AppetiteNCT04212546
Short and Long-Term Effects of Prebiotic, Probiotic and Synbiotic on Appetite and Dietary Intake
A study testing Synbiotic test drink in people with Appetite and Dietary Intake, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Appetite, Dietary Intake, Body Weight
- What is being tested?
- Synbiotic test drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2016to 5 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male
- 19-30 years old
- Body mass index (BMI) of 18.5-29.9 kg/m2
Who cannot join
- 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
Show all 14Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University, Faculty of Health Sciences, Department of Nutrition and Dietetics
Ankara, 06230
About this study
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
- Being tested
- Synbiotic test drink, Control drink
- Keywords
- prebiotic, probiotic, synbiotic, hunger and satiety hormones
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synbiotic test drinkOther
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 drinkOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control drink | Placebo comparator | 200 mL milk + 16 g maltodextrin Receives: Other: Control drink |
| Test drink | Active comparator | 200 mL milk + 16 g inulin + Lactobacillus casei [>106 cfu/mL] Receives: Other: Synbiotic test drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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
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)
Serum glucose concentrations were measured at four point including before the breakfast (0.) and following 30., 60. and 120. minutes to provide a curve.
Measured: 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)
Serum insulin concentrations were measured at four point including before the breakfast (0.) and following 30., 60. and 120. minutes to provide a curve.
Measured: 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)
Serum obestatin concentrations were measured at four point including before the breakfast (0.) and following 30., 60. and 120. minutes to provide a curve.
Measured: 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)
Serum ghrelin concentrations were measured at four point including before the breakfast (0.) and following 30., 60. and 120. minutes to provide a curve.
Measured: 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)
Serum PYY concentrations were measured at four point including before the breakfast (0.) and following 30., 60. and 120. minutes to provide a curve.
Measured: 0., 30., 60. and 120. minutes at the beginning and end of the intervention (Day 0 and Day 21)
Change in serum fasting adiponectin concentration
Serum fasting adiponectin concentrations were measured at the beginning and end of the intervention
Measured: At the beginning and end of the intervention (Day 0 and Day 21)
Change in dietary energy and nutrient intakes by diet diary method
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2019
- Study start1 Jan 2016
- Primary completion5 Jul 2018
- Study completion5 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AppetiteStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara University
- Responsible party
- Principal investigator, ZEHRA BUYUKTUNCER, Hacettepe University
- Investigators
- Zehra Buyuktuncer, PhD, Prof, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04212546
- Sponsor's protocol ID
- THD-2017-15479
- Status last verified
- Dec 2019
- First submitted
- 19 Dec 2019
- Last updated
- 27 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short and Long-Term Effects of Prebiotic, Probiotic and Synbiotic on Appetite and Dietary Intake
- ClinicalTrials.gov ID
- NCT04212546
- Acronym / sponsor ID
- THD-2017-15479
- Conditions
- Appetite, Dietary Intake, Body Weight
- Keywords
- prebiotic, probiotic, synbiotic, hunger and satiety hormones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Ankara University
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 5 Jul 2018 (actual)
- Study completion
- 5 Jul 2018 (actual)
- First posted
- 27 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control drink | Placebo comparator | Other: Control drink200 mL milk + 16 g maltodextrin |
| Test drink | Active comparator | Other: Synbiotic test drink200 mL milk + 16 g inulin + Lactobacillus casei [>106 cfu/mL] |
Who may qualify
- Ages
- 19 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male
- 19-30 years old
- Body mass index (BMI) of 18.5-29.9 kg/m2
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Synbiotic 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. | Other | Test drink |
| Control 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. | Other | Control drink |
Primary outcome
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).
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.
Change in body weight
Time frame: At the beginning and end of the intervention (Day 0 and Day 21)
Body weight was measured
7 secondary outcomes
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)
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)
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)
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)
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)
Change in serum fasting adiponectin concentration
Time frame: At the beginning and end of the intervention (Day 0 and Day 21)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zehra Buyuktuncer, PhD, Prof principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synbiotic test drink in people with Appetite and Dietary Intake, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2019.