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CompletedNCT01530646Updated Jun 9, 2015

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

An interventional study of Weight loss and Soy in Obesity, sponsored by McMaster University. Completed at 1 site in Canada. Open to participants aged 35 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-06-09.

Sponsored by McMaster University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
35 Years to 65 Years
Sex
All
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Study 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).

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Conditions studied

  • Obesity

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Keywords

  • obesity
  • overweight
  • muscle
  • protein
  • muscle protein synthesis
  • muscle protein breakdown
  • whey
  • soy
  • caloric restriction
03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's enrollment of 42 is below the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

McMaster University is the lead sponsor of 720 studies on the registry; 124 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Aged 35 to 55 years old
  • Moderately Obese/Overweight (body mass index > 25 and \< 42 kg/m2)
  • Healthy
  • Non-smoker

Exclusion criteria

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)
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
42 participants (actual)

Study arms

  • 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

  • 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 · Dietary Supplement: Whey

  • 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 · Dietary Supplement: Soy

Interventions

  • BehavioralWeight loss

    -750kcal/d

  • Dietary supplementSoy

    2 x 25g/d SPC

  • Dietary supplementWhey

    2 x 25g/d WPI

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What researchers measure

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

07

Study locations

1 site
  • McMaster University
    Hamilton, Ontario, Canada
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References and documents

Publications

  • 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 Nutr. 2015 Feb;145(2):246-52. doi: 10.3945/jn.114.200832. Epub 2014 Dec 17. Erratum In: J Nutr. 2015 Jun;145(6):1373. doi: 10.3945/jn.115.214361. PubMed 25644344 ↗
  • Paschalis V, Theodorou AA, Margaritelis NV, Kyparos A, Nikolaidis MG. N-acetylcysteine supplementation increases exercise performance and reduces oxidative stress only in individuals with low levels of glutathione. Free Radic Biol Med. 2018 Feb 1;115:288-297. doi: 10.1016/j.freeradbiomed.2017.12.007. Epub 2017 Dec 9. PubMed 29233792 ↗
  • Churchward-Venne TA, Breen L, Di Donato DM, Hector AJ, Mitchell CJ, Moore DR, Stellingwerff T, Breuille D, Offord EA, Baker SK, Phillips SM. Leucine supplementation of a low-protein mixed macronutrient beverage enhances myofibrillar protein synthesis in young men: a double-blind, randomized trial. Am J Clin Nutr. 2014 Feb;99(2):276-86. doi: 10.3945/ajcn.113.068775. Epub 2013 Nov 27. PubMed 24284442 ↗

Related links

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01530646
Lead sponsor
McMaster University
Responsible party
Stuart M. Phillips (Professor, McMaster University) — Principal investigator
First posted
Feb 10, 2012
Start date
Feb 2012
Primary completion
Feb 2013
Completion
May 2013
Last update
Jun 9, 2015

Study contacts

Stuart Phillips, Ph.D.
principal investigator · Department of Kinesiology, McMaster University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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