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

Early Phase 1

Active, not recruiting

• Conditions: Metabolism
• Interventions: Dietary Supplement: protein or placebo

• Registration Number: NCT06250270
• Lead Sponsor: Ohio University

Brief 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. 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

Not available

Study Timeline

• Study Start: 2022-10-01
• Study First Submitted: 2024-01-31
• Study First Submitted QC: 2024-02-07
• Study First Posted: 2024-02-09
• Status Verified: 2024-05
• Primary Completion: 2024-05-01
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-31
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PRO pm, PRO am	protein or placebo	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.
PRO pm, PLAC am	protein or placebo	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.
PLAC pm, PRO am	protein or placebo	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.
PLAC pm, PLAC pm	protein or placebo	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.

Primary Outcome Measures

Name	Time	Method
resting metabolic rate	baseline, during the intervention	indirect calorimetry to measure oxygen consumption (V02) and respiratory quotient (RQ)
blood glucose	baseline, during the intervention	fasting and pre-meal blood glucose

Secondary Outcome Measures

Name	Time	Method
dietary intake	during the intervention	food logs used to track food intake during all trial visits

Trial Locations

Locations (1)

Ohio University Exercise Physiology Lab; 🇺🇸 Athens, Ohio, United States