Impact of Whey and Soy Protein Ingestion in Conjunction With Energy Restriction in Overweight/Obese Individuals
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Weight loss
Soy
Whey
Sponsored by

About this trial
This is an interventional treatment trial for Obesity focused on measuring obesity, overweight, muscle, protein, muscle protein synthesis, muscle protein breakdown, whey, soy, caloric restriction
Eligibility Criteria
Inclusion Criteria:
- Aged 35 to 55 years old
- Moderately Obese/Overweight (body mass index > 25 and < 42 kg/m2)
- Healthy
- Non-smoker
Exclusion Criteria:
- 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)
Sites / Locations
- McMaster University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Control
Whey
Soy
Arm Description
Carbohydrate & 750 kcal dietary restriction while they receive a daily supplement (2 x 25 g) of maltodextrin (no protein) for 14 days. Weight loss.
Whey protein & 750 kcal dietary restriction while they receive a daily supplement (2 x 25 g) of WPI for 14 days. Weight loss.
Soy protein & 750 kcal dietary restriction while they receive a daily supplement (2 x 25 g) of SPC for 14 days. Weight loss.
Outcomes
Primary Outcome Measures
Muscle protein synthesis rate and lipolytic rate as measured using stable isotope and glycerol infusions.
Secondary Outcome Measures
Transcriptomic changes (via gene profiling) associated with the effects of whey on lipogenic and lipid oxidative genes, and protein synthetic pathways in muscle.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01530646
Brief Title
Impact of Whey and Soy Protein Ingestion in Conjunction With Energy Restriction in Overweight/Obese Individuals
Official Title
Molecular Events Underpinning Changes in Tissue Metabolism With Whey and Soy Ingestion in Energy Restriction in Overweight/Obese Adults
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, overweight, muscle, protein, muscle protein synthesis, muscle protein breakdown, whey, soy, caloric restriction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Carbohydrate & 750 kcal dietary restriction while they receive a daily supplement (2 x 25 g) of maltodextrin (no protein) for 14 days. Weight loss.
Arm Title
Whey
Arm Type
Experimental
Arm Description
Whey protein & 750 kcal dietary restriction while they receive a daily supplement (2 x 25 g) of WPI for 14 days. Weight loss.
Arm Title
Soy
Arm Type
Experimental
Arm Description
Soy protein & 750 kcal dietary restriction while they receive a daily supplement (2 x 25 g) of SPC for 14 days. Weight loss.
Intervention Type
Behavioral
Intervention Name(s)
Weight loss
Intervention Description
-750kcal/d
Intervention Type
Dietary Supplement
Intervention Name(s)
Soy
Intervention Description
2 x 25g/d SPC
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey
Intervention Description
2 x 25g/d WPI
Primary Outcome Measure Information:
Title
Muscle protein synthesis rate and lipolytic rate as measured using stable isotope and glycerol infusions.
Time Frame
After 14 day dietary intervention
Secondary Outcome Measure Information:
Title
Transcriptomic changes (via gene profiling) associated with the effects of whey on lipogenic and lipid oxidative genes, and protein synthetic pathways in muscle.
Time Frame
After 14 days of dietary intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Aged 35 to 55 years old
Moderately Obese/Overweight (body mass index > 25 and < 42 kg/m2)
Healthy
Non-smoker
Exclusion Criteria:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart Phillips, Ph.D.
Organizational Affiliation
Department of Kinesiology, McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
25644344
Citation
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. Erratum In: J Nutr. 2015 Jun;145(6):1373.
Results Reference
result
PubMed Identifier
29233792
Citation
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.
Results Reference
derived
PubMed Identifier
24284442
Citation
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.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/25644344
Description
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Impact of Whey and Soy Protein Ingestion in Conjunction With Energy Restriction in Overweight/Obese Individuals
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