Fibersol-2 Clinical Trials Related to Appetite

Lack of Satiety Clinical Trial

Official title:

Fibersol-2 Clinical Trials Related to Appetite

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01305291
• Other study ID #: ADM FB2-1 Hendrich
• Secondary ID: 08-291
• Status: Completed
• Phase: N/A
• First received: February 25, 2011
• Last updated: February 25, 2011
• Start date: November 2008
• Est. completion date: November 2009

Study information

• Verified date: February 2011
• Source: Iowa State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Emerging research suggests fiber, particularly digestion-resistant maltodextrins such as Fibersol-2, may impact satiety, by decreasing hunger, prolonging satiation, and/or increasing satiety signals from the gut. This research aims to determine whether or not Fibersol-2 may impact satiety, by decreasing hunger, prolonging satiation, and/or increasing satiety signals from the gut.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 62 Years

Eligibility

Inclusion Criteria:

i. No known food allergies

ii. Normal healthy individuals

iii. No food intake abnormalities or abnormal feeding behaviors

iv. Average American BMI (21-28)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Lack of Satiety

Intervention

Other:
• placebo

Dietary Supplement:
• digestion-resistant maltodextrin

Locations

Country	Name	City	State
United States	Nutrition and Wellness Research Center	Ames	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
Iowa State University	Archer Daniels Midland Co.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analog scale questionnaire subjective satiety responses	Hunger survey (30 minutes before meal and every half hour for 4 hours postprandial) (analogue scores)	4 hours	No
Primary	serum cholecystokinin (CCK)	0, 30, 60, 120, 180, and 240 min post-meal	4 hours	No
Primary	serum peptide YY (PYY)	0, 30, 60, 120, 180, and 240 min post-meal	4 hours	No
Primary	serum glucagon-like peptide-1 (GLP-1)	0, 30, 60, 120, 180, and 240 min post-meal	4 hours	No
Primary	serum ghrelin	0, 30, 60, 120, 180, and 240 min post-meal	4 hours	No
Primary	serum gastric inhibitory peptide (GIP)	0, 30, 60, 120, 180, and 240 min post-meal	4 hours	No
Secondary	serum total cholesterol	0, 30, 60, 120, 180, 240 min	4 hours	No
Secondary	serum LDL-cholesterol	0, 30, 60, 120, 180, 240 min	4 hours	No
Secondary	serum HDL-cholesterol	0, 30, 60, 120, 180, 240 min	4 hours	No
Secondary	serum triglycerides	0, 30, 60, 120, 180, 240 min	4 hours	No
Secondary	serum free fatty acids	0, 30, 60, 120, 180, 240 min	4 hours	No
Secondary	serum glucose	0, 30, 60, 90, 120 min	2 hours	No
Secondary	serum insulin	0, 30, 60, 90, 120 min	2 hours	No
Secondary	gastrointestinal symptoms questionnaire	subjects recorded incidents and severity of gastrointestinal symptoms post treatment over 24 h	24 h	Yes