MetabolismEarly Phase 1NCT06250270
Effects of Casein Protein on Metabolism When Taken Prior to Sleep and in the Morning
A Early Phase 1 study of Metabolism, run by Ohio University at 1 site in United States.
Trial summary
The purpose of this study is to investigate the effect of casein protein consumption both prior to sleep as well first thing in the morning on metabolism (increase satiety and appetite, lower resting metabolic rate, and lower blood sugar levels), when compared to nighttime protein or placebo consumption alone. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolism
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2022to 31 Dec 2025
- Phase
- Early Phase 1
- 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male
- aged 18-30
Who cannot join
- lactose intolerant
- having known sleep issues
- being on a schedule that is not uniform week to week
- those who do not eat animal-based diets
- any known or suspected food allergies
- any known health conditions (cardiovascular disease, IBS, high blood pressure, diabetes, crohn's disease)
Show all 9Show fewer
- those that have disordered eating
- unwillingness to take blood sugar four times a day
- being a female
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio University Exercise Physiology Lab
Athens, Ohio, 45701
About this study
The purpose of this study is to investigate the effect of casein protein consumption both prior to sleep as well first thing in the morning on metabolism (increase satiety and appetite, lower resting metabolic rate, and lower blood sugar levels), when compared to nighttime protein or placebo consumption alone. Protein itself is a macronutrient that not only helps the body repair itself, and play a critical role in growth, it also aids in increasing satiety and decreasing appetite. Casein protein specifically is slow digesting dairy protein which may impact the body's metabolism for a longer period than other dairy proteins such as whey. The literature demonstrates nighttime protein ingestion prior to sleep increases metabolic rate and satiety the next morning. However, there appears to be no data on the metabolic effects of protein ingested both at night and in the morning.
- Conditions
- Metabolism
- Being tested
- protein or placebo
- Keywords
- Metabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protein or placeboDietary supplement
casein protein (30g) or placebo (maltodextrin, 30g)
| Study group | Role | What they receive |
|---|---|---|
| PRO pm, PRO am | Experimental | Participants arrive to the lab, complete 30 mins resting metabolic rate assessment. Then they are provided with a shake to drink 30 mins before bed. They return to the lab the following morning for 30 min RMR, drink another shake and do 30 mins RMR before leaving the lab. Receives: Dietary Supplement: protein or placebo |
| PRO pm, PLAC am | Experimental | Participants arrive to the lab, complete 30 mins resting metabolic rate assessment. Then they are provided with a shake to drink 30 mins before bed. They return to the lab the following morning for 30 min RMR, drink another shake and do 30 mins RMR before leaving the lab. Receives: Dietary Supplement: protein or placebo |
| PLAC pm, PRO am | Experimental | Participants arrive to the lab, complete 30 mins resting metabolic rate assessment. Then they are provided with a shake to drink 30 mins before bed. They return to the lab the following morning for 30 min RMR, drink another shake and do 30 mins RMR before leaving the lab. Receives: Dietary Supplement: protein or placebo |
| PLAC pm, PLAC pm | Placebo comparator | Participants arrive to the lab, complete 30 mins resting metabolic rate assessment. Then they are provided with a shake to drink 30 mins before bed. They return to the lab the following morning for 30 min RMR, drink another shake and do 30 mins RMR before leaving the lab. Receives: Dietary Supplement: protein or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
resting metabolic rate
indirect calorimetry to measure oxygen consumption (V02) and respiratory quotient (RQ)
Measured: baseline, during the intervention
blood glucose
fasting and pre-meal blood glucose
Measured: baseline, during the intervention
Secondary outcomes (1)
dietary intake
food logs used to track food intake during all trial visits
Measured: during the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start1 Oct 2022
- Primary completion1 May 2024
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetabolismStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Hillman, Ohio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250270
- Sponsor's protocol ID
- 22-F-7
- Status last verified
- Oct 2026
- First submitted
- 31 Jan 2024
- Last updated
- 23 Oct 2026
- 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 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Casein Protein on Metabolism When Taken Prior to Sleep and in the Morning
- ClinicalTrials.gov ID
- NCT06250270
- Acronym / sponsor ID
- 22-F-7
- Conditions
- Metabolism
- Keywords
- Metabolism
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Ohio UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 9 Feb 2024 (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.
The purpose of this study is to investigate the effect of casein protein consumption both prior to sleep as well first thing in the morning on metabolism (increase satiety and appetite, lower resting metabolic rate, and lower blood sugar levels), when compared to nighttime protein or placebo consumption alone. Protein itself is a macronutrient that not only helps the body repair itself, and play a critical role in growth, it also aids in increasing satiety and decreasing appetite. Casein protein specifically is slow digesting dairy protein which may impact the body's metabolism for a longer period than other dairy proteins such as whey. The literature demonstrates nighttime protein ingestion prior to sleep increases metabolic rate and satiety the next morning. However, there appears to be no data on the metabolic effects of protein ingested both at night and in the morning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PRO pm, PRO am | Experimental | Dietary Supplement: protein or placeboParticipants arrive to the lab, complete 30 mins resting metabolic rate assessment. Then they are provided with a shake to drink 30 mins before bed. They return to the lab the following morning for 30 min RMR, drink another shake and do 30 mins RMR before leaving the lab. |
| PRO pm, PLAC am | Experimental | Dietary Supplement: protein or placeboParticipants arrive to the lab, complete 30 mins resting metabolic rate assessment. Then they are provided with a shake to drink 30 mins before bed. They return to the lab the following morning for 30 min RMR, drink another shake and do 30 mins RMR before leaving the lab. |
| PLAC pm, PRO am | Experimental | Dietary Supplement: protein or placeboParticipants arrive to the lab, complete 30 mins resting metabolic rate assessment. Then they are provided with a shake to drink 30 mins before bed. They return to the lab the following morning for 30 min RMR, drink another shake and do 30 mins RMR before leaving the lab. |
| PLAC pm, PLAC pm | Placebo comparator | Dietary Supplement: protein or placeboParticipants arrive to the lab, complete 30 mins resting metabolic rate assessment. Then they are provided with a shake to drink 30 mins before bed. They return to the lab the following morning for 30 min RMR, drink another shake and do 30 mins RMR before leaving the lab. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- male
- aged 18-30
Key exclusion criteria (9 listed)
- lactose intolerant
- having known sleep issues
- being on a schedule that is not uniform week to week
- those who do not eat animal-based diets
- any known or suspected food allergies
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 |
|---|---|---|
| protein or placebocasein protein (30g) or placebo (maltodextrin, 30g) | Dietary supplement | PLAC pm, PLAC pm, PLAC pm, PRO am, PRO pm, PLAC am, PRO pm, PRO am |
Primary outcome
resting metabolic rate
Time frame: baseline, during the intervention
indirect calorimetry to measure oxygen consumption (V02) and respiratory quotient (RQ)
blood glucose
Time frame: baseline, during the intervention
fasting and pre-meal blood glucose
1 secondary outcome
dietary intake
Time frame: during the intervention
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 23 Oct 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study of Metabolism, run by Ohio University at 1 site in United States.
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 2 inclusion and 9 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 23 Oct 2026. 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 United States. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
resting metabolic rate (time frame: baseline, during the intervention). The study lists 2 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 23 Oct 2026.