Casein Protein for Metabolism

Age: 18 - 65

Sex: Male

Trial Phase: Phase < 1

Sponsor: Ohio University

Disqualifiers: Lactose intolerant, Sleep issues, Non-uniform schedule, Animal-free diet, Food allergies, Health conditions, others

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how consuming casein protein, a slow-digesting dairy protein, affects metabolism when taken before bed and in the morning. Researchers aim to determine if this approach can better control appetite, improve feelings of fullness, and manage blood sugar levels compared to protein consumed only at night or a placebo. Participants will be divided into groups to try different combinations of casein and placebo shakes to assess these effects. Men aged 18-30 who are not lactose intolerant and have a consistent weekly schedule may be suitable candidates. As an Early Phase 1 trial, this research focuses on understanding how casein protein works in people, offering participants a chance to contribute to groundbreaking nutritional science.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that casein protein is likely safe for most people when taken orally. Most adults experience no side effects from consuming it. Casein, a dairy protein, digests slowly and may boost metabolism over a longer period compared to proteins like whey. Although studies on its metabolic effects continue, casein is generally considered safe. No strong evidence of harmful effects exists, making it a reliable choice for those managing metabolism or appetite. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using casein protein for metabolism because it may offer a unique way to enhance metabolic rate, especially during sleep. Unlike traditional metabolic boosters, which often rely on stimulants or diet modifications, casein protein is a slow-digesting milk protein that can provide a steady release of amino acids overnight. This slow release could help maintain muscle mass and potentially boost metabolic activity without the jitters or side effects associated with other options. By exploring how casein protein affects metabolism, researchers hope to discover a novel approach to supporting metabolic health that could be easily integrated into daily routines.

What evidence suggests that this trial's treatments could be effective for metabolism?

Research has shown that taking casein protein before bed doesn't significantly affect metabolism or appetite. Some studies suggest that casein offers performance benefits similar to whey protein. However, casein may help burn more fat and increase energy use after exercise, potentially boosting metabolism. Its slow digestion might keep the body's metabolism elevated longer than other proteins and could also prolong feelings of fullness. This trial will explore the effects of casein protein on metabolism when taken at night and in the morning, as participants will receive different combinations of casein and placebo shakes. While casein has some benefits, its specific effects on metabolism in these contexts remain unclear. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am male.

Exclusion Criteria

I have a known health condition like heart disease, IBS, high blood pressure, diabetes, or Crohn's disease.

Lactose intolerant

Having known sleep issues

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants consume casein protein or placebo shakes prior to sleep and in the morning, with metabolic assessments conducted

1 day

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Casein Protein

Trial Overview 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.

How Is the Trial Designed?

Group I: PRO pm, PRO am Experimental Treatment 1 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 am Experimental Treatment 1 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 III: PLAC pm, PRO am Experimental Treatment 1 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 IV: PLAC pm, PLAC pm Placebo Group 1 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.

Who Is Running the Clinical Trial?

Ohio University

Lead Sponsor

Trials

73

Recruited

17,800+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8229753/

Pre-Sleep Casein Supplementation, Metabolism, and ... A summary of the main findings shows limited to no effects on metabolism or appetite when ingesting 24–48 g of casein 30 min before sleep.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3761774/

The Effects of Pre- and Post-Exercise Whey vs. Casein ... There does not appear to be a difference in the performance- enhancing effects between whey and casein proteins. Key points. Females can ...

3. nsuworks.nova.edu nsuworks.nova.edu/ijahsp/vol20/iss2/8/

"Whey Versus Casein Supplementation in Physically Active ... The study found no significant differences in the effects of whey versus casein protein supplementation in physically active, healthy individuals.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0022316622101938

Casein and Soy Protein Meals Differentially Affect Whole- ... The study objective was to assess the quality of casein and soy protein by comparing their metabolic effects in healthy human subjects.

5. jissn.biomedcentral.com jissn.biomedcentral.com/articles/10.1186/s12970-018-0263-6

Metabolic impact of protein feeding prior to moderate-intensity ... Pre-exercise casein protein supplementation significantly increased rates of post-exercise fat oxidation and energy expenditure while whey ...

6. webmd.com webmd.com/vitamins/ai/ingredientmono-1575/casein-protein

Casein Protein - Uses, Side Effects, and more When taken by mouth: Casein protein is LIKELY SAFE for most people when taken by mouth. Most adults do not experience side effects when casein protein is taken ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10815430/

Investigating the Health Implications of Whey Protein ... The review reveals significant findings, such as WP's potential link to liver and kidney damage, alterations in gut microbiota, increased acne incidence, ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06250270?cond=Metabolism&viewType=Table&rank=5

Effects of Casein Protein on Metabolism When Taken Prior ... 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.

9. ajcn.nutrition.org ajcn.nutrition.org/article/S0002-9165(23)29152-2/fulltext

Compared with casein or total milk protein, digestion of milk ... Our data showed significant differences in both postprandial aminoacidemia and the time course of dietary nitrogen appearance in the body nitrogen pools ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S2666379123005402

The anabolic response to protein ingestion during recovery ... We show that the ingestion of 100 g protein results in a greater and more prolonged (>12 h) anabolic response when compared to the ingestion of 25 g protein.