Assessing Fermentability of a Dietary Fiber

NCT01497249 | Completed

• 1 other identifier: FCHO 2011-086
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Nutritional Intervention

Keywords

Dietary Fiber; Blood glucose control; Fermentability; Tolerability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The changes in postprandial glucose concentrations after consuming test meals with FCHO drink compared to placebo drink

  8 hours

• The tolerability of treatments over 7 days

  7 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo Beverage

Dietary Supplement: Placebo

A dietary fiber (FCHO)

ACTIVE COMPARATOR

15g/BID

Dietary Supplement: A dietary fiber (FCHO)

Interventions

A dietary fiber (FCHO) DIETARY_SUPPLEMENT

15 g twice per day in beverage

Also known as: FCHO

A dietary fiber (FCHO)

Placebo DIETARY_SUPPLEMENT

Placebo drink

Also known as: PCB

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Clinical Nutrition Research Center

Chicago, Illinois, 60616, United States

Location

Study Officials

• Britt Burton-Freeman, Ph.D

  Illinois Institute for Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2011
• First Posted: December 22, 2011
• Study Start: December 1, 2011
• Primary Completion: September 28, 2012
• Study Completion: September 28, 2012
• Last Updated: July 27, 2021

Record last verified: 2021-07

Locations

US (1)