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Completed

NCT Number: NCT01100788

Satiety Response of Short Chain Fructooligosaccharide

Populations that report high fiber consumption demonstrate lower rates of obesity. Enhanced satiety may play a key role in this relationship. The colonic fermentation of fibers is theorized to influence satiety and food intake. Short chain fructooligosaccharide (scFOS) are rapidly fermentable fibers that can easily be added to foods to impact these parameters.

The objective of this study was to evaluate the satiety response of scFOS and its ability to decrease food intake.

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Key information

Conditions

Healthy

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Minnesota

Saint Paul, Minnesota, 55108, United States

About this study

Intervention study with fiber added to beverages and acute effects on satiety measured.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy men and women
  • Age 18-64 years
  • Non-smoking
  • Not taking medication
  • Non-dieting (weight stable in prior 3 months)
  • BMI 18-27
  • English literacy

Exclusion criteria

  • Do not regularly consume breakfast
  • Food allergies to ingredients found in study products
  • BMI <18 or >27
  • Diagnosed cardiovascular, renal, or hepatic disease diabetes mellitus
  • Cancer in previous 5 years (except basal cell carcinoma of the skin)
  • Any gastrointestinal disease or condition
  • Recent bacterial infection (< 3 months)
  • Recent or concurrent participation in an intervention research study
  • History of drug or alcohol abuse in prior 6 months
  • Use of lipid-lowering, anti-hypertensive, or anti-inflammatory steroid medication
  • Eating disorder
  • Vegetarians
  • People who eat more than approximately 15 grams of fiber per day
  • Women who are pregnant or lactating
  • Women with irregular menstrual cycles

Treatment and study plan

Short chain fructo-oligosaccharide (scFOS) 5 g

Dietary Supplement

Dietary Supplement: scFOS 5 g

Novel fiber administered in two 5 g doses--the first in a beverage and the second in a solid chew.

Other names: fructo-oligosaccharide

Placebo

Other

Treatment without scFOS fiber

Short chain fructooligosaccharide (scFOS) 8 g

Dietary Supplement

Novel fiber administered in two 8 g doses--the first in a beverage and the second in a solid chew.

Primary outcomes

  1. Satiety response using visual analogue scales

    Time frame: 0, 15, 30, 45, 60, 90, 120, 180, 240 minutes postprandially

    Satiety response was measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).

Secondary outcomes

  1. Ad libitum food intake

    Time frame: 240 minutes postprandially and over 24 hours

  2. Breath hydrogen response

    Time frame: 0, 240 minutes

  3. Gastrointestinal tolerance using visual analogue scales (VAS)

    Time frame: 24 hours

    Subjective ratings of bloating, stool consistency, and flatulence on VAS. A stool count was also recorded.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Apr 9, 2010
Registry last updated
Apr 9, 2010

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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