AppetiteNCT07050017
Impact of Protein Content of Milk on Post-Exercise Appetite and Energy Intake
A study testing The study will investigate how different amounts of protein (0 g, 15 g, and 30 g) in post-exercise beverages affect appetite and energy intake following endurance exercise. in people with Appetite and Energy Intake, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the acute effects of consuming milk beverages with different protein content on subjective appetite and energy intake in healthy adults following endurance exercise. Read more about this study
- Who is it for?
- Ages 18 to 39 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Appetite, Energy Intake, Post-exercise
- What is being tested?
- The study will investigate how different amounts of protein (0 g, 15 g, and 30 g) in post-exercise beverages affect appetite and energy intake following endurance exercise.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 May 2025to 29 Sep 2025
- 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 18 to 39 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The study will include healthy, physically active male participants aged 18-39 years who have been engaging in recreational endurance sports (such as cycling, running, triathlon, orienteering, or team sports) for at least one year, with a minimum frequency of 3 sessions per week lasting 60-90 minutes.
Who cannot join
- Current smoker
- Chronic or excessive alcohol consumption
- Use of supplements and/or chronic medications that may affect appetite
- Presence of cardiac, hepatic, renal, pulmonary, neurological, hematological, gastrointestinal, diabetic, thyroid, or psychiatric disorders, and/or musculoskeletal conditions that may limit exercise participation
- Allergy or intolerance to any of the foods or beverages to be consumed during the study
- Unstable body weight (e.g., weight loss greater than 1 kg in the past week)
- Currently following a weight-loss diet
- Diagnosed eating disorders or individuals who cognitively restrict food intake (to be assessed using the Three-Factor Eating Questionnaire)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Milk Protein Content Reduces ad Libitum Post-exercise Energy Intake Without Altering Appetite in Active Males
This study aims to investigate the acute effects of consuming milk beverages with different protein content on subjective appetite and energy intake in healthy adults following endurance exercise. Participants will complete an endurance exercise protocol and then consume one of three beverages: a high-protein milk, a regular-protein milk, or an isoenergetic and isovolumetric carbohydrate control drink. Subjective appetite ratings will be assessed using visual analogue scales (VAS) at multiple time points after beverage consumption. Appetite-related hormonal responses, including insulin and acylated ghrelin, will be measured via blood samples. Energy intake will be assessed through an ad libitum test meal. This study will help determine whether different types of milk consumed post-exercise influence appetite regulation, hormonal response, and subsequent energy intake.
Read the detailed description
The primary objective of this randomized, double-blind, crossover clinical trial is to evaluate the acute effects of post-endurance exercise consumption of milk beverages with varying protein content on subjective appetite, circulating appetite-related hormones, and subsequent ad libitum energy intake in healthy, recreationally active adult males. The study will recruit at least 12 healthy male participants aged 18-39 years who have been regularly engaged in endurance-based physical activity (e.g., cycling, running, triathlon, orienteering, team sports) for a minimum of one year, with a training frequency of at least three sessions per week lasting 60-90 minutes each. Participants will complete five laboratory visits under a crossover design with a minimum one-week washout period between intervention conditions. The first two sessions will consist of pre-study visits (screening, anthropometric assessments, VO₂max testing, and familiarization). The remaining three visits will involve the ingestion of one of the following beverages in a randomized order: standard-protein milk (0 g protein), high-protein milk (30 g protein), or an isoenergetic carbohydrate-based control beverage (0 g protein). All beverages will be isocaloric and isovolumetric and provided in opaque bottles to ensure double-blind conditions. On each intervention day, participants will perform a steady-state endurance exercise protocol using a calibrated cycle ergometer, followed immediately by the ingestion of one of the test beverages. Appetite will be assessed subjectively using validated Visual Analogue Scales (VAS) at predefined intervals. Venous blood samples will be collected to analyze concentrations of insulin and acylated ghrelin as objective biomarkers of appetite regulation. One hour after beverage consumption, an ad libitum test meal will be provided to quantify subsequent energy intake. The total caloric intake and macronutrient distribution will be recorded and analyzed. This study is designed to provide insight into the role of post-exercise milk consumption-specifically the influence of protein content-on short-term appetite modulation and energy intake regulation in recreationally trained individuals.
- Conditions
- Appetite, Energy Intake, Post-exercise, Negative Energy Balance
- Being tested
- The study will investigate how different amounts of protein (0 g, 15 g, and 30 g) in post-exercise beverages affect appetite and energy intake following endurance exercise.
