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

Ohio University

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Metabolism

Treatments: Dietary Supplement: protein or placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06250270

22-F-7

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: Male

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• male
• aged 18-30

Exclusion criteria

• 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)
• those that have disordered eating
• unwillingness to take blood sugar four times a day
• being a female

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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15 participants in 4 patient groups, including a placebo group

PRO pm, PRO am

Experimental group

Description:

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.

Treatment:

Dietary Supplement: protein or placebo

PRO pm, PLAC am

Experimental group

Description:

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.

Treatment:

Dietary Supplement: protein or placebo

PLAC pm, PRO am

Experimental group

Description:

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.

Treatment:

Dietary Supplement: protein or placebo

PLAC pm, PLAC pm

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: protein or placebo