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Dietary Intervention With Shop Model - SHOPUS (SHOPUS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01195610
First Posted: September 6, 2010
Last Update Posted: October 31, 2017
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.
Information provided by (Responsible Party):
Thomas Meinert Larsen, University of Copenhagen
September 3, 2010
September 6, 2010
October 31, 2017
August 2010
August 2011   (Final data collection date for primary outcome measure)
Change in body weight (kg) [ Time Frame: 26 weeks ]
Change in body weight from randomization to end of intervention
  • Change in body weight (kg) [ Time Frame: 26 weeks ]
  • Body fat percentage [ Time Frame: 26 weeks ]
  • Dietary compliance level [ Time Frame: 26 weeks ]
  • Components of metabolic syndrome [ Time Frame: 26 weeks ]
Complete list of historical versions of study NCT01195610 on ClinicalTrials.gov Archive Site
  • Change in body fat percentage [ Time Frame: 26 weeks ]
    Change in body fat percentage (DEXA-scanning)
  • Dietary compliance [ Time Frame: 26 weeks ]
    Level of dietary compliance
  • Changes in components of the metabolic syndrome [ Time Frame: 26 weeks ]
    Changes in the number of components of the metabolic syndrome
  • Achievement of 5% weight loss [ Time Frame: 26 weeks ]
    Achievement of 5% weight loss from randomization to end of intervention
Achievement of more than 5 % weight loss [ Time Frame: 26 weeks ]
  • Change in gastrointestinal microbial composition [ Time Frame: 26 weeks ]
    Diet specific changes in relative abundance of microbial bacteria
  • Microbial composition and association with Body weight change [ Time Frame: 26 weeks ]
    Diet specific change in body weight according to relative abundance of microbial bacteria
  • Molecular regulation of glucose homeostasis [ Time Frame: 26 weeks ]
    Diet specific molecular regulation in adipose and muscle tissue
Not Provided
 
Dietary Intervention With Shop Model - SHOPUS
A Six Month Randomized Controlled Dietary Intervention Study of the New Nordic Diet vs Average Danish Diet in Adults (18-65y) Using the Shop Model for Optimal Dietary Adherence
The objective is to investigate whether New Nordic Diet (NND) versus Average Danish Diet (ADD) in adults (18-65 y) with central obesity and components of the metabolic syndrome can improve body weight loss and risk markers of the metabolic syndrome, type 2 diabetes and cardiovascular diseases.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Obesity
Behavioral: Dietary intervention
Instruction to diet for 6 month
  • Experimental: New Nordic Diet
    New Nordic Diet
    Intervention: Behavioral: Dietary intervention
  • Experimental: Average Danish Diet
    Average Danish Diet
    Intervention: Behavioral: Dietary intervention

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
181
July 2012
August 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • abdominal obesity

Exclusion Criteria:

  • BMI > 45, previous weight change
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT01195610
B 260
No
Not Provided
Not Provided
Thomas Meinert Larsen, University of Copenhagen
University of Copenhagen
Not Provided
Principal Investigator: Thomas Meinert Larsen, PhD Department of Human Nutrition, University of Copenhagen
University of Copenhagen
October 2017

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