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

NCT ID: NCT06250270

Last Updated: 2025-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Metabolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Blinded pre-made packets of protein or placebo with sample coding in a sealed envelope until the end of the study

Study Groups

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PRO pm, PRO am

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 Type EXPERIMENTAL

protein or placebo

Intervention Type DIETARY_SUPPLEMENT

casein protein (30g) or placebo (maltodextrin, 30g)

PRO pm, PLAC am

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 Type EXPERIMENTAL

protein or placebo

Intervention Type DIETARY_SUPPLEMENT

casein protein (30g) or placebo (maltodextrin, 30g)

PLAC pm, PRO am

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 Type EXPERIMENTAL

protein or placebo

Intervention Type DIETARY_SUPPLEMENT

casein protein (30g) or placebo (maltodextrin, 30g)

PLAC pm, PLAC pm

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 Type PLACEBO_COMPARATOR

protein or placebo

Intervention Type DIETARY_SUPPLEMENT

casein protein (30g) or placebo (maltodextrin, 30g)

Interventions

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protein or placebo

casein protein (30g) or placebo (maltodextrin, 30g)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ohio University

OTHER

Sponsor Role lead

Responsible Party

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Angela Hillman

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ohio University Exercise Physiology Lab

Athens, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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22-F-7

Identifier Type: -

Identifier Source: org_study_id

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