- Keywords
- milk, high-protein milk, protein, post-exercise, appetite, energy intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The study will investigate how different amounts of protein (0 g, 15 g, and 30 g) in post-exercise beverages affect appetite and energy intake following endurance exercise.Behavioural
The study will investigate how different amounts of protein (carbohydrate control drink : 0 g, reguler milk : 15 g, and high-protein milk : 30 g) in post-exercise beverages affect appetite and energy intake following endurance exercise.
| Study group | Role | What they receive |
|---|---|---|
| carbohydrate control drink: isoenergetic and isovolumetric with milk beverages. | Active comparator | Isoenergetic and isovolumetric with milk beverages Receives: Behavioral: The study will investigate how different amounts of protein (0 g, 15 g, and 30 g) in post-exercise beverages affect appetite and energy intake following endurance exercise. |
| regular milk | Experimental | containing 15 g protein Receives: Behavioral: The study will investigate how different amounts of protein (0 g, 15 g, and 30 g) in post-exercise beverages affect appetite and energy intake following endurance exercise. |
| high-protein milk | Experimental | containing 30 g protein Receives: Behavioral: The study will investigate how different amounts of protein (0 g, 15 g, and 30 g) in post-exercise beverages affect appetite and energy intake following endurance exercise. |
What is being measured
The primary outcome is the main question the study is designed to answer.
energy intake
Energy intake will be measured through an ad libitum meal provided after the exercise.
Measured: From enrollment to the end of treatment at 3 weeks.
Secondary outcomes (3)
acylated ghrelin (pg/mL)
Plasma acyl ghrelin will be measured as an indicator of appetite.
Measured: From enrollment to the end of treatment at 3 weeks.
Insulin (pmol/L)
Plasma insulin will be measured as an indicator of appetite and glucose metabolism.
Measured: From enrollment to the end of treatment at 3 weeks.
subjective appetite
Subjective appetite will be assessed using Visual Analogue Scales (mm).
Measured: From enrollment to the end of treatment at 3 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start29 May 2025
- Primary completion29 Jul 2025
- Study completion29 Sep 2025
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
- Crossover
- Model description
- All participants will attend 5 visits. Two of them are pre-screening visits.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Tunçil, Hacettepe University
- Investigators
- muhammed atakan, Associate Professor, Study chair, Hacettepe Universityzeynep ergün, PHD student, Study chair, Hacettepe Universitysüleyman bulut, Associate Professor, Study chair, Hacettepe Universityhüsrev turnagöl, professor, Study chair, Hacettepe Universitytahir hazır, professor, Study chair, Hacettepe Universityyiğitcan karanfil, Assistant professor, Study chair, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07050017
- Sponsor's protocol ID
- SBF-25-059
- Status last verified
- Oct 2025
- First submitted
- 17 Jun 2025
- Last updated
- 6 Oct 2025
- 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 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Milk Protein Content Reduces ad Libitum Post-exercise Energy Intake Without Altering Appetite in Active Males
- ClinicalTrials.gov ID
- NCT07050017
- Acronym / sponsor ID
- SBF-25-059
- Conditions
- Appetite, Energy Intake, Post-exercise, Negative Energy Balance
- Keywords
- milk, high-protein milk, protein, post-exercise, appetite, energy intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 29 May 2025 (actual)
- Primary completion
- 29 Jul 2025 (actual)
- Study completion
- 29 Sep 2025 (actual)
- First posted
- 3 Jul 2025 (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.
This study aims to investigate the acute effects of consuming milk beverages with different protein content on subjective appetite and energy intake in healthy adults following endurance exercise. Participants will complete an endurance exercise protocol and then consume one of three beverages: a high-protein milk, a regular-protein milk, or an isoenergetic and isovolumetric carbohydrate control drink. Subjective appetite ratings will be assessed using visual analogue scales (VAS) at multiple time points after beverage consumption. Appetite-related hormonal responses, including insulin and acylated ghrelin, will be measured via blood samples. Energy intake will be assessed through an ad libitum test meal. This study will help determine whether different types of milk consumed post-exercise influence appetite regulation, hormonal response, and subsequent energy intake.
