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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00862953
Recruitment Status : Completed
First Posted : March 17, 2009
Last Update Posted : February 22, 2012
Sponsor:
Information provided by (Responsible Party):
B.H.R. Wolffenbuttel, University Medical Center Groningen

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Normal protein energy-restricted Dietary Supplement: High protein energy-restricted Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 317 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Lifestyle, OverWeight, Energy Restriction Study
Study Start Date : July 2008
Actual Primary Completion Date : May 2010
Actual Study Completion Date : October 2010

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
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




Primary Outcome Measures :
  1. Body weight [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00862953


Locations
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Netherlands
Hospital Hengelo
Hengelo, Netherlands
Sponsors and Collaborators
B.H.R. Wolffenbuttel
Investigators
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Study Director: F NR Van Berkum, MD PhD Previtas Hengelo
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Responsible Party: B.H.R. Wolffenbuttel, Head of Dept, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT00862953    
Other Study ID Numbers: BWO08-002
First Posted: March 17, 2009    Key Record Dates
Last Update Posted: February 22, 2012
Last Verified: February 2012
Keywords provided by B.H.R. Wolffenbuttel, University Medical Center Groningen:
low carbohydrate
high protein diet
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight