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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New Nordic Diet | Experimental | New Nordic Diet |
|
| Average Danish Diet | Experimental | Average Danish Diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary intervention | Behavioral | Instruction to diet for 6 month |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight (kg) | Change in body weight from randomization to end of intervention | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body fat percentage | Change in body fat percentage (DEXA-scanning) | 26 weeks |
| Dietary compliance | Level of dietary compliance |
| Measure | Description | Time Frame |
|---|---|---|
| Change in gastrointestinal microbial composition | Diet specific changes in relative abundance of microbial bacteria | 26 weeks |
| 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]) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Meinert Larsen, PhD | Department of Human Nutrition, University of Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Human Nutrition | Frederiksberg | 1958 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24296500 | Background | 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. | |
| 28883543 | Background |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| 26 weeks |
| Changes in components of the metabolic syndrome | Changes in the number of components of the metabolic syndrome | 26 weeks |
| Achievement of 5% weight loss | Achievement of 5% weight loss from randomization to end of intervention | 26 weeks |
| 26 weeks |
| Molecular regulation of glucose homeostasis | Diet specific molecular regulation in adipose and muscle tissue | 26 weeks |
| 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 |
| 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. |
| 26126206 | 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. |
| 24664189 | Result | 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. |
| 24257725 | 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. |
| 32034403 | Derived | 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. |
| 30094970 | 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. |
| 28679551 | 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. |
| 27146725 | 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. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |