Appetitive BehaviorNCT04601025
The Effect of Different Types of Plant-Based Fiber in a Protein-Containing Meal During Satiety and Hunger States
A study testing Yoghurt, Chickpea+Yoghurt and Oat+Yoghurt in people with Appetitive Behavior and Satiety, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Appetitive Behavior, Satiety
- What is being tested?
- Yoghurt, Chickpea+Yoghurt and Oat+Yoghurt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 May 2019to 10 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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,
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- Abnormal thyroid problem,
- Gastrointestinal disorder,
- Food allergy or intolerance
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Appetitive Behavior, Satiety
- Being tested
- Yoghurt, Chickpea+Yoghurt, Oat+Yoghurt
- Keywords
- appetite, fiber, protein, satiety
- Medical subject headings
- Appetitive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YoghurtDietary supplement
200 ml plain full-fat yoghurt
Chickpea+YoghurtDietary supplement
80 ml plain full-fat yoghurt + 70 gr cooked chickpea
Oat+YoghurtDietary supplement
80 ml plain full-fat yoghurt + 100 gr cooked oat
| Study group | Role | What they receive |
|---|---|---|
| Yoghurt | Experimental | Not described Receives: Dietary Supplement: Yoghurt |
| Chickpea+Yoghurt | Experimental | Not described Receives: Dietary Supplement: Chickpea+Yoghurt |
| Oat+Yoghurt | Experimental | Not described Receives: Dietary Supplement: Oat+Yoghurt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Satiety
Appetite will be examined using visual analog scale (0-10) with five questions: 0 least and 10 greatest
Measured: 0, 30, 60, 90 and 120 minutes after test food consumption
Baseline and postprandial blood glucose concentration
Blood glucose concentration before and at the end of 120.minutes after test food intake
Measured: Up to 120. minutes
Ad libitum lunch intake
Quantification of lunch intake after the 120 minutes of test food consumption
Measured: End of the 120.minutes
Secondary outcomes (1)
Quantification of food intake during the rest of the day
24-hours food consumption record from the end of the ad libitum lunch until the next day 9.00 AM.
Measured: During the 24-hours of experimental day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start28 May 2019
- Primary completion24 Jun 2019
- Study completion10 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appetitive BehaviorStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Collaborators
- Medipol University
- Responsible party
- Principal investigator, Hilal Hizli Güldemir, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04601025
- Sponsor's protocol ID
- CL10840098
- Status last verified
- Oct 2020
- First submitted
- 19 Oct 2020
- Last updated
- 27 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Types of Plant-Based Fiber in a Protein-Containing Meal During Satiety and Hunger States
- ClinicalTrials.gov ID
- NCT04601025
- Acronym / sponsor ID
- CL10840098
- Conditions
- Appetitive Behavior, Satiety
- Keywords
- appetite, fiber, protein, satiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Collaborators
- Medipol University
- Study start
- 28 May 2019 (actual)
- Primary completion
- 24 Jun 2019 (actual)
- Study completion
- 10 Oct 2019 (actual)
- First posted
- 23 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Yoghurt | Experimental | Dietary Supplement: Yoghurt |
| Chickpea+Yoghurt | Experimental | Dietary Supplement: Chickpea+Yoghurt |
| Oat+Yoghurt | Experimental | Dietary Supplement: Oat+Yoghurt |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (8 listed)
- Individuals who smoke,
- Follow a special diet program,
- Having eating disorder,
- Vegan or vegetarian,
- Do not consume legumes,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoghurt200 ml plain full-fat yoghurt | Dietary supplement | Yoghurt |
| Chickpea+Yoghurt80 ml plain full-fat yoghurt + 70 gr cooked chickpea | Dietary supplement | Chickpea+Yoghurt |
| Oat+Yoghurt80 ml plain full-fat yoghurt + 100 gr cooked oat | Dietary supplement | Oat+Yoghurt |
Primary outcome
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
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
Ad libitum lunch intake
Time frame: End of the 120.minutes
Quantification of lunch intake after the 120 minutes of test food consumption
1 secondary outcome
Quantification of food intake during the rest of the day
Time frame: During the 24-hours of experimental day.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoghurt, Chickpea+Yoghurt and Oat+Yoghurt in people with Appetitive Behavior and Satiety, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Satiety (time frame: 0, 30, 60, 90 and 120 minutes after test food consumption). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2020.