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Impact of Whey and Soy Protein Ingestion in Conjunction With Energy Restriction in Overweight/Obese Individuals

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ClinicalTrials.gov Identifier: NCT01530646
Recruitment Status : Completed
First Posted : February 10, 2012
Last Update Posted : June 9, 2015
Sponsor:
Information provided by (Responsible Party):
Stuart M. Phillips, McMaster University

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).

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Weight loss Dietary Supplement: Soy Dietary Supplement: Whey Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Molecular Events Underpinning Changes in Tissue Metabolism With Whey and Soy Ingestion in Energy Restriction in Overweight/Obese Adults
Study Start Date : February 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : May 2013

Arm Intervention/treatment
Placebo Comparator: Control
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
-750kcal/d
Experimental: Whey
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 loss
-750kcal/d
Dietary Supplement: Whey
2 x 25g/d WPI
Experimental: Soy
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 loss
-750kcal/d
Dietary Supplement: Soy
2 x 25g/d SPC



Primary Outcome Measures :
  1. Muscle protein synthesis rate and lipolytic rate as measured using stable isotope and glycerol infusions. [ Time Frame: After 14 day dietary intervention ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   35 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01530646


Locations
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada
Sponsors and Collaborators
McMaster University
Investigators
Principal Investigator: Stuart Phillips, Ph.D. Department of Kinesiology, McMaster University

Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stuart M. Phillips, Professor, McMaster University
ClinicalTrials.gov Identifier: NCT01530646     History of Changes
Other Study ID Numbers: 11-999
First Posted: February 10, 2012    Key Record Dates
Last Update Posted: June 9, 2015
Last Verified: June 2015

Keywords provided by Stuart M. Phillips, McMaster University:
obesity
overweight
muscle
protein
muscle protein synthesis
muscle protein breakdown
whey
soy
caloric restriction

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms