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

This study has been completed.
Sponsor:
Collaborator:
Dairy Research Institute - Whey Protein Research Consortium
Information provided by (Responsible Party):
Stuart M. Phillips, McMaster University
ClinicalTrials.gov Identifier:
NCT01530646
First received: August 4, 2011
Last updated: July 20, 2014
Last verified: July 2014
  Purpose

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 Intervention
Obesity
Behavioral: Weight loss
Dietary Supplement: Soy
Dietary Supplement: Whey

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Muscle protein synthesis rate and lipolytic rate as measured using stable isotope and glycerol infusions. [ Time Frame: After 14 day dietary intervention ] [ Designated as safety issue: No ]

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. [ Time Frame: After 14 days of dietary intervention ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: February 2012
Study Completion Date: May 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   35 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 35 to 55 years old
  • Moderately Obese/Overweight (body mass index > 30 and < 40 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01530646

Locations
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada
Sponsors and Collaborators
McMaster University
Dairy Research Institute - Whey Protein Research Consortium
Investigators
Principal Investigator: Stuart Phillips, Ph.D. Department of Kinesiology, McMaster University
  More Information

No publications provided

Responsible Party: Stuart M. Phillips, Professor, McMaster University
ClinicalTrials.gov Identifier: NCT01530646     History of Changes
Other Study ID Numbers: 11-999
Study First Received: August 4, 2011
Last Updated: July 20, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
obesity
overweight
muscle
protein
muscle protein synthesis
muscle protein breakdown
whey
soy
caloric restriction

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014