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CompletedNCT04212546

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
21 (actual)
Sponsor
Hacettepe University · Academic / Other
Sex
Male
Age
19 Years – 30 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
OTHERSynbiotic test drinkIn 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.
OTHERControl drinkIn 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.

Timeline

Start date
2016-01-01
Primary completion
2018-07-05
Completion
2018-07-05
First posted
2019-12-27
Last updated
2019-12-27

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT04212546. Inclusion in this directory is not an endorsement.

Short and Long-Term Effects of Prebiotic, Probiotic and Synbiotic on Appetite and Dietary Intake (NCT04212546) · Clinical Trials Directory