Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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 Intervention
Nutritional Intervention
Dietary Supplement: A dietary fiber (FCHO)
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Assessing Fermentability of a Dietary Fiber (FCHO) in Healthy Non-obese Men and Women

Resource links provided by NLM:


Further study details as provided by Institute for Food Safety and Health, United States:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.


Enrollment: 29
Study Start Date: December 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo Beverage
Dietary Supplement: Placebo
Placebo drink
Other Name: PCB
Active Comparator: A dietary fiber (FCHO)
15g/BID
Dietary Supplement: A dietary fiber (FCHO)
15 g twice per day in beverage
Other Name: FCHO

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01497249

Locations
United States, Illinois
Clinical Nutrition Research Center
Chicago, Illinois, United States, 60616
Sponsors and Collaborators
Institute for Food Safety and Health, United States
National Starch LLC
Investigators
Principal Investigator: Britt Burton-Freeman, Ph.D Illinois Institute for Technology
  More Information

No publications provided

Responsible Party: Institute for Food Safety and Health, United States
ClinicalTrials.gov Identifier: NCT01497249     History of Changes
Other Study ID Numbers: FCHO 2011-086
Study First Received: December 20, 2011
Last Updated: November 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Institute for Food Safety and Health, United States:
Dietary Fiber
Blood glucose control
Fermentability
Tolerability

ClinicalTrials.gov processed this record on November 24, 2014