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Trial record 1 of 1 for:    nct01195610 | Completed Studies | Denmark
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Dietary Intervention With Shop Model - SHOPUS (SHOPUS)

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ClinicalTrials.gov Identifier: NCT01195610
Recruitment Status : Completed
First Posted : September 6, 2010
Last Update Posted : November 25, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas Meinert Larsen, University of Copenhagen

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Dietary intervention Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 181 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : July 2012
Arms and Interventions
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Arm Intervention/treatment
Experimental: New Nordic Diet
New Nordic Diet
 Behavioral: Dietary intervention
Instruction to diet for 6 month
Experimental: Average Danish Diet
Average Danish Diet
 Behavioral: Dietary intervention
Instruction to diet for 6 month


Outcome Measures
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Primary Outcome Measures :
  1. Change in body weight (kg) [ Time Frame: 26 weeks ]
    Change in body weight from randomization to end of intervention


Secondary Outcome Measures :
  1. Change in body fat percentage [ Time Frame: 26 weeks ]
    Change in body fat percentage (DEXA-scanning)

  2. Dietary compliance [ Time Frame: 26 weeks ]
    Level of dietary compliance

  3. Changes in components of the metabolic syndrome [ Time Frame: 26 weeks ]
    Changes in the number of components of the metabolic syndrome

  4. Achievement of 5% weight loss [ Time Frame: 26 weeks ]
    Achievement of 5% weight loss from randomization to end of intervention


Other Outcome Measures:
  1. Change in gastrointestinal microbial composition [ Time Frame: 26 weeks ]
    Diet specific changes in relative abundance of microbial bacteria

  2. 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, e.g., baseline Prevotella/Bacteroides ratio [proxy for enterotypes])

  3. Molecular regulation of glucose homeostasis [ Time Frame: 26 weeks ]
    Diet specific molecular regulation in adipose and muscle tissue

  4. Human salivary amylase gene copy number (AMY1 CN) and association with Body weight change [ Time Frame: 26 weeks ] [ Time Frame: 26 weeks ]
    Diet specific change in body weight according to AMY1 CN


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • abdominal obesity

Exclusion Criteria:

  • BMI > 45, previous weight change
Contacts and Locations
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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): NCT01195610


Locations
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Denmark
Department of Human Nutrition
Frederiksberg, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
Investigators
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Principal Investigator: Thomas Meinert Larsen, PhD Department of Human Nutrition, University of Copenhagen
More Information
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Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Thomas Meinert Larsen, Associate professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01195610    
Other Study ID Numbers: B 260
First Posted: September 6, 2010    Key Record Dates
Last Update Posted: November 25, 2019
Last Verified: November 2019