- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04596969
The Effect of Soluble Fiber Dextrin on Subjective and Physiological Markers of Appetite
October 15, 2020 updated by: Iowa State University
The Effect of Soluble Fiber Dextrin on Subjective and Physiological Markers of Appetite: a Randomized Trial
This study examines the effect of soluble fiber dextrin on food intake, appetite, and physiological markers of appetite.
Adults aged 18-45 years with a BMI were recruited for this study.
Participants were given two doses of SFD in the morning and appetite, food intake and physiological markers of appetite were measured over 10 years.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Overweight and obesity are leading health problems.
The study investigates the effect of a food ingredient from two different sources at two different doses on food intake and appetite markers over a 10 hour period.
All participants reported to the laboratory first thing in the morning and remained in the laboratory until after their evening meal.
A fixed breakfast was served but the participants were free to eat as much as they liked at lunch and dinner.
Blood was taken at regular intervals during the day and assayed for glucose and several hormones related to appetite.
Subjective measures of appetite were also collected over the 10 hour test session.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
BMI 19.9 - 29.9 Aged 18-45 Find the study foods to be palatable
Exclusion Criteria:
Weight change > 3kg in the past three months Do not regularly consume snacks Presence or history of GI disorders Restrained eater Used medication that influences appetite
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Control
Maltodextrin
|
Ingredient based on resistant starch
|
|
Experimental: SFD Tapioca 20g
20g soluble fiber dextrin derived from tapioca
|
Ingredient based on resistant starch
|
|
Experimental: SFD Tapioca 40g
40g soluble fiber dextrin derived from tapioca
|
Ingredient based on resistant starch
|
|
Experimental: SFD corn 20g
40g soluble fiber dextrin derived from corn
|
Ingredient based on resistant starch
|
|
Experimental: SFD corn 40g
|
Ingredient based on resistant starch
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Food intake
Time Frame: 10 hours
|
Food intake measured at lunch and evening meal.
|
10 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Appetite
Time Frame: 10 hours
|
Subjective appetite measures using questionnaires at regular intervals over 10 hours,
|
10 hours
|
|
CCK
Time Frame: 10 hours
|
Plasma CCK measured at regular intervals over 10 hours.
|
10 hours
|
|
GLP-1
Time Frame: 10 hours
|
Plasma GLP-1 measured at regular intervals over 10 hours.
|
10 hours
|
|
PYY3-36
Time Frame: 10 hours
|
Plasma PYY3-36 measured at regular intervals over 10 hours.
|
10 hours
|
|
Breath Hydrogen
Time Frame: 10 hours
|
Breath hydrogen measured at regular intervals over 10 hours.
|
10 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2014
Primary Completion (Actual)
January 1, 2017
Study Completion (Actual)
January 1, 2018
Study Registration Dates
First Submitted
October 15, 2020
First Submitted That Met QC Criteria
October 15, 2020
First Posted (Actual)
October 22, 2020
Study Record Updates
Last Update Posted (Actual)
October 22, 2020
Last Update Submitted That Met QC Criteria
October 15, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- SFDISU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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