Protect, The impact of a high protein diet on the preservation of muscle mass during caloric restriction in overweight middle-aged to elderly people

Protect, The impact of a high protein diet on the preservation of muscle mass during caloric restriction in overweight middle-aged to elderly people - Protect

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37859

Enrollment

Registered

2012-03-08

Start date

2012-08-13

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

obesitas loss of muscle mass during weight reduction

Interventions

All subjects consume a caloric restricted (25%) diet for 12 weeks. Subjects are at random divided in 2 groups: 1. High protein diet with caloric restriction 30% protein, 40% carbohydrates, 30% fat

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Overweight or obese (BMI 27-35 kg/m2) - Waist circumference male: >=102 cm, female: >=88cm - Age in between 55-70 years - Willingness and ability to comply with the protocol

Exclusion criteria

Exclusion criteria: - Renal insufficiency (MDRD eGFR > 60ml/min/1.73 m2) - Type 1 or type II diabetes (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 years - 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 - For women: last period >= 1 year ago

Design outcomes

Primary

Measure	Time frame
Difference in Skeletal muscle mass after 12 weeks	—

Secondary

Measure	Time frame
Secondary outcome measures: • BMI • Body weight • Total fat mass (DXA) • Bone mineral density (DXA) • Leg strength (1RM leg press/extension) • Handgrip strength • Physical performance (SPPB, 400 m walk test) • Activities of daily living • Muscle fiber/type size, satellite cells (biopsy) • Fasting glucose level • 2-h plasma glucose level (assessed by OGTT) • HbA1c • Insulin • Lipid profile • Habitual physical activity (Accelerometer) • Microbial composition and metabolite profiles. - Gene expression in adiopose tissue	—

Measure

Time frame

Secondary outcome measures: • BMI • Body weight • Total fat mass (DXA) • Bone mineral density (DXA) • Leg strength (1RM leg press/extension) • Handgrip strength • Physical performance (SPPB, 400 m walk test) • Activities of daily living • Muscle fiber/type size, satellite cells (biopsy) • Fasting glucose level • 2-h plasma glucose level (assessed by OGTT) • HbA1c • Insulin • Lipid profile • Habitual physical activity (Accelerometer) • Microbial composition and metabolite profiles. - Gene expression in adiopose tissue

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)