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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01915030

Enrollment

Registered

2013-08-02

Start date

2012-06-30

Completion date

2012-12-31

Last updated

2013-08-02

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

Conditions

Obesity

Keywords

Muscle, Physical performance, Protein, Diet, Caloric restriction

Brief summary

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

Interventions

OTHERHigh protein diet

controlled feeding trail. Both arms are caloric restricted

OTHERstandard protein diet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

55 Years to 70 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
Change in Body composition	baseline and 12 weeks	DEXA scan

Secondary

Measure	Time frame	Description
Physical performance	baseline and 12 weeks	1. Short Physical Performance Battery (SPPB), maximum score is 12. 2. Leg strength by 1 Repetition Maximum, both leg extension and leg press 3. Handgrip strength 4. Time to walk 400m
Blood related parameters	baseline and 12 weeks	Glucose, insulin, HbA1c, lipid profile
Muscle related parameters	baseline and 12 weeks	muscle biopsies (muscle fiber type)
Physical activity	baseline and 12 weeks	Questionnaire LAPAQ - Activities of Daily Living

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026