Study to Assess the Effects of High Protein Diet in Obesity, the LOWER Study

University Medical Center Groningen (UMCG)

Status: Completed

Conditions: Obesity

Treatments: Dietary Supplement: Normal protein energy-restricted; Dietary Supplement: High protein energy-restricted

Study type: Interventional

Funder types: Other

Identifiers

NCT00862953

BWO08-002

Details and patient eligibility

About

This program is carried out in a dedicated outpatient-clinic in the city of Hengelo for the evaluation and treatment of subjects with obesity. The program puts emphasis on intervention with appropriate diet and physical exercise, and supports the patients in achieving long-term behaviour changes. Interventions which are compared are normal vs high protein/low carb diets.

Full description

Assessment focuses on the effect of the specific diets on weight reduction after 3 months, and weight maintenance after 12 months.

Enrollment: 317 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Obesity with BMI > 27 kg/m2

Exclusion criteria

• Recent loss of body weight (>10%)
• Underlying malignancy, HIV infection, psychiatric disease
• Pregnancy or breast feeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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317 participants in 4 patient groups

Normal protein normal carbohydrate

Active Comparator group

Description:

Normal protein normal carbohydrate calory restricted nutrition

Treatment:

Dietary Supplement: Normal protein energy-restricted

Normal protein low carbohydrates

Experimental group

Description:

Normal protein low carbohydrate energy-restricted diet

Treatment:

Dietary Supplement: Normal protein energy-restricted

High protein normal carbohydrates

Experimental group

Description:

High protein normal carbohydrates

Treatment:

Dietary Supplement: High protein energy-restricted

High protein low carbohydrate

Experimental group

Description:

High protein low carbohydrate nutrition

Treatment:

Dietary Supplement: High protein energy-restricted