Impact of Whey and Soy Protein Ingestion in Conjunction With Energy Restriction in Overweight/Obese Individuals
This study is currently recruiting participants.
Verified October 2012 by McMaster University
Sponsor:
McMaster University
Collaborator:
National Dairy Council
Information provided by (Responsible Party):
McMaster University
ClinicalTrials.gov Identifier:
NCT01530646
First received: August 4, 2011
Last updated: October 31, 2012
Last verified: October 2012
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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 |
Dietary Supplement: Control Behavioral: 750 kcal dietary restriction (soy protein group) Dietary Supplement: Soy protein group Dietary Supplement: Whey protein group Behavioral: 750 kcal dietary restriction (whey protein group) Behavioral: 750 kcal dietary restriction (control group) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized 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 ]
| Estimated Enrollment: | 42 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Control Group 0 g protein
Control group in which subjects will be in a 750 kcal/day energy deficit while they receive a daily supplement (2 x 25 g) of maltodextrin (no protein) for 14 days.
|
Dietary Supplement: Control
2 x 25 g of maltodextrin will be provided to subjects within the control group for 14 days.
Behavioral: 750 kcal dietary restriction (control group)
Diets will be provided to each subject for the entire 14 day period. For subjects within the control group, diets will consist of approximately 55% carbohydrates, 30% fat, and 15% protein.
|
|
Experimental: 50 g whey protein
Experimental group in which subjects will be in a 750 kcal/day energy deficit while they receive a daily supplement (2 x 25 g) of whey protein for 14 days.
|
Dietary Supplement: Whey protein group
2 x 25 g of whey protein per day will be provided to the subjects in the whey protein group for 14 days.
Behavioral: 750 kcal dietary restriction (whey protein group)
Diets will be provided for the entire 14 day period. For subjects within the whey protein group, diets will consist of approximately 45% carbohydrates, 30% fat and 25% protein.
|
|
Experimental: Experimental 50 g soy
Experimental group in which subjects will be in a 750 kcal/day energy deficit while they receive a daily supplement (2 x 25 g) of soy protein for 14 days.
|
Behavioral: 750 kcal dietary restriction (soy protein group)
Diets will be provided for the entire 14 day period. For subjects within the soy protein group, diets will consist of approximately 45% carbohydrates, 30% fat and 25% protein.
Dietary Supplement: Soy protein group
2 x 25 g of soy protein per day will be provided to subjects within the soy protein group for 14 days.
|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01530646
Contacts
| Contact: Stuart Phillips, Ph.D. | 905-525-9140 ext 24465 | phillis@mcmaster.ca |
Locations
| Canada, Ontario | |
| McMaster University | Recruiting |
| Hamilton, Ontario, Canada | |
| Contact: Stuart Phillips, Ph.D. 905-525-9140 ext 24465 phillis@mcmaster.ca | |
| Principal Investigator: Stuart Phillips, Ph.D. | |
Sponsors and Collaborators
McMaster University
National Dairy Council
Investigators
| Principal Investigator: | Stuart Phillips, Ph.D. | Department of Kinesiology, McMaster University |
More Information
No publications provided
| Responsible Party: | McMaster University |
| ClinicalTrials.gov Identifier: | NCT01530646 History of Changes |
| Other Study ID Numbers: | 11-999 |
| Study First Received: | August 4, 2011 |
| Last Updated: | October 31, 2012 |
| 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 May 23, 2013