- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04601025
The Effect of Different Types of Plant-Based Fiber in a Protein-Containing Meal During Satiety and Hunger States
October 26, 2020 updated by: Hilal Hizli Güldemir, Kutahya Health Sciences University
The study was carried out once a week on the same day and for three-week duration, with total of 17 randomly selected participants with ages between 18 and 24 years.
The test foods containing different vegetable fiber sources (chickpeas and oats) were given to the participants every week as isocaloric, which have been the control food for a week.
The satiety status was evaluated by visual analog scale (VAS) for total of five times as immediately before the test food consumption and at 30, 60, 90 and 120 minutes after consumption.
Fasting and postprandial blood glucose levels were measured.
A 24-hour retrospective food consumption record was obtained the next day.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey
- Medipol University
-
-
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 25 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Age range of 18-24 years,
- Studying at the university,
- Not smoking,
- Having normal BMI according to the World Health Organization (18.5-24.9 kg / m2),
- Satisfy blood donation criteria,
- Along with not suffering from diabetes,
- Abnormal thyroid problem,
- Gastrointestinal disorder,
- Food allergy or intolerance
Exclusion Criteria:
- Individuals who smoke,
- Follow a special diet program,
- Having eating disorder,
- Vegan or vegetarian,
- Do not consume legumes,
- Having gluten or lactose intolerance,
- Suffering from a chronic disease,
- Pregnant or breastfeeding
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Yoghurt
|
200 ml plain full-fat yoghurt
|
|
Experimental: Chickpea+Yoghurt
|
80 ml plain full-fat yoghurt + 70 gr cooked chickpea
|
|
Experimental: Oat+Yoghurt
|
80 ml plain full-fat yoghurt + 100 gr cooked oat
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of Satiety
Time Frame: 0, 30, 60, 90 and 120 minutes after test food consumption
|
Appetite will be examined using visual analog scale (0-10) with five questions: 0 least and 10 greatest
|
0, 30, 60, 90 and 120 minutes after test food consumption
|
|
Baseline and postprandial blood glucose concentration
Time Frame: Up to 120. minutes
|
Blood glucose concentration before and at the end of 120.minutes after test food intake
|
Up to 120. minutes
|
|
Ad libitum lunch intake
Time Frame: End of the 120.minutes
|
Quantification of lunch intake after the 120 minutes of test food consumption
|
End of the 120.minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quantification of food intake during the rest of the day
Time Frame: During the 24-hours of experimental day.
|
24-hours food consumption record from the end of the ad libitum lunch until the next day 9.00 AM.
|
During the 24-hours of experimental day.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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)
May 28, 2019
Primary Completion (Actual)
June 24, 2019
Study Completion (Actual)
October 10, 2019
Study Registration Dates
First Submitted
October 19, 2020
First Submitted That Met QC Criteria
October 19, 2020
First Posted (Actual)
October 23, 2020
Study Record Updates
Last Update Posted (Actual)
October 27, 2020
Last Update Submitted That Met QC Criteria
October 26, 2020
Last Verified
October 1, 2020
More Information
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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