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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2012-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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High protein diet

High protein diet during caloric restriction

Group Type EXPERIMENTAL

High protein diet

Intervention Type OTHER

controlled feeding trail. Both arms are caloric restricted

Standard protein diet

Standard protein diet during caloric restriction

Group Type PLACEBO_COMPARATOR

standard protein diet

Intervention Type OTHER

Interventions

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High protein diet

controlled feeding trail. Both arms are caloric restricted

Intervention Type OTHER

standard protein diet

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

55 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes