Clinical trial NCT01195610: Dietary Intervention With Shop Model - 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2010-09-06
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* abdominal obesity

Exclusion Criteria:

* BMI \> 45, previous weight change

Primary outcomes:
measure: Change in body weight (kg)
timeFrame: 26 weeks
Secondary outcomes:
measure: Change in body fat percentage
timeFrame: 26 weeks
measure: Dietary compliance
timeFrame: 26 weeks
measure: Changes in components of the metabolic syndrome
timeFrame: 26 weeks
measure: Achievement of 5% weight loss
timeFrame: 26 weeks
Other outcomes:
measure: Change in gastrointestinal microbial composition
timeFrame: 26 weeks
measure: Microbial composition and association with Body weight change
timeFrame: 26 weeks
measure: Molecular regulation of glucose homeostasis
timeFrame: 26 weeks
measure: Human salivary amylase gene copy number (AMY1 CN) and association with Body weight change [ Time Frame: 26 weeks ]
timeFrame: 26 weeks
Locations:
city: Frederiksberg
country: Denmark
facility: Department of Human Nutrition
Study officials:
affiliation: Department of Human Nutrition, University of Copenhagen
name: Thomas Meinert Larsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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 Mar 25.
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: 10.3945/ajcn.113.069393. Epub 2013 Nov 20.
citation: 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.
citation: 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.
citation: 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.
citation: 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.