Impact of Whey and Soy Protein Ingestion in Conjunction With Energy Restriction in Overweight/Obese Individuals
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ClinicalTrials.gov Identifier: NCT01530646 |
Recruitment Status :
Completed
First Posted : February 10, 2012
Last Update Posted : June 9, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obesity | Behavioral: Weight loss Dietary Supplement: Soy Dietary Supplement: Whey | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 42 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, 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 |
Study Start Date : | February 2012 |
Actual Primary Completion Date : | February 2013 |
Actual Study Completion Date : | May 2013 |
Arm | Intervention/treatment |
---|---|
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.
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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.
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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.
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Behavioral: Weight loss
-750kcal/d Dietary Supplement: Soy 2 x 25g/d SPC |
- Muscle protein synthesis rate and lipolytic rate as measured using stable isotope and glycerol infusions. [ Time Frame: After 14 day dietary intervention ]
- 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 ]

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Ages Eligible for Study: | 35 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | 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:
- 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01530646
Canada, Ontario | |
McMaster University | |
Hamilton, Ontario, Canada |
Principal Investigator: | Stuart Phillips, Ph.D. | Department of Kinesiology, McMaster University |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Stuart M. Phillips, Professor, McMaster University |
ClinicalTrials.gov Identifier: | NCT01530646 |
Other Study ID Numbers: |
11-999 |
First Posted: | February 10, 2012 Key Record Dates |
Last Update Posted: | June 9, 2015 |
Last Verified: | June 2015 |
obesity overweight muscle protein muscle protein synthesis |
muscle protein breakdown whey soy caloric restriction |
Overweight Body Weight |