Daily Protein Intake Distribution and MPS (ARCIII)

Overweight Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02315014
• Other study ID #: 12.12.NRC
• Status: Completed
• Phase: N/A
• First received: November 13, 2014
• Last updated: December 10, 2014
• Start date: March 2013
• Est. completion date: June 2014

Study information

• Verified date: November 2014
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 60 Years to 75 Years

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Overweight

Intervention

Other:
• whey protein
whey protein.
• placebo
placebo.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	muscle protein synthesis	protein synthesis is evaluated in muscle biopsy tissue	up to 4 weeks	No
Secondary	body composition is evaluated using DEXA		up to 4 weeks	No