Dietary Intervention With Shop Model - SHOPUS

Obesity Clinical Trial

— SHOPUS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01195610
• Other study ID #: B 260
• Status: Completed
• Phase: N/A
• Start date: August 2010
• Est. completion date: July 2012

Study information

• Verified date: November 2019
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: July 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• abdominal obesity

Exclusion Criteria:

• BMI > 45, previous weight change

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Dietary intervention
Instruction to diet for 6 month

Locations

Country	Name	City	State
Denmark	Department of Human Nutrition	Frederiksberg

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

References & Publications (5)

Fritzen AM, Lundsgaard AM, Jordy AB, Poulsen SK, Stender S, Pilegaard H, Astrup A, Larsen TM, Wojtaszewski JF, Richter EA, Kiens B. New Nordic Diet-Induced Weight Loss Is Accompanied by Changes in Metabolism and AMPK Signaling in Adipose Tissue. J Clin Endocrinol Metab. 2015 Sep;100(9):3509-19. doi: 10.1210/jc.2015-2079. Epub 2015 Jun 30. — View Citation

Hjorth MF, Roager HM, Larsen TM, Poulsen SK, Licht TR, Bahl MI, Zohar Y, Astrup A. Pre-treatment microbial Prevotella-to-Bacteroides ratio, determines body fat loss success during a 6-month randomized controlled diet intervention. Int J Obes (Lond). 2018 Mar;42(3):580-583. doi: 10.1038/ijo.2017.220. Epub 2017 Sep 8. Erratum in: Int J Obes (Lond). 2018 Feb 06;:. — View Citation

Poulsen SK, Crone C, Astrup A, Larsen TM. Long-term adherence to the New Nordic Diet and the effects on body weight, anthropometry and blood pressure: a 12-month follow-up study. Eur J Nutr. 2015 Feb;54(1):67-76. doi: 10.1007/s00394-014-0686-z. Epub 2014 — View Citation

Poulsen SK, Due A, Jordy AB, Kiens B, Stark KD, Stender S, Holst C, Astrup A, Larsen TM. Health effect of the New Nordic Diet in adults with increased waist circumference: a 6-mo randomized controlled trial. Am J Clin Nutr. 2014 Jan;99(1):35-45. doi: 10.3 — View Citation

Roager HM, Licht TR, Poulsen SK, Larsen TM, Bahl MI. Microbial enterotypes, inferred by the prevotella-to-bacteroides ratio, remained stable during a 6-month randomized controlled diet intervention with the new nordic diet. Appl Environ Microbiol. 2014 Feb;80(3):1142-9. doi: 10.1128/AEM.03549-13. Epub 2013 Dec 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in gastrointestinal microbial composition	Diet specific changes in relative abundance of microbial bacteria	26 weeks
Other	Microbial composition and association with Body weight change	Diet specific change in body weight according to relative abundance of microbial bacteria, e.g., baseline Prevotella/Bacteroides ratio [proxy for enterotypes])	26 weeks
Other	Molecular regulation of glucose homeostasis	Diet specific molecular regulation in adipose and muscle tissue	26 weeks
Other	Human salivary amylase gene copy number (AMY1 CN) and association with Body weight change [ Time Frame: 26 weeks ]	Diet specific change in body weight according to AMY1 CN	26 weeks
Primary	Change in body weight (kg)	Change in body weight from randomization to end of intervention	26 weeks
Secondary	Change in body fat percentage	Change in body fat percentage (DEXA-scanning)	26 weeks
Secondary	Dietary compliance	Level of dietary compliance	26 weeks
Secondary	Changes in components of the metabolic syndrome	Changes in the number of components of the metabolic syndrome	26 weeks
Secondary	Achievement of 5% weight loss	Achievement of 5% weight loss from randomization to end of intervention	26 weeks