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

February 7, 2024 updated by: Angela Hillman, Ohio University
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ohio
      • Athens, Ohio, United States, 45701
        • Recruiting
        • Ohio University Exercise Physiology Lab
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
casein protein (30g) or placebo (maltodextrin, 30g)
Experimental: 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.
casein protein (30g) or placebo (maltodextrin, 30g)
Experimental: 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.
casein protein (30g) or placebo (maltodextrin, 30g)
Placebo Comparator: 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.
casein protein (30g) or placebo (maltodextrin, 30g)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
dietary intake
Time Frame: during the intervention
food logs used to track food intake during all trial visits
during the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

January 31, 2024

First Submitted That Met QC Criteria

February 7, 2024

First Posted (Actual)

February 9, 2024

Study Record Updates

Last Update Posted (Actual)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 22-F-7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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