Fibersol-2 Clinical Trials Related to Appetite

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01305291

Enrollment

Registered

2011-02-28

Start date

2008-11-30

Completion date

2009-11-30

Last updated

2011-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lack of Satiety

Keywords

dietary fiber, satiety response, hunger, CCK, PYY, ghrelin, GIP, GLP-1

Brief 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.

Interventions

OTHERplacebo

DIETARY_SUPPLEMENTdigestion-resistant maltodextrin

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 62 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
Visual analog scale questionnaire subjective satiety responses	4 hours	Hunger survey (30 minutes before meal and every half hour for 4 hours postprandial) (analogue scores)
serum cholecystokinin (CCK)	4 hours	0, 30, 60, 120, 180, and 240 min post-meal
serum peptide YY (PYY)	4 hours	0, 30, 60, 120, 180, and 240 min post-meal
serum glucagon-like peptide-1 (GLP-1)	4 hours	0, 30, 60, 120, 180, and 240 min post-meal
serum ghrelin	4 hours	0, 30, 60, 120, 180, and 240 min post-meal
serum gastric inhibitory peptide (GIP)	4 hours	0, 30, 60, 120, 180, and 240 min post-meal

Secondary

Measure	Time frame	Description
serum insulin	2 hours	0, 30, 60, 90, 120 min
serum total cholesterol	4 hours	0, 30, 60, 120, 180, 240 min
gastrointestinal symptoms questionnaire	24 h	subjects recorded incidents and severity of gastrointestinal symptoms post treatment over 24 h
serum LDL-cholesterol	4 hours	0, 30, 60, 120, 180, 240 min
serum HDL-cholesterol	4 hours	0, 30, 60, 120, 180, 240 min
serum triglycerides	4 hours	0, 30, 60, 120, 180, 240 min
serum free fatty acids	4 hours	0, 30, 60, 120, 180, 240 min
serum glucose	2 hours	0, 30, 60, 90, 120 min

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026