Protect - The Impact of a High Protein Diet on Preservation of Muscle Mass

Obesity Clinical Trial

Official title:

Protect The Impact of a High Protein Diet on the Preservation of Muscle Mass During Caloric Restriction in Middle Age and Elderly People

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01915030
• Other study ID #: WM002-wp3
• Status: Completed
• Phase: N/A
• First received: July 31, 2012
• Last updated: July 30, 2013
• Start date: June 2012
• Est. completion date: December 2012

Study information

• Verified date: July 2013
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial Summary

The present study is designed to investigate whether a high protein diet will preserve muscle mass during caloric restriction in older adults.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years to 70 Years

Eligibility

Inclusion Criteria:

• Overweight and obese subjects (BMI 27-40 kg/m2)

• Waist circumference male:= 102 cm, female: = 88 cm

• Willingness and ability to comply with the protocol

Exclusion Criteria:

• Renal insufficiency

• Co-morbidities

• Type 1 & 2 diabetics (Fasting glucose level = 7 mmol/L)

• Cancer

• COPD

• Participation in weight loss program 3 months before the intervention

• Participation of any heavy resistance-type exercise training (>1 wk) the last 2 y.

• Intentional or unintentional weight loss (> 3 kg in the last 3 months)

• Severe loss appetite

• Diagnosed allergy to milk products

• Gastric bypass

• Supplements or medication use for weight loss

• Participation in any other intervention trial

• Women can only participate if they are postmenopausal (last period = a year ago)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• High protein diet
controlled feeding trail. Both arms are caloric restricted
• standard protein diet

Locations

Country	Name	City	State
Netherlands	Wageningen University	Wageningen	Gelderland

Sponsors (3)

Lead Sponsor	Collaborator
Wageningen University	Maastricht University, Top Institute Food and Nutrition

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Body composition	DEXA scan	baseline and 12 weeks	No
Secondary	Physical performance	Short Physical Performance Battery (SPPB), maximum score is 12.; Leg strength by 1 Repetition Maximum, both leg extension and leg press; Handgrip strength; Time to walk 400m	baseline and 12 weeks	No
Secondary	Blood related parameters	Glucose, insulin, HbA1c, lipid profile	baseline and 12 weeks	No
Secondary	Muscle related parameters	muscle biopsies (muscle fiber type)	baseline and 12 weeks	No
Secondary	Physical activity	Questionnaire LAPAQ - Activities of Daily Living	baseline and 12 weeks	No