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

NCT06250270 | Active Not Recruiting Early Phase 1

• 1 other identifier: 22-F-7
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolism

Keywords

Metabolism

Outcome Measures

Primary Outcomes (2)

• resting metabolic rate

  indirect calorimetry to measure oxygen consumption (V02) and respiratory quotient (RQ)

  baseline, during the intervention

• blood glucose

  fasting and pre-meal blood glucose

  baseline, during the intervention

Secondary Outcomes (1)

• dietary intake

  during the intervention

Study Arms (4)

PRO pm, PRO am

EXPERIMENTAL

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.

Dietary Supplement: protein or placebo

PRO pm, PLAC am

EXPERIMENTAL

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.

Dietary Supplement: protein or placebo

PLAC pm, PRO am

EXPERIMENTAL

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.

Dietary Supplement: protein or placebo

PLAC pm, PLAC pm

PLACEBO COMPARATOR

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.

Dietary Supplement: protein or placebo

Interventions

protein or placebo DIETARY_SUPPLEMENT

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

PLAC pm, PLAC pm; PLAC pm, PRO am; PRO pm, PLAC am; PRO pm, PRO am

Eligibility Criteria

• Age: 18 Years - 30 Years
• Gender Eligibility Details: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• male
• aged 18-30

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio University: lead

Study Sites (1)

Ohio University Exercise Physiology Lab

Athens, Ohio, 45701, United States

Location

MeSH Terms

Interventions

Proteins

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Blinded pre-made packets of protein or placebo with sample coding in a sealed envelope until the end of the study
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 9, 2024
• Study Start: October 1, 2022
• Primary Completion: May 1, 2024
• Study Completion: December 31, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)