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

Obesity Clinical Trial

Official title:

Molecular Events Underpinning Changes in Tissue Metabolism With Whey and Soy Ingestion in Energy Restriction in Overweight/Obese Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01530646
• Other study ID #: 11-999
• Status: Completed
• Phase: N/A
• First received: August 4, 2011
• Last updated: June 6, 2015
• Start date: February 2012
• Est. completion date: May 2013

Study information

• Verified date: June 2015
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• Weight loss
-750kcal/d

Dietary Supplement:
• Soy
2 x 25g/d SPC
• Whey
2 x 25g/d WPI

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle protein synthesis rate and lipolytic rate as measured using stable isotope and glycerol infusions.		After 14 day dietary intervention	No
Secondary	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	No

External Links

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