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CompletedNCT01195610SHOPUSUpdated Nov 25, 2019

Dietary Intervention With Shop Model - SHOPUS

An interventional study of Dietary intervention in Obesity, sponsored by University of Copenhagen. Completed at 1 site in Denmark. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-25.

Sponsored by University of Copenhagen · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
181
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study 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.

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Conditions studied

  • Obesity
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In context

Lead sponsor

University of Copenhagen is the lead sponsor of 450 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • abdominal obesity

Exclusion criteria

Exclusion Criteria:

  • BMI > 45, previous weight change
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
181 participants (actual)

Study arms

  • Experimental
    New Nordic Diet

    New Nordic Diet

    Behavioral: Dietary intervention

  • Experimental
    Average Danish Diet

    Average Danish Diet

    Behavioral: Dietary intervention

Interventions

  • BehavioralDietary intervention

    Instruction to diet for 6 month

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What researchers measure

Primary outcomes

  1. Change in body weight (kg)

    Change in body weight from randomization to end of intervention

    Time frame: 26 weeks

Secondary outcomes

  1. Change in body fat percentage

    Change in body fat percentage (DEXA-scanning)

    Time frame: 26 weeks

  2. Dietary compliance

    Level of dietary compliance

    Time frame: 26 weeks

  3. Changes in components of the metabolic syndrome

    Changes in the number of components of the metabolic syndrome

    Time frame: 26 weeks

  4. Achievement of 5% weight loss

    Achievement of 5% weight loss from randomization to end of intervention

    Time frame: 26 weeks

Other outcomes

  1. Change in gastrointestinal microbial composition

    Diet specific changes in relative abundance of microbial bacteria

    Time frame: 26 weeks

  2. 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 \[proxy for enterotypes\])

    Time frame: 26 weeks

  3. Molecular regulation of glucose homeostasis

    Diet specific molecular regulation in adipose and muscle tissue

    Time frame: 26 weeks

  4. 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

    Time frame: 26 weeks

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Study locations

1 site
  • Department of Human Nutrition
    Frederiksberg, 1958, Denmark
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References and documents

Publications

  • 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. PubMed 24296500 ↗
  • 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;42(2):284. doi: 10.1038/ijo.2018.1. PubMed 28883543 ↗
  • 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. PubMed 26126206 ↗
  • 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. PubMed 24664189 ↗
  • 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. PubMed 24257725 ↗
  • 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. PubMed 32034403 ↗
  • 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. PubMed 30094970 ↗
  • 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. PubMed 28679551 ↗
  • 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. PubMed 27146725 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01195610
Lead sponsor
University of Copenhagen
Responsible party
Thomas Meinert Larsen (Associate professor, University of Copenhagen) — Principal investigator
First posted
Sep 6, 2010
Start date
Aug 2010
Primary completion
Aug 2011
Completion
Jul 2012
Last update
Nov 25, 2019

Study contacts

Thomas Meinert Larsen, PhD
principal investigator · Department of Human Nutrition, University of Copenhagen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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