NCT01530646

Brief Summary

It is known that dieting (restricted energy intake) without resistance training leads to a reduced metabolic rate, and the loss of both fat and muscle mass. When exercise is not included in a period of restricted energy intake, the degree to which muscle mass is lost is highly dependent upon protein consumption. Whey protein is a high quality protein isolated from milk and is known to stimulate new protein synthesis for all proteins in your body. Previous research has established that the consumption of whey protein has been correlated with retaining muscle mass while stimulating fat loss. However, the mechanisms behind these findings is still unknown. The purpose of this study is to establish a mechanistic underpinning to the efficacy of whey protein versus soy protein and a carbohydrate control (maltodextrin), in promoting fat mass loss and lean mass retention during a period of short-term controlled dietary energy deficit (-750 kcalories/day).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Feb 2012

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

August 4, 2011

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 10, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

June 9, 2015

Status Verified

June 1, 2015

Enrollment Period

1 year

First QC Date

August 4, 2011

Last Update Submit

June 6, 2015

Conditions

Keywords

obesityoverweightmuscleproteinmuscle protein synthesismuscle protein breakdownwheysoycaloric restriction

Outcome Measures

Primary Outcomes (1)

  • Muscle protein synthesis rate and lipolytic rate as measured using stable isotope and glycerol infusions.

    After 14 day dietary intervention

Secondary Outcomes (1)

  • Transcriptomic changes (via gene profiling) associated with the effects of whey on lipogenic and lipid oxidative genes, and protein synthetic pathways in muscle.

    After 14 days of dietary intervention

Study Arms (3)

Control

PLACEBO COMPARATOR

Carbohydrate \& 750 kcal dietary restriction while they receive a daily supplement (2 x 25 g) of maltodextrin (no protein) for 14 days. Weight loss.

Behavioral: Weight loss

Whey

EXPERIMENTAL

Whey protein \& 750 kcal dietary restriction while they receive a daily supplement (2 x 25 g) of WPI for 14 days. Weight loss.

Behavioral: Weight lossDietary Supplement: Whey

Soy

EXPERIMENTAL

Soy protein \& 750 kcal dietary restriction while they receive a daily supplement (2 x 25 g) of SPC for 14 days. Weight loss.

Behavioral: Weight lossDietary Supplement: Soy

Interventions

Weight lossBEHAVIORAL

-750kcal/d

ControlSoyWhey
SoyDIETARY_SUPPLEMENT

2 x 25g/d SPC

Soy
WheyDIETARY_SUPPLEMENT

2 x 25g/d WPI

Whey

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 35 to 55 years old
  • Moderately Obese/Overweight (body mass index \> 25 and \< 42 kg/m2)
  • Healthy
  • Non-smoker

You may not qualify if:

  • Suffer from type 2 diabetes, hyperlipidemia, or thyroid dysfunction
  • Taking medications
  • Having an unstable weight in the past 4-6 months, or dieting at some time during the past 6 months
  • Taking weight loss products or aids (including energy drinks)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University

Hamilton, Ontario, Canada

Location

Related Publications (3)

  • Hector AJ, Marcotte GR, Churchward-Venne TA, Murphy CH, Breen L, von Allmen M, Baker SK, Phillips SM. Whey protein supplementation preserves postprandial myofibrillar protein synthesis during short-term energy restriction in overweight and obese adults. J Nutr. 2015 Feb;145(2):246-52. doi: 10.3945/jn.114.200832. Epub 2014 Dec 17.

  • Paschalis V, Theodorou AA, Margaritelis NV, Kyparos A, Nikolaidis MG. N-acetylcysteine supplementation increases exercise performance and reduces oxidative stress only in individuals with low levels of glutathione. Free Radic Biol Med. 2018 Feb 1;115:288-297. doi: 10.1016/j.freeradbiomed.2017.12.007. Epub 2017 Dec 9.

  • Churchward-Venne TA, Breen L, Di Donato DM, Hector AJ, Mitchell CJ, Moore DR, Stellingwerff T, Breuille D, Offord EA, Baker SK, Phillips SM. Leucine supplementation of a low-protein mixed macronutrient beverage enhances myofibrillar protein synthesis in young men: a double-blind, randomized trial. Am J Clin Nutr. 2014 Feb;99(2):276-86. doi: 10.3945/ajcn.113.068775. Epub 2013 Nov 27.

Related Links

MeSH Terms

Conditions

ObesityOverweight

Interventions

Whey

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MilkBeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Study Officials

  • Stuart Phillips, Ph.D.

    Department of Kinesiology, McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 4, 2011

First Posted

February 10, 2012

Study Start

February 1, 2012

Primary Completion

February 1, 2013

Study Completion

May 1, 2013

Last Updated

June 9, 2015

Record last verified: 2015-06

Locations