Detailed description
The primary objective of this randomized, double-blind, crossover clinical trial is to evaluate the acute effects of post-endurance exercise consumption of milk beverages with varying protein content on subjective appetite, circulating appetite-related hormones, and subsequent ad libitum energy intake in healthy, recreationally active adult males. The study will recruit at least 12 healthy male participants aged 18-39 years who have been regularly engaged in endurance-based physical activity (e.g., cycling, running, triathlon, orienteering, team sports) for a minimum of one year, with a training frequency of at least three sessions per week lasting 60-90 minutes each. Participants will complete five laboratory visits under a crossover design with a minimum one-week washout period between intervention conditions. The first two sessions will consist of pre-study visits (screening, anthropometric assessments, VO₂max testing, and familiarization). The remaining three visits will involve the ingestion of one of the following beverages in a randomized order: standard-protein milk (0 g protein), high-protein milk (30 g protein), or an isoenergetic carbohydrate-based control beverage (0 g protein). All beverages will be isocaloric and isovolumetric and provided in opaque bottles to ensure double-blind conditions. On each intervention day, participants will perform a steady-state endurance exercise protocol using a calibrated cycle ergometer, followed immediately by the ingestion of one of the test beverages. Appetite will be assessed subjectively using validated Visual Analogue Scales (VAS) at predefined intervals. Venous blood samples will be collected to analyze concentrations of insulin and acylated ghrelin as objective biomarkers of appetite regulation. One hour after beverage consumption, an ad libitum test meal will be provided to quantify subsequent energy intake. The total caloric intake and macronutrient distribution will be recorded and analyzed. This study is designed to provide insight into the role of post-exercise milk consumption-specifically the influence of protein content-on short-term appetite modulation and energy intake regulation in recreationally trained individuals.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- All participants will attend 5 visits. Two of them are pre-screening visits.
| Arm | Type | Receives |
|---|---|---|
| carbohydrate control drink: isoenergetic and isovolumetric with milk beverages. | Active comparator | Behavioral: The study will investigate how different amounts of protein (0 g, 15 g, and 30 g) in post-exercise beverages affect appetite and energy intake following endurance exercise.Isoenergetic and isovolumetric with milk beverages |
| regular milk | Experimental | Behavioral: The study will investigate how different amounts of protein (0 g, 15 g, and 30 g) in post-exercise beverages affect appetite and energy intake following endurance exercise.containing 15 g protein |
| high-protein milk | Experimental | Behavioral: The study will investigate how different amounts of protein (0 g, 15 g, and 30 g) in post-exercise beverages affect appetite and energy intake following endurance exercise.containing 30 g protein |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The study will include healthy, physically active male participants aged 18-39 years who have been engaging in recreational endurance sports (such as cycling, running, triathlon, orienteering, or team sports) for at least one year, with a minimum frequency of 3 sessions per week lasting 60-90 minutes.
Key exclusion criteria (8 listed)
- Current smoker
- Chronic or excessive alcohol consumption
- Use of supplements and/or chronic medications that may affect appetite
- Presence of cardiac, hepatic, renal, pulmonary, neurological, hematological, gastrointestinal, diabetic, thyroid, or psychiatric disorders, and/or musculoskeletal conditions that may limit exercise participation
- Allergy or intolerance to any of the foods or beverages to be consumed during the study
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 |
|---|---|---|
| The study will investigate how different amounts of protein (0 g, 15 g, and 30 g) in post-exercise beverages affect appetite and energy intake following endurance exercise.The study will investigate how different amounts of protein (carbohydrate control drink : 0 g, reguler milk : 15 g, and high-protein milk : 30 g) in post-exercise beverages affect appetite and energy intake following endurance exercise. | Behavioural | carbohydrate control drink: isoenergetic and isovolumetric with milk beverages., high-protein milk, regular milk |
Primary outcome
energy intake
Time frame: From enrollment to the end of treatment at 3 weeks.
Energy intake will be measured through an ad libitum meal provided after the exercise.
3 secondary outcomes
acylated ghrelin (pg/mL)
Time frame: From enrollment to the end of treatment at 3 weeks.
Insulin (pmol/L)
Time frame: From enrollment to the end of treatment at 3 weeks.
subjective appetite
Time frame: From enrollment to the end of treatment at 3 weeks.
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 6 Oct 2025.
- 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.
muhammed atakan, Associate Professor study chair
Hacettepe University
zeynep ergün, PHD student study chair
Hacettepe University
süleyman bulut, Associate Professor study chair
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 The study will investigate how different amounts of protein (0 g, 15 g, and 30 g) in post-exercise beverages affect appetite and energy intake following endurance exercise. in people with Appetite and Energy 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 1 inclusion and 8 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 6 Oct 2025. 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. 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?
energy intake (time frame: From enrollment to the end of treatment at 3 weeks.). 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 6 Oct 2025.