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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
B.H.R. Wolffenbuttel, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT00862953
First received: March 16, 2009
Last updated: February 19, 2012
Last verified: February 2012
History of Changes

March 16, 2009
February 19, 2012
July 2008
May 2010   (final data collection date for primary outcome measure)
Body weight [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00862953 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study to Assess the Effects of High Protein Diet in Obesity, the LOWER Study
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.

Assessment focuses on the effect of the specific diets on weight reduction after 3 months, and weight maintenance after 12 months.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Obesity
  • Dietary Supplement: Normal protein energy-restricted
    Normal protein diet energy restricted
  • Dietary Supplement: High protein energy-restricted
    High protein diet, with either low or normal carbohydrate content
  • Active Comparator: Normal protein normal carbohydrate
    Normal protein normal carbohydrate calory restricted nutrition
    Intervention: Dietary Supplement: Normal protein energy-restricted
  • Experimental: Normal protein low carbohydrates
    Normal protein low carbohydrate energy-restricted diet
    Intervention: Dietary Supplement: Normal protein energy-restricted
  • Experimental: High protein normal carbohydrates
    High protein normal carbohydrates
    Intervention: Dietary Supplement: High protein energy-restricted
  • Experimental: High protein low carbohydrate
    High protein low carbohydrate nutrition
    Intervention: Dietary Supplement: High protein energy-restricted
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
317
October 2010
May 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00862953
BWO08-002
No
B.H.R. Wolffenbuttel, University Medical Centre Groningen
B.H.R. Wolffenbuttel
Not Provided
Study Director: F NR Van Berkum, MD PhD Previtas Hengelo
University Medical Centre Groningen
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP