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

April 16, 2024 updated by: University Medical Center Groningen

The Lifestyle, OverWeight, Energy Restriction Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

317

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Normal protein normal carbohydrate
Normal protein normal carbohydrate calory restricted nutrition
Dietary supplement: Normal protein energy-restricted
Normal protein diet energy restricted
Experimental: Normal protein low carbohydrates
Normal protein low carbohydrate energy-restricted diet
Dietary supplement: Normal protein energy-restricted
Normal protein diet energy restricted
Experimental: High protein normal carbohydrates
Dietary supplement: High protein energy-restricted
High protein diet, with either low or normal carbohydrate content
Experimental: High protein low carbohydrate
High protein low carbohydrate nutrition
Dietary supplement: High protein energy-restricted
High protein diet, with either low or normal carbohydrate content

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body weight
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Investigators

  • Study Director: F NR Van Berkum, MD PhD, Previtas Hengelo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

March 16, 2009

First Submitted That Met QC Criteria

March 16, 2009

First Posted (Estimated)

March 17, 2009

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BWO08-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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