Satiety Response of Short Chain Fructooligosaccharide

NCT01100788 | Completed Early Phase 1

• 1 other identifier: 0806M37444
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Satiety response using visual analogue scales

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

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

Secondary Outcomes (3)

• Ad libitum food intake

  240 minutes postprandially and over 24 hours

• Breath hydrogen response

  0, 240 minutes

• Gastrointestinal tolerance using visual analogue scales (VAS)

  24 hours

Study Arms (3)

Placebo

PLACEBO COMPARATOR

No treatment

Other: Placebo

scFOS 5 g

EXPERIMENTAL

5 g scFOS

Dietary Supplement: Short chain fructo-oligosaccharide (scFOS) 5 g

scFOS 8 g

EXPERIMENTAL

8 g scFOS

Dietary Supplement: Short chain fructooligosaccharide (scFOS) 8 g

Interventions

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.

Also known as: fructo-oligosaccharide

scFOS 5 g

Placebo OTHER

Treatment without scFOS fiber

Placebo

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.

scFOS 8 g

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Saint Paul, Minnesota, 55108, United States

Location

MeSH Terms

Interventions

fructo-oligosaccharide-shitake

Study Officials

• Joanne Slavin

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 5, 2010
• First Posted: April 9, 2010
• Study Start: March 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: April 9, 2010

Record last verified: 2010-04

Locations

US (1)