 - 8 h assessments following consumption of the FCHO drink or a placebo drink and will follow with a 7 day feeding period to assess tolerability.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: September 28, 2012
• Est. primary completion date: September 28, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 18 years of age or older

• BMI between 18.5 and 29.9 kg/m2, inclusive

• No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal, or hepatic disease

• No diabetes

• No Gastrointestinal issues

Exclusion Criteria:

• Pregnant and/or lactating or planning for pregnancy

• Allergies or intolerances to foods consumed in the study Fasting blood glucose > 125 mg/dL.

• Vegetarian

• Taking over the counter fiber supplements or other supplements that may interfere with the study procedures or endpoints

• Taking actively probiotics or purposely taking/ subscribing to a diet high in prebiotics.

• Taking prescription medications that may interfere with study procedures or endpoints (eg., antibiotics)

• Subjects with unusual dietary habits (e.g. pica)

• Actively losing weight or trying to lose weight (unstable body weight fluctuations of > 5 kg in a 60 day period)

• Excessive exercisers or trained athletes

• Addicted to drugs and/or alcohol

• Medically documented psychiatric or neurological disturbances

• Smokers (past smokers may be allowed if cessation is > 2 years)

Related Conditions & MeSH terms

• Nutritional Intervention

Intervention

Dietary Supplement:
• A dietary fiber (FCHO)
15 g twice per day in beverage
• Placebo
Placebo drink

Locations

Country	Name	City	State
United States	Clinical Nutrition Research Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Clinical Nutrition Research Center, Illinois Institute of Technology	Ingredion Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The fermentation action of a dietary fiber (FCHO) provided in a breakfast test meal in relatively healthy non-obese men and women	FCHO will be incorporated in a breakfast meal and compared to the same meal without the FCHO. Subjects will be served a breakfast meal with FCHO or without FCHO in a randomly assigned sequence on two separate occasions (visit 1 and visit 2) under fasting conditions.; Hydrogen (H2) from breath will be measured before the breakfast test meal (baseline/fasting) and every hour: at 1hr, 2hr, 3hr, 4hr, 5hr, 6 hr, 7hr, and 8hr.	8 hours
Secondary	The changes in postprandial glucose concentrations after consuming test meals with FCHO drink compared to placebo drink	FCHO will be incorporated in a breakfast meal and compared to the same meal without the FCHO. Subjects will be served a breakfast meal with FCHO or without FCHO in a randomly assigned sequence on two separate occasions (visit 1 and visit 2) under fasting conditions.; Blood glucose will be measured before (fasting/baseline) and after breakfast test meal intake for 4hrs: 0, 30 min, 60 min, 120 min, and 240 min and then again after the light lunch meal at 30, 60, 90, 120 post lunch.	8 hours
Secondary	The tolerability of treatments over 7 days	After the in-lab study day (visit 1 and visit 2), subjects will go home with the test beverage packs to be consumed daily for 7 days. Subjects will maintain diaries to ensure daily consumption and on day 7 will be asked to complete a brief questionnaire related to gastrointestinal experiences during the week. Identical procedures will take place after both study days, except the assigned treatment will differ.	7 days