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OpenTrials
Completed

NCT Number: NCT01915030

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

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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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

55 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wageningen University

Wageningen, Gelderland, 6703HD, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

High protein diet

Other

controlled feeding trail. Both arms are caloric restricted

standard protein diet

Other

Primary outcomes

  1. Change in Body composition

    Time frame: baseline and 12 weeks

    DEXA scan

Secondary outcomes

  1. Physical performance

    Time frame: baseline and 12 weeks

    • 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

  2. Blood related parameters

    Time frame: baseline and 12 weeks

    Glucose, insulin, HbA1c, lipid profile

  3. Muscle related parameters

    Time frame: baseline and 12 weeks

    muscle biopsies (muscle fiber type)

  4. Physical activity

    Time frame: baseline and 12 weeks

    Questionnaire LAPAQ - Activities of Daily Living

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Collaborators

  • Maastricht University
  • Top Institute Food and Nutrition

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Aug 2, 2013
Registry last updated
Aug 2, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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