Clinical trial NCT04212546: 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
Overall status: COMPLETED
Phase: NA
Conditions: Appetite
Dietary Intake
Body Weight
Keywords: prebiotic
probiotic
synbiotic
hunger and satiety hormones
Lead sponsor: Hacettepe University
Sponsor class: OTHER
Collaborators: name: Ankara University
First posted: 2019-12-27
Enrollment: 21
Sex: MALE
Minimum age (years): 19
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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.


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)

Primary outcomes:
measure: Change in dietary energy and nutrient intakes by 3-day dietary record method
timeFrame: At the beginning and end of the intervention (Day 0 and Day 21)
measure: Change in appetite sensations
timeFrame: 0., 30., 60., 90., 120. and 180. minutes at the beginning and end of the intervention (Day 0 and Day 21)
measure: Change in body weight
timeFrame: At the beginning and end of the intervention (Day 0 and Day 21)
Secondary outcomes:
measure: Change in area under the serum glucose concentration versus time curve (AUC)
timeFrame: 0., 30., 60. and 120. minutes at the beginning and end of the intervention (Day 0 and Day 21)
measure: Change in area under the serum insulin concentration versus time curve (AUC)
timeFrame: 0., 30., 60. and 120. minutes at the beginning and end of the intervention (Day 0 and Day 21)
measure: Change in area under the serum obestatin concentration versus time curve (AUC)
timeFrame: 0., 30., 60. and 120. minutes at the beginning and end of the intervention (Day 0 and Day 21)
measure: Change in area under the serum ghrelin concentration versus time curve (AUC)
timeFrame: 0., 30., 60. and 120. minutes at the beginning and end of the intervention (Day 0 and Day 21)
measure: Change in area under the serum PYY concentration versus time curve (AUC)
timeFrame: 0., 30., 60. and 120. minutes at the beginning and end of the intervention (Day 0 and Day 21)
measure: Change in serum fasting adiponectin concentration
timeFrame: At the beginning and end of the intervention (Day 0 and Day 21)
measure: Change in dietary energy and nutrient intakes by diet diary method
timeFrame: 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
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University, Faculty of Health Sciences, Department of Nutrition and Dietetics
Study officials:
affiliation: Hacettepe University
name: Zehra Buyuktuncer, PhD, Prof
role: PRINCIPAL_INVESTIGATOR
References: