Dietary Intervention With Shop Model - SHOPUS

NCT01195610 | Completed

• 1 other identifier: B 260
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Change in body weight (kg)

  Change in body weight from randomization to end of intervention

  26 weeks

Secondary Outcomes (4)

• Change in body fat percentage

  26 weeks

• Dietary compliance

  26 weeks

• Changes in components of the metabolic syndrome

  26 weeks

• Achievement of 5% weight loss

  26 weeks

Other Outcomes (4)

• Change in gastrointestinal microbial composition

  26 weeks

• Microbial composition and association with Body weight change

  26 weeks

• Molecular regulation of glucose homeostasis

  26 weeks

Study Arms (2)

New Nordic Diet

EXPERIMENTAL

New Nordic Diet

Behavioral: Dietary intervention

Average Danish Diet

EXPERIMENTAL

Average Danish Diet

Behavioral: Dietary intervention

Interventions

Dietary intervention BEHAVIORAL

Instruction to diet for 6 month

Average Danish Diet; New Nordic Diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• abdominal obesity

You may not qualify if:

• BMI \> 45, previous weight change

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

Department of Human Nutrition

Frederiksberg, 1958, Denmark

Location

Related Publications (9)

• 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.

  PMID: 24296500 BACKGROUND

• 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.

  PMID: 28883543 BACKGROUND

• 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.

  PMID: 26126206 BACKGROUND

• 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 Mar 25.

  PMID: 24664189 RESULT

• 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: 10.3945/ajcn.113.069393. Epub 2013 Nov 20.

  PMID: 24257725 RESULT

• Hjorth MF, Christensen L, Larsen TM, Roager HM, Krych L, Kot W, Nielsen DS, Ritz C, Astrup A. Pretreatment Prevotella-to-Bacteroides ratio and salivary amylase gene copy number as prognostic markers for dietary weight loss. Am J Clin Nutr. 2020 May 1;111(5):1079-1086. doi: 10.1093/ajcn/nqaa007.

  PMID: 32034403 DERIVED

• Acar E, Gurdeniz G, Khakimov B, Savorani F, Korndal SK, Larsen TM, Engelsen SB, Astrup A, Dragsted LO. Biomarkers of Individual Foods, and Separation of Diets Using Untargeted LC-MS-based Plasma Metabolomics in a Randomized Controlled Trial. Mol Nutr Food Res. 2019 Jan;63(1):e1800215. doi: 10.1002/mnfr.201800215. Epub 2018 Aug 26.

  PMID: 30094970 DERIVED

• Hjorth MF, Ritz C, Blaak EE, Saris WH, Langin D, Poulsen SK, Larsen TM, Sorensen TI, Zohar Y, Astrup A. Pretreatment fasting plasma glucose and insulin modify dietary weight loss success: results from 3 randomized clinical trials. Am J Clin Nutr. 2017 Aug;106(2):499-505. doi: 10.3945/ajcn.117.155200. Epub 2017 Jul 5.

  PMID: 28679551 DERIVED

• Khakimov B, Poulsen SK, Savorani F, Acar E, Gurdeniz G, Larsen TM, Astrup A, Dragsted LO, Engelsen SB. New Nordic Diet versus Average Danish Diet: A Randomized Controlled Trial Revealed Healthy Long-Term Effects of the New Nordic Diet by GC-MS Blood Plasma Metabolomics. J Proteome Res. 2016 Jun 3;15(6):1939-54. doi: 10.1021/acs.jproteome.6b00109. Epub 2016 May 20.

  PMID: 27146725 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Thomas Meinert Larsen, PhD

  Department of Human Nutrition, University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: September 3, 2010
• First Posted: September 6, 2010
• Study Start: August 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: July 1, 2012
• Last Updated: November 25, 2019

Record last verified: 2019-11

Locations

DK (1)