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

Not Applicable

Completed

• Conditions: Body Weight; Appetite; Dietary Intake
• Interventions: Other: Control drink; Other: Synbiotic test drink

• Registration Number: NCT04212546
• Lead Sponsor: Hacettepe University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2018-07-05
• Study Completion: 2018-07-05
• Status Verified: 2019-12
• Study First Submitted: 2019-12-19
• Study First Submitted QC: 2019-12-25
• Last Update Submitted: 2019-12-25
• Study First Posted: 2019-12-27
• Last Update Posted: 2019-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 21

Inclusion Criteria

• Healthy male
• 19-30 years old
• Body mass index (BMI) of 18.5-29.9 kg/m2

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control drink	Control drink	200 mL milk + 16 g maltodextrin
Test drink	Synbiotic test drink	200 mL milk + 16 g inulin + Lactobacillus casei \[\>106 cfu/mL\]

Primary Outcome Measures

Name	Time	Method
Change in dietary energy and nutrient intakes by 3-day dietary record method	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).
Change in appetite sensations	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.
Change in body weight	At the beginning and end of the intervention (Day 0 and Day 21)	Body weight was measured

Secondary Outcome Measures

Name	Time	Method
Change in area under the serum glucose concentration versus time curve (AUC)	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.
Change in area under the serum insulin concentration versus time curve (AUC)	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.
Change in area under the serum obestatin concentration versus time curve (AUC)	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.
Change in area under the serum ghrelin concentration versus time curve (AUC)	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.
Change in area under the serum PYY concentration versus time curve (AUC)	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.
Change in serum fasting adiponectin concentration	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
Change in dietary energy and nutrient intakes by diet diary method	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.

Trial Locations

Locations (1)

Hacettepe University, Faculty of Health Sciences, Department of Nutrition and Dietetics; 🇹🇷 Ankara, Turkey