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

NCT ID: NCT00862953

Last Updated: 2024-04-18

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

317 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-10-31

Brief Summary

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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.

Detailed Description

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

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Normal protein normal carbohydrate

Normal protein normal carbohydrate calory restricted nutrition

Group Type ACTIVE_COMPARATOR

Normal protein energy-restricted

Intervention Type DIETARY_SUPPLEMENT

Normal protein diet energy restricted

Normal protein low carbohydrates

Normal protein low carbohydrate energy-restricted diet

Group Type EXPERIMENTAL

Normal protein energy-restricted

Intervention Type DIETARY_SUPPLEMENT

Normal protein diet energy restricted

High protein normal carbohydrates

High protein normal carbohydrates

Group Type EXPERIMENTAL

High protein energy-restricted

Intervention Type DIETARY_SUPPLEMENT

High protein diet, with either low or normal carbohydrate content

High protein low carbohydrate

High protein low carbohydrate nutrition

Group Type EXPERIMENTAL

High protein energy-restricted

Intervention Type DIETARY_SUPPLEMENT

High protein diet, with either low or normal carbohydrate content

Interventions

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Normal protein energy-restricted

Normal protein diet energy restricted

Intervention Type DIETARY_SUPPLEMENT

High protein energy-restricted

High protein diet, with either low or normal carbohydrate content

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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F NR Van Berkum, MD PhD

Role: STUDY_DIRECTOR

Previtas Hengelo

Locations

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Hospital Hengelo

Hengelo, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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BWO08-002

Identifier Type: -

Identifier Source: org_study_id

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