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Completed

NCT Number: NCT01497249

Assessing Fermentability of a Dietary Fiber

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.

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Key information

Conditions

Nutritional Intervention

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Nutrition Research Center

Chicago, Illinois, 60616, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

A dietary fiber (FCHO)

Dietary Supplement

15 g twice per day in beverage

Other names: FCHO

Placebo

Dietary Supplement

Placebo drink

Other names: PCB

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

    Time frame: 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 outcomes

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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Clinical Nutrition Research Center, Illinois Institute of Technology

Industry

Collaborators

  • Ingredion Incorporated

Registry information

Official study title

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

Acronym: FCHO

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 22, 2011
Registry last updated
Jul 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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