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| ID | Type | Description | Link |
|---|---|---|---|
| H-20059243 | Registry Identifier | Danish Ethical Committee |
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| Name | Class |
|---|---|
| Arla Foods | INDUSTRY |
| University of Aarhus | OTHER |
| Mælkeafgiftsfonden | UNKNOWN |
| University of Copenhagen |
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The study will be conducted as a randomized controlled trial with four parallel arms including four dairy products. We will investigate the health effects of including yogurt in the diet through a 16-weeks intervention period among 100 volunteering males with symptoms of the metabolic syndrome. The study has a total duration of 20 weeks as a wash out period of four weeks will be initiated prior to the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regular whole milk | Active Comparator | Substitution of a part of the habitual diet with 400 g/day of regular whole milk |
|
| Yogurt with live bacteria | Experimental | Substitution of a part of the habitual diet with 400 g/day of yogurt with life bacteria |
|
| Yogurt with inactivated bacteria | Experimental | Substitution of a part of the habitual diet with 400 g/day of yogurt with inactivated bacteria |
|
| Acidified whole milk | Experimental | Substitution of a part of the habitual diet with 400 g/day of acidified whole milk |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regular whole milk | Dietary Supplement | 400 g/day of regular whole milk |
|
| Measure | Description | Time Frame |
|---|---|---|
| Liver fat | Measurements of liver fat by Magnetic Resonance Imaging | Change from Week 0 to week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiometabolic risk | Measured by fasting cholesterol, HDL, LDL, Triglycerid and LDL fractions | Change from Week 0 to week 16 |
| Cardiometabolic risk | Measured by fasting ALAT |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolome | Measurement of metabolomic markers in blood, urine and feces | Change from week -4 to week 16 |
| Physical activity | Measured by International Physical Activity Questionnaire (IPAQ) |
Inclusion Criteria:
Exclusion Criteria:
Based on self-representation of gender identity
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| Name | Affiliation | Role |
|---|---|---|
| Faidon Magkos, PhD | University of Copenhagen, Department of Nutrition, Exercise and Sports | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Copenhagen, Department of Nutrition, Exercise and Sports | Frederiksberg | DK | 1958 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38299443 | Derived | Correia BSB, Sandby K, Krarup T, Magkos F, Geiker NRW, Bertram HC. Changes in Plasma, Urine, and Fecal Metabolome after 16 Weeks of Consuming Dairy With Different Food Matrixes - A Randomized Controlled Trial. Mol Nutr Food Res. 2024 Mar;68(5):e2300363. doi: 10.1002/mnfr.202300363. Epub 2024 Feb 1. | |
| 38232682 | Derived |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D024821 | Metabolic Syndrome |
| D005234 | Fatty Liver |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D003611 | Dairy Products |
| D008892 | Milk |
| D015014 | Yogurt |
| D043302 | Cultured Milk Products |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| OTHER |
16-week parallel randomized controlled trial
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Until the statistical analyses are performed, principal investigator and statistician are blinded
| Yogurt with live bacteria | Dietary Supplement | 400 g/day of yogurt with live bacteria |
|
|
| Yogurt with inactivated bacteria | Dietary Supplement | 400 g/day of yogurt with inactivated bacteria |
|
|
| Acidified whole milk | Dietary Supplement | 400 g/day of yogurt with acidified whole milk |
|
|
| Change from Week 0 to week 16 |
| Cardiometabolic risk | Measured by fasting blood pressure (automatic device) | Change from Week 0 to week 16 |
| Gut microbiome | Measurments of microbiota (fecal spot samples) | Change from week -4 to week 16 |
| Glucose metabolism (fasting samples) | Measurements of fasting glucose, insulin, C-peptide, HbA1C | Change from Week 0 to week 16 |
| Glucose metabolism (5 hour oral glucose tolerance test) | Measurements of glucose, insulin and C-peptide during a 5 hour oral glucose tolerance test | Week 16 (5 hour test) |
| Inflammation | Measurements of fasting CRP | Change from Week 0 to week 16 |
| Inflammation | Measurements of fasting IL-6 | Change from Week 0 to week 16 |
| Inflammation | Measurements of fasting TNF-alfa | Change from Week 0 to week 16 |
| Body composition | Measurements of body weight (every week), height (stadiometer) (only at screening), waist and hip circumference (non-elastic tape), sagittal diameter (abdominal caliper) (only week 0 and 16) as wells as fat mass and fat free mass (whole body DXA scan) (only week 0 and 16). | Change from week -4 to week 16 |
| Fat disposition and pancreatic fat | Measurements of viceral, subcutaneous and pancreatic fat by Magnetic Resonance Imaging | Change from Week 0 to week 16 |
| Change from week -4 to week 16 |
| Sleep quality | Measured by Pittsburg Sleep Quality Index (PSQI) | Change from week -4 to week 16 |
| Perceived stress | Measured by Perceived Stress Scale (PSS) | Change from week -4 to week 16 |
| Life quality | Measured by Physical and mental life quality, Short Form-36 (SF-36) | Change from week -4 to week 16 |
| The influence of initial glucose metabolism | Statistical investigation of the effect of initial glucose metabolism on liver fat | Change from week -4 to week 16 |
| The influence of initial gut microbiota | Statistical investigation of the effect of initial microbiota assessed by fecal sample on liver fat | Change from week -4 to week 16 |
| The influence of initial body composition | Statistical investigation of the effect of initial body composition assessed by DXA scan on liver fat | Change from week -4 to week 16 |
| Sandby K, Magkos F, Chabanova E, Petersen ET, Krarup T, Bertram HC, Kristiansen K, Geiker NRW. The effect of dairy products on liver fat and metabolic risk markers in males with abdominal obesity - a four-arm randomized controlled trial. Clin Nutr. 2024 Feb;43(2):534-542. doi: 10.1016/j.clnu.2023.12.018. Epub 2023 Dec 27. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D001628 |
| Beverages |
| D000074421 | Fermented Foods |