NCT03573687

Brief Summary

The extent to which resistance exercise training and protein timing effects localized (belly fat) and systemic (whole body) fat metabolism in resistance-trained women is unknown. Therefore, this study will assess subcutaneous abdominal adipose tissue lipolytic rate and whole body substrate utilization over the course of two trials: 1) consuming casein protein during the day, and 2) consuming casein protein at night, before bed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

March 20, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 29, 2018

Completed
Last Updated

July 6, 2018

Status Verified

July 1, 2018

Enrollment Period

12 months

First QC Date

January 23, 2017

Last Update Submit

July 5, 2018

Conditions

Keywords

proteinlipolysisfat oxidationresistance trainingnutrient timing

Outcome Measures

Primary Outcomes (1)

  • Lipolysis

    Lipolysis is the way that fat cells mobilize the stored fat to enter into blood circulation. Lipolysis can be measured using a technique called microdialysis. In short, a semi-permeable probe is inserted into the subcutaneous abdominal adipose tissue (SCAAT, or belly fat). Saline combined with a minute amount of ethanol is perfused into the SCAAT, and interstitial fluid is collected out. The concentration of ethanol in the interstitial fluid sample is an indicator of blood flow within the tissue. Glycerol and free fatty acid concentration is measured to indicated rate of fat metabolism (specifically glycerol). The area under the curve for glycerol concentration over time (AUCgly) will be calculated for each of time point. Microdialysis dialysate samples will be measured during the NP and DP trials at fifteen separate time points throughout each visit.

    18 hours

Secondary Outcomes (2)

  • Hormone Concentrations

    18 hours

  • Fat oxidation

    18 hours

Study Arms (3)

RT on Fat Metabolism

EXPERIMENTAL

Determine the extent to which a full-body acute RT protocol will affect intra-RT and post-RT SCAAT lipolytic rate, and post-RT whole-body substrate utilization in RT women compared to baseline measures (independent of Aims 2 and 3).

Other: Resistance Exercise Training

PRO Timing on Fat Metabolism

EXPERIMENTAL

Assess the differences in overnight and next morning SCAAT lipolytic rate and next-morning whole-body substrate utilization compared to baseline between acute NP and DP consumption trials after a RT bout in RT women.

Dietary Supplement: Micellar Casein ProteinOther: Resistance Exercise Training

PRO Timing on Markers of Fat Metabolism

EXPERIMENTAL

Assess the differences in overnight and next morning metabolic biomarkers of fat metabolism compared to baseline between acute nighttime PRO (NP) consumption versus daytime PRO (DP) consumption trials after a RT bout in RT women.

Dietary Supplement: Micellar Casein ProteinOther: Resistance Exercise Training

Interventions

Micellar Casein ProteinDIETARY_SUPPLEMENT

The micellar casein protein supplement (PRO, total protein content: 30 g, 120 kcals; 30 g micellar protein) and non-caloric sensory-matched placebo (PLA, 0kcals) will be specifically formulated by Dymatize® Nutrition FrieslandCampina® and consumed in a randomized order. Participants will consume the daytime supplement 30 minutes after RT and the nighttime supplement about 30 minutes before bedtime. The supplements will be premixed, taste-matched (chocolate), and provided in opaque shaker bottles.

PRO Timing on Fat MetabolismPRO Timing on Markers of Fat Metabolism

Resistance exercise training (RT) will target the full body and exercises will be performed using a barbell. Exercises will be performed in the following order: back squat, bench press, Romanian deadlift, bent-over row, shoulder press, and reverse lunges)

PRO Timing on Fat MetabolismPRO Timing on Markers of Fat MetabolismRT on Fat Metabolism

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Resistance-trained (able to squat 1.0 times their body weight, and bench press 0.75 times body weight, adapted from ACSM Guidelines and piloted in our laboratory)
  • Normal weight (BMI = 18.5-25 kg/m2; body fat \<33%)
  • Normally menstruating (on or off oral contraceptives)
  • Females.

You may not qualify if:

  • Uncontrolled thyroid dysfunction (not on medication)
  • Musculoskeletal disorders
  • Currently smoke
  • Have milk allergies
  • Currently take medications or supplements known to affect substrate metabolism.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Sports Sciences and Medicine, Florida State University

Tallahassee, Florida, 32306, United States

Location

Related Publications (1)

  • Allman BR, Morrissey MC, Kim JS, Panton LB, Contreras RJ, Hickner RC, Ormsbee MJ. Lipolysis and Fat Oxidation Are Not Altered with Presleep Compared with Daytime Casein Protein Intake in Resistance-Trained Women. J Nutr. 2020 Jan 1;150(1):47-54. doi: 10.1093/jn/nxz186.

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
The supplements will be made by a third party person and premixed, taste-matched, and provided in opaque shaker bottles.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Randomized, crossover, double-blind, acute study with two conditions: nighttime PRO consumption (NP) and daytime PRO consumption (DP).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 23, 2017

First Posted

June 29, 2018

Study Start

March 20, 2017

Primary Completion

February 28, 2018

Study Completion

February 28, 2018

Last Updated

July 6, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations