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Assessing Fermentability of a Dietary Fiber (FCHO)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Starch LLC
Information provided by (Responsible Party):
Institute for Food Safety and Health, United States
ClinicalTrials.gov Identifier:
NCT01497249
First received: December 20, 2011
Last updated: November 21, 2013
Last verified: November 2013

December 20, 2011
November 21, 2013
December 2011
March 2014   (final data collection date for primary outcome measure)
The fermentation action of a dietary fiber (FCHO) provided in a breakfast test meal in relatively healthy non-obese men and women [ Time Frame: 8 hours ] [ Designated as safety issue: No ]

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.

The fermentation action of a novel carbohydrate fiber (FCHO) provided in a breakfast test meal in relatively healthy non-obese men and women [ Time Frame: 8 hours ] [ Designated as safety issue: No ]

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.

Complete list of historical versions of study NCT01497249 on ClinicalTrials.gov Archive Site
  • The changes in postprandial glucose concentrations after consuming test meals with FCHO drink compared to placebo drink [ Time Frame: 8 hours ] [ Designated as safety issue: No ]

    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.

  • The tolerability of treatments over 7 days [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
Assessing Fermentability of a Dietary Fiber
Assessing Fermentability of a Dietary Fiber (FCHO) in Healthy Non-obese Men and Women

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Nutritional Intervention
  • Dietary Supplement: A dietary fiber (FCHO)
    15 g twice per day in beverage
    Other Name: FCHO
  • Dietary Supplement: Placebo
    Placebo drink
    Other Name: PCB
  • Placebo Comparator: Placebo
    Placebo Beverage
    Intervention: Dietary Supplement: Placebo
  • Active Comparator: A dietary fiber (FCHO)
    15g/BID
    Intervention: Dietary Supplement: A dietary fiber (FCHO)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
29
March 2014
March 2014   (final data collection date for primary outcome measure)

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)
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01497249
FCHO 2011-086
No
Institute for Food Safety and Health, United States
Institute for Food Safety and Health, United States
National Starch LLC
Principal Investigator: Britt Burton-Freeman, Ph.D Illinois Institute for Technology
Institute for Food Safety and Health, United States
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP