Short and Long-Term Effects of Prebiotic, Probiotic and Synbiotic on Appetite and Dietary Intake
Primary Purpose
Appetite, Dietary Intake, Body Weight
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Synbiotic test drink
Control drink
Sponsored by
About this trial
This is an interventional other trial for Appetite focused on measuring prebiotic, probiotic, synbiotic, hunger and satiety hormones
Eligibility Criteria
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)
Sites / Locations
- Hacettepe University, Faculty of Health Sciences, Department of Nutrition and Dietetics
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Control drink
Test drink
Arm Description
200 mL milk + 16 g maltodextrin
200 mL milk + 16 g inulin + Lactobacillus casei [>106 cfu/mL]
Outcomes
Primary Outcome Measures
Change in dietary energy and nutrient intakes by 3-day dietary record method
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).
Change in appetite sensations
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.
Change in body weight
Body weight was measured
Secondary Outcome Measures
Change in area under the serum glucose concentration versus time curve (AUC)
Serum glucose concentrations were measured at four point including before the breakfast (0.) and following 30., 60. and 120. minutes to provide a curve.
Change in area under the serum insulin concentration versus time curve (AUC)
Serum insulin concentrations were measured at four point including before the breakfast (0.) and following 30., 60. and 120. minutes to provide a curve.
Change in area under the serum obestatin concentration versus time curve (AUC)
Serum obestatin concentrations were measured at four point including before the breakfast (0.) and following 30., 60. and 120. minutes to provide a curve.
Change in area under the serum ghrelin concentration versus time curve (AUC)
Serum ghrelin concentrations were measured at four point including before the breakfast (0.) and following 30., 60. and 120. minutes to provide a curve.
Change in area under the serum PYY concentration versus time curve (AUC)
Serum PYY concentrations were measured at four point including before the breakfast (0.) and following 30., 60. and 120. minutes to provide a curve.
Change in serum fasting adiponectin concentration
Serum fasting adiponectin concentrations were measured at the beginning and end of the intervention
Change in dietary energy and nutrient intakes by diet diary method
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.
Full Information
NCT ID
NCT04212546
First Posted
December 19, 2019
Last Updated
December 25, 2019
Sponsor
Hacettepe University
Collaborators
Ankara University
1. Study Identification
Unique Protocol Identification Number
NCT04212546
Brief Title
Short and Long-Term Effects of Prebiotic, Probiotic and Synbiotic on Appetite and Dietary Intake
Official Title
Short and Long-Term Effects of Prebiotic, Probiotic and Synbiotic on Appetite and Dietary Intake
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
July 5, 2018 (Actual)
Study Completion Date
July 5, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
Collaborators
Ankara University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appetite, Dietary Intake, Body Weight
Keywords
prebiotic, probiotic, synbiotic, hunger and satiety hormones
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study has two phases. First phase had a randomised, double blind, placebo-controlled crossover study design.
The second phase had a randomized, double-blind, placebo-controlled parallel study design. The second phase is going to be described below.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Triple (Participant, Investigator, Outcomes Assessor)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control drink
Arm Type
Placebo Comparator
Arm Description
200 mL milk + 16 g maltodextrin
Arm Title
Test drink
Arm Type
Active Comparator
Arm Description
200 mL milk + 16 g inulin + Lactobacillus casei [>106 cfu/mL]
Intervention Type
Other
Intervention Name(s)
Synbiotic test drink
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control drink
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in dietary energy and nutrient intakes by 3-day dietary record method
Description
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).
Time Frame
At the beginning and end of the intervention (Day 0 and Day 21)
Title
Change in appetite sensations
Description
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.
Time Frame
0., 30., 60., 90., 120. and 180. minutes at the beginning and end of the intervention (Day 0 and Day 21)
Title
Change in body weight
Description
Body weight was measured
Time Frame
At the beginning and end of the intervention (Day 0 and Day 21)
Secondary Outcome Measure Information:
Title
Change in area under the serum glucose concentration versus time curve (AUC)
Description
Serum glucose concentrations were measured at four point including before the breakfast (0.) and following 30., 60. and 120. minutes to provide a curve.
Time Frame
0., 30., 60. and 120. minutes at the beginning and end of the intervention (Day 0 and Day 21)
Title
Change in area under the serum insulin concentration versus time curve (AUC)
Description
Serum insulin concentrations were measured at four point including before the breakfast (0.) and following 30., 60. and 120. minutes to provide a curve.
Time Frame
0., 30., 60. and 120. minutes at the beginning and end of the intervention (Day 0 and Day 21)
Title
Change in area under the serum obestatin concentration versus time curve (AUC)
Description
Serum obestatin concentrations were measured at four point including before the breakfast (0.) and following 30., 60. and 120. minutes to provide a curve.
Time Frame
0., 30., 60. and 120. minutes at the beginning and end of the intervention (Day 0 and Day 21)
Title
Change in area under the serum ghrelin concentration versus time curve (AUC)
Description
Serum ghrelin concentrations were measured at four point including before the breakfast (0.) and following 30., 60. and 120. minutes to provide a curve.
Time Frame
0., 30., 60. and 120. minutes at the beginning and end of the intervention (Day 0 and Day 21)
Title
Change in area under the serum PYY concentration versus time curve (AUC)
Description
Serum PYY concentrations were measured at four point including before the breakfast (0.) and following 30., 60. and 120. minutes to provide a curve.
Time Frame
0., 30., 60. and 120. minutes at the beginning and end of the intervention (Day 0 and Day 21)
Title
Change in serum fasting adiponectin concentration
Description
Serum fasting adiponectin concentrations were measured at the beginning and end of the intervention
Time Frame
At the beginning and end of the intervention (Day 0 and Day 21)
Title
Change in dietary energy and nutrient intakes by diet diary method
Description
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.
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zehra Buyuktuncer, PhD, Prof
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hacettepe University, Faculty of Health Sciences, Department of Nutrition and Dietetics
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Short and Long-Term Effects of Prebiotic, Probiotic and Synbiotic on Appetite and Dietary Intake
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