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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01195610
Acronym
SHOPUS
Enrollment
181
Registered
2010-09-06
Start date
2010-08-31
Completion date
2012-07-31
Last updated
2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

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.

Interventions

BEHAVIORALDietary intervention

Instruction to diet for 6 month

Sponsors

University of Copenhagen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* abdominal obesity

Exclusion criteria

* BMI \> 45, previous weight change

Design outcomes

Primary

MeasureTime frameDescription
Change in body weight (kg)26 weeksChange in body weight from randomization to end of intervention

Secondary

MeasureTime frameDescription
Change in body fat percentage26 weeksChange in body fat percentage (DEXA-scanning)
Dietary compliance26 weeksLevel of dietary compliance
Changes in components of the metabolic syndrome26 weeksChanges in the number of components of the metabolic syndrome
Achievement of 5% weight loss26 weeksAchievement of 5% weight loss from randomization to end of intervention

Other

MeasureTime frameDescription
Microbial composition and association with Body weight change26 weeksDiet specific change in body weight according to relative abundance of microbial bacteria, e.g., baseline Prevotella/Bacteroides ratio \[proxy for enterotypes\])
Molecular regulation of glucose homeostasis26 weeksDiet specific molecular regulation in adipose and muscle tissue
Human salivary amylase gene copy number (AMY1 CN) and association with Body weight change [ Time Frame: 26 weeks ]26 weeksDiet specific change in body weight according to AMY1 CN
Change in gastrointestinal microbial composition26 weeksDiet specific changes in relative abundance of microbial bacteria

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026