Impact of Whey and Soy Protein Ingestion in Conjunction With Energy Restriction in Overweight/Obese Individuals
Molecular Events Underpinning Changes in Tissue Metabolism With Whey and Soy Ingestion in Energy Restriction in Overweight/Obese Adults
1 other identifier
interventional
42
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Feb 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2011
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedFirst Posted
Study publicly available on registry
February 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedJune 9, 2015
June 1, 2015
1 year
August 4, 2011
June 6, 2015
Conditions
Keywords
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 COMPARATORCarbohydrate \& 750 kcal dietary restriction while they receive a daily supplement (2 x 25 g) of maltodextrin (no protein) for 14 days. Weight loss.
Whey
EXPERIMENTALWhey protein \& 750 kcal dietary restriction while they receive a daily supplement (2 x 25 g) of WPI for 14 days. Weight loss.
Soy
EXPERIMENTALSoy protein \& 750 kcal dietary restriction while they receive a daily supplement (2 x 25 g) of SPC for 14 days. Weight loss.
Interventions
Eligibility Criteria
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
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.
PMID: 25644344RESULTPaschalis 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.
PMID: 29233792DERIVEDChurchward-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.
PMID: 24284442DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stuart Phillips, Ph.D.
Department of Kinesiology, McMaster University
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