Skip to main content
OpenTrials
Completed

NCT Number: NCT01195610

Dietary Intervention With Shop Model - SHOPUS

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Human Nutrition

Frederiksberg, 1958, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • abdominal obesity

Exclusion criteria

  • BMI > 45, previous weight change

Treatment and study plan

Dietary intervention

Behavioral

Instruction to diet for 6 month

Primary outcomes

  1. Change in body weight (kg)

    Time frame: 26 weeks

    Change in body weight from randomization to end of intervention

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Official study 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

Acronym: SHOPUS

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Sep 6, 2010
Registry last updated
Nov 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.