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

NCT ID: NCT04212546

Last Updated: 2019-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2018-07-05

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.

Detailed Description

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Conditions

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Appetite Dietary Intake Body Weight

Keywords

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prebiotic probiotic synbiotic hunger and satiety hormones

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Triple (Participant, Investigator, Outcomes Assessor)

Study Groups

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Control drink

200 mL milk + 16 g maltodextrin

Group Type PLACEBO_COMPARATOR

Control drink

Intervention Type 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.

Test drink

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

Group Type ACTIVE_COMPARATOR

Synbiotic test drink

Intervention Type 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.

Interventions

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Synbiotic test drink

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

Control drink

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.

Intervention Type OTHER

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)
Minimum Eligible Age

19 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ankara University

OTHER

Sponsor Role collaborator

Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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ZEHRA BUYUKTUNCER

Professor in Nutrition and Dietetics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zehra Buyuktuncer, PhD, Prof

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Locations

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

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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THD-2017-15479

Identifier Type: -

Identifier Source: org_study_id