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

NCT04212546 | Completed

• 1 other identifier: THD-2017-15479
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Appetite; Dietary Intake; Body Weight

Keywords

prebiotic; probiotic; synbiotic; hunger and satiety hormones

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

Control drink

PLACEBO COMPARATOR

200 mL milk + 16 g maltodextrin

Other: Control drink

Test drink

ACTIVE COMPARATOR

200 mL milk + 16 g inulin + Lactobacillus casei \[\>106 cfu/mL\]

Other: Synbiotic test drink

Interventions

Synbiotic test drink OTHER

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.

Test drink

Control drink OTHER

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.

Control drink

Eligibility Criteria

• Age: 19 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hacettepe University: lead
• Ankara University: collaborator

Study Sites (1)

Hacettepe University, Faculty of Health Sciences, Department of Nutrition and Dietetics

Ankara, 06230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Body Weight

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zehra Buyuktuncer, PhD, Prof

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple (Participant, Investigator, Outcomes Assessor)
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Nutrition and Dietetics

Model Details: 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.

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: December 27, 2019
• Study Start: January 1, 2016
• Primary Completion: July 5, 2018
• Study Completion: July 5, 2018
• Last Updated: December 27, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)