← Back to Search

PRO pm, PLAC am for Metabolism

Phase 1

Recruiting

Research Sponsored by Ohio University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male

Aged 18-30

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, during the intervention

Awards & highlights

Study Summary

This trial investigates how consuming casein protein before sleep and in the morning affects metabolism compared to consuming protein only at night or a placebo. Protein helps repair the body, promotes growth, and can make you

Who is the study for?

This trial is for individuals interested in understanding how casein protein affects their metabolism. Participants should be willing to consume casein protein before sleep and in the morning, or a placebo, to compare effects on satiety, metabolic rate, and blood sugar levels.Check my eligibility

What is being tested?

The study tests the impact of consuming casein protein at two different times: before sleeping and upon waking up. It aims to see if this regimen can increase fullness, lower hunger, boost resting metabolism, and reduce blood sugar compared to taking nighttime protein or a placebo alone.See study design

What are the potential side effects?

Casein is generally considered safe but may cause digestive discomfort such as bloating or gas in some people. Those with dairy allergies could experience allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am male.

Select...

I am between 18 and 30 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during the intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during the intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and during the intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

blood glucose

resting metabolic rate

Secondary outcome measures

dietary intake

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: PRO pm, PRO amExperimental Treatment1 Intervention

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.

Group II: PRO pm, PLAC amExperimental Treatment1 Intervention

Group III: PLAC pm, PRO amExperimental Treatment1 Intervention

Group IV: PLAC pm, PLAC pmPlacebo Group1 Intervention

0 / 2Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Ohio UniversityLead Sponsor

69 Previous Clinical Trials

37,199 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals being recruited for participation in this research study?

"Indeed, the details on clinicaltrials.gov affirm that this research endeavor is presently seeking volunteers. The trial was originally disclosed on October 1st, 2022, with the most recent update made on February 7th, 2024. A total of 15 participants are sought from a single designated site."

Answered by AI

Are individuals younger than 25 years permitted to participate in this investigation?

"Individuals aged between 18 and 30 are eligible for participation in this research endeavor. There are also separate trials available specifically tailored to patients under 18 years old as well as those over the age of 65, with a total of 3 and 9 respective studies catering to these demographics."

Answered by AI

Are there any available slots for patients to participate in this clinical trial?

"Affirmative. Information from clinicaltrials.gov indicates that patient recruitment is ongoing for this trial. The study was initially posted on October 1, 2022 and last updated on February 7, 2024. This investigation aims to enroll 15 participants at a single site."

Answered by AI

Has the FDA officially approved PRO pm, PLAC am for use?

"Based on our evaluation at Power, the safety rating for PRO pm, PLAC am is graded as 1 due to its Phase 1 trial status, indicating minimal available data supporting both safety and effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effects of Casein Protein on Metabolism When Taken Prior to Sleep and in the Morning

Angela Hillman 2022. "Effects of Casein Protein on Metabolism When Taken Prior to Sleep and in the Morning". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06250270.