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| Name | Class |
|---|---|
| LG Life Sciences | INDUSTRY |
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Compared to solid foods, the nutritional energy of drinks may bypass the appetite regulