Short and Long-Term Effects of Prebiotic, Probiotic and Synbiotic on Appetite and Dietary Intake

Study Overview
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Brief Summary
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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.

Official Title
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Short and Long-Term Effects of Prebiotic, Probiotic and Synbiotic on Appetite and Dietary Intake

Conditions
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Appetite, Dietary Intake, Body Weight

Intervention / Treatment
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* Other: Synbiotic test drink
* Other: Control drink


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control drink<br>200 mL milk + 16 g maltodextrin | Other: Control drink<br>* 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.<br>|
| Active Comparator: Test drink<br>200 mL milk + 16 g inulin + Lactobacillus casei [>106 cfu/mL] | Other: Synbiotic test drink<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | At the beginning and end of the intervention (Day 0 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. | 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 | 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) | 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) | 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) | 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) | 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) | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prebiotic, probiotic, synbiotic, hunger and satiety hormones