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OpenTrials
Completed

NCT Number: NCT01530646

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

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).

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Key information

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McMaster University

Hamilton, Ontario, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Weight Loss

Behavioral

-750kcal/d

Soy

Dietary Supplement

2 x 25g/d SPC

Whey

Dietary Supplement

2 x 25g/d WPI

Primary outcomes

  1. Muscle protein synthesis rate and lipolytic rate as measured using stable isotope and glycerol infusions.

    Time frame: After 14 day dietary intervention

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 10, 2012
Registry last updated
Jun 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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