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Completed

NCT Number: NCT04212546

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

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.

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Key information

Conditions

Appetite Body Weight Dietary Intake Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

Ankara, 06230, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in dietary energy and nutrient intakes by 3-day dietary record method

    Time frame: 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).

  2. Change in appetite sensations

    Time frame: 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.

  3. Change in body weight

    Time frame: At the beginning and end of the intervention (Day 0 and Day 21)

    Body weight was measured

Secondary outcomes

  1. Change in area under the serum glucose concentration versus time curve (AUC)

    Time frame: 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.

  2. Change in area under the serum insulin concentration versus time curve (AUC)

    Time frame: 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.

  3. Change in area under the serum obestatin concentration versus time curve (AUC)

    Time frame: 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.

  4. Change in area under the serum ghrelin concentration versus time curve (AUC)

    Time frame: 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.

  5. Change in area under the serum PYY concentration versus time curve (AUC)

    Time frame: 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.

  6. Change in serum fasting adiponectin concentration

    Time frame: 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

  7. Change in dietary energy and nutrient intakes by diet diary method

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Collaborators

  • Ankara University

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 27, 2019
Registry last updated
Dec 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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