FCHO: Assessing Fermentability of a Dietary Fiber

• Sponsor: Clinical Nutrition Research Center, Illinois Institute of Technology (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01497249
• Collaborator: Ingredion Incorporated (Industry)
• Enrollment: 29
• Location: 1
• Arms: 2
• Actual Duration (Months): 9.9
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Nutritional Intervention	Dietary Supplement: A dietary fiber (FCHO); Dietary Supplement: Placebo	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 29 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Assessing Fermentability of a Dietary Fiber (FCHO) in Healthy Non-obese Men and Women
• Actual Study Start Date: Dec 1, 2011
• Actual Primary Completion Date: Sep 28, 2012
• Actual Study Completion Date: Sep 28, 2012

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Placebo Beverage	Dietary Supplement: Placebo; Placebo drink; Other Names: PCB
Active Comparator: A dietary fiber (FCHO) 15g/BID	Dietary Supplement: A dietary fiber (FCHO); 15 g twice per day in beverage; Other Names: FCHO

Outcome Measures

Primary Outcome Measures

1. The fermentation action of a dietary fiber (FCHO) provided in a breakfast test meal in relatively healthy non-obese men and women [8 hours]

   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.

Secondary Outcome Measures

1. The changes in postprandial glucose concentrations after consuming test meals with FCHO drink compared to placebo drink [8 hours]

   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.

2. The tolerability of treatments over 7 days [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Nutrition Research Center	Chicago	Illinois	United States	60616

Sponsors and Collaborators

• Clinical Nutrition Research Center, Illinois Institute of Technology
• Ingredion Incorporated

Investigators

• Principal Investigator: Britt Burton-Freeman, Ph.D, Illinois Institute for Technology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Clinical Nutrition Research Center, Illinois Institute of Technology
• ClinicalTrials.gov Identifier: NCT01497249
• Other Study ID Numbers: FCHO 2011-086
• First Posted: Dec 22, 2011
• Last Update Posted: Jul 27, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Clinical Nutrition Research Center, Illinois Institute of Technology: Dietary Fiber; Blood glucose control; Fermentability; Tolerability

Study Results

No Results Posted as of Jul 27, 2021