- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04212546
Short and Long-Term Effects of Prebiotic, Probiotic and Synbiotic on Appetite and Dietary Intake
December 25, 2019 updated by: ZEHRA BUYUKTUNCER, Hacettepe University
Prebiotics and probiotics are thought to play a role in appetite control and body weight regulation; but little is known about this topic.
This study was planned to examine the effects of inulin and Lactobacillus casei 431 on short and long term fasting, satiety, dietary intake, and serum hunger and satiety hormone levels.
The study consisted of 2 phases.
In the first phase, a double-blind, randomized, crossover study design was used, and it was performed with 16 healthy male participants aged 19-30 years.
In this phase, the prebiotic (200mL milk+16g inulin), probiotic (200mL milk + Lactobacillus casei 431 [>106 cfu/mL]+16g maltodextrin), synbiotic (200mL milk+16g inulin + Lactobacillus casei 431 [>106 cfu/mL]) and control (200mL milk+16g maltodextrin) test drinks were consumed with a standard breakfast on four separate test days by one week intervals, and their effects on dietary intake, hunger, satiety and appetite were assessed.
The second phase was performed with 21 healthy male participants aged 19-30 years, using a placebo-controlled double-blind, randomized study design.
Participants consumed the control (200mL milk+16g maltodextrin) or synbiotic (200mL milk+16g inulin+ Lactobacillus casei [>106 cfu/mL]) test drinks for 21 days with their habitual diet.
At the beginning and end of the intervention, blood samples were collected at 0., 30., 60. and 120.
minutes following the test day protocol to analyse serum glucose, insulin, ghrelin, obestatin and PYY (peptide tyrosine tyrosine) levels.
In addition, dietary intake, hunger, satiety and appetite of participants were compared.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
21
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
-
-
-
Ankara, Turkey, 06230
- Hacettepe University, Faculty of Health Sciences, Department of Nutrition and Dietetics
-
-
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
19 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy male
- 19-30 years old
- Body mass index (BMI) of 18.5-29.9 kg/m2
Exclusion Criteria:
- Being female
- Being younger than 19 years old or older than 30 years old
- Having a BMI that is lower than 18.5 kg/m2 or higher than 29.9 kg/m2
- Smoking
- Having any metabolic disease
- Losing or gaining weight in the past 3 months
- Following a special diet
- Using any medicine which could affect the outcome of the study
- Having food intolerance and allergies
- Taking regular probiotic or prebiotic foods or supplements
- Not consuming breakfast or lunch regularly
- Being a professional athlete
- Having unhealthy eating attitude that assessed using three factor eating questionnaire (having cognitive restraint score >13, uncontrolled eating score >18, and emotional eating > 6)
- Having depression that was assessed using Beck's Depression Inventory (having a score >9)
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control drink
200 mL milk + 16 g maltodextrin
|
In a healthy male population, participants consumed a synbiotic test drink containing 200 mL milk + 16 g maltodextrin per day for 21 days with their habitual diet.
|
Active Comparator: Test drink
200 mL milk + 16 g inulin + Lactobacillus casei [>106 cfu/mL]
|
In a healthy male population, participants consumed a synbiotic test drink containing 200 mL milk + 16 g inulin + Lactobacillus casei431 [>106cfu/mL] per day for 21 days with their habitual diet.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in dietary energy and nutrient intakes by 3-day dietary record method
Time Frame: At the beginning and end of the intervention (Day 0 and Day 21)
|
Energy and nutrients intakes were assessed using a 3-day dietary record method at baseline (including the mean dietary intake of Day -3, Day -2 and Day -1) and at end of the intervention (including the mean dietary intake of Day 19, Day 20 and Day 21).
|
At the beginning and end of the intervention (Day 0 and Day 21)
|
Change in appetite sensations
Time Frame: 0., 30., 60., 90., 120. and 180. minutes at the beginning and end of the intervention (Day 0 and Day 21)
|
Appetite sensation was measured using 100-mm visual analog scale with a minimum value of 0 and a maximum value of 100 at six points including before the breakfast (0.) and following 30., 60., 90., 120.
and 180.
minutes.
Lower scores mean a better outcome.
|
0., 30., 60., 90., 120. and 180. minutes at the beginning and end of the intervention (Day 0 and Day 21)
|
Change in body weight
Time Frame: At the beginning and end of the intervention (Day 0 and Day 21)
|
Body weight was measured
|
At the beginning and end of the intervention (Day 0 and Day 21)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in area under the serum glucose concentration versus time curve (AUC)
Time Frame: 0., 30., 60. and 120. minutes at the beginning and end of the intervention (Day 0 and Day 21)
|
Serum glucose concentrations were measured at four point including before the breakfast (0.) and following 30., 60. and 120.
minutes to provide a curve.
|
0., 30., 60. and 120. minutes at the beginning and end of the intervention (Day 0 and Day 21)
|
Change in area under the serum insulin concentration versus time curve (AUC)
Time Frame: 0., 30., 60. and 120. minutes at the beginning and end of the intervention (Day 0 and Day 21)
|
Serum insulin concentrations were measured at four point including before the breakfast (0.) and following 30., 60. and 120.
minutes to provide a curve.
|
0., 30., 60. and 120. minutes at the beginning and end of the intervention (Day 0 and Day 21)
|
Change in area under the serum obestatin concentration versus time curve (AUC)
Time Frame: 0., 30., 60. and 120. minutes at the beginning and end of the intervention (Day 0 and Day 21)
|
Serum obestatin concentrations were measured at four point including before the breakfast (0.) and following 30., 60. and 120.
minutes to provide a curve.
|
0., 30., 60. and 120. minutes at the beginning and end of the intervention (Day 0 and Day 21)
|
Change in area under the serum ghrelin concentration versus time curve (AUC)
Time Frame: 0., 30., 60. and 120. minutes at the beginning and end of the intervention (Day 0 and Day 21)
|
Serum ghrelin concentrations were measured at four point including before the breakfast (0.) and following 30., 60. and 120.
minutes to provide a curve.
|
0., 30., 60. and 120. minutes at the beginning and end of the intervention (Day 0 and Day 21)
|
Change in area under the serum PYY concentration versus time curve (AUC)
Time Frame: 0., 30., 60. and 120. minutes at the beginning and end of the intervention (Day 0 and Day 21)
|
Serum PYY concentrations were measured at four point including before the breakfast (0.) and following 30., 60. and 120.
minutes to provide a curve.
|
0., 30., 60. and 120. minutes at the beginning and end of the intervention (Day 0 and Day 21)
|
Change in serum fasting adiponectin concentration
Time Frame: At the beginning and end of the intervention (Day 0 and Day 21)
|
Serum fasting adiponectin concentrations were measured at the beginning and end of the intervention
|
At the beginning and end of the intervention (Day 0 and Day 21)
|
Change in dietary energy and nutrient intakes by diet diary method
Time Frame: Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13, Day 14, Day 15, Day 16, Day 17, Day 18, Day 19, Day 20, Day 21
|
Energy and nutrients intakes were also assessed using diet diary method during 21-day intervention to confirm the changes assessed by 3-day dietary record.
|
Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13, Day 14, Day 15, Day 16, Day 17, Day 18, Day 19, Day 20, Day 21
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Zehra Buyuktuncer, PhD, Prof, Hacettepe University
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, 2016
Primary Completion (Actual)
July 5, 2018
Study Completion (Actual)
July 5, 2018
Study Registration Dates
First Submitted
December 19, 2019
First Submitted That Met QC Criteria
December 25, 2019
First Posted (Actual)
December 27, 2019
Study Record Updates
Last Update Posted (Actual)
December 27, 2019
Last Update Submitted That Met QC Criteria
December 25, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- THD-2017-15479
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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