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Daily Protein Intake Distribution and MPS (ARCIII)

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ClinicalTrials.gov Identifier: NCT02315014
Recruitment Status : Completed
First Posted : December 11, 2014
Last Update Posted : December 11, 2014
Sponsor:
Information provided by (Responsible Party):
Nestlé

Brief Summary:
To determine whether a balanced total daily dietary protein distribution supplemented with whey protein during a weight-loss intervention will result in increased muscle protein synthesis

Condition or disease Intervention/treatment Phase
Overweight Other: whey protein Other: placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Effect of Balanced Daily Protein Distribution Supplemented With Whey Protein on Muscle Protein Synthesis in Overweight Older Men During Calorie Restriction and Exercise (ARC III)
Study Start Date : March 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2014

Arm Intervention/treatment
Experimental: whey protein
whey protein micelles
Other: whey protein
whey protein.

Placebo Comparator: placebo
calorie-free placebo
Other: placebo
placebo.




Primary Outcome Measures :
  1. muscle protein synthesis [ Time Frame: up to 4 weeks ]
    protein synthesis is evaluated in muscle biopsy tissue


Secondary Outcome Measures :
  1. body composition is evaluated using DEXA [ Time Frame: up to 4 weeks ]


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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Overweight/obese (BMI 27-40 kg/m2)
  • Non-smokers
  • Non-diabetic
  • No history of hyperlipidemia
  • Not taking medications thought to interfere with study
  • Considered generally healthy

Exclusion Criteria:

  • Efforts to lose weight in previous 16 weeks
  • Hyperlipidemia
  • Blood pressure ≥ 140/90 mmHg
  • Smoking
  • Heart and other organ disease
  • Type 2 diabetes
  • Gastrointestinal disease
  • Orthopedic injury interfering with exercise
  • Use of certain medications (HRT, antihypertensives, diuretics, antiarythmia medications, antiresorptive agents, anabolic agents, hypoglycemic agents, and statins known to affect muscle i.e. Simvastatin and Zocor)

Information from the National Library of Medicine

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): NCT02315014


Sponsors and Collaborators
Nestlé
Investigators
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Principal Investigator: Stuart Phillips, Ph.D. McMaster University

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Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT02315014     History of Changes
Other Study ID Numbers: 12.12.NRC
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: December 11, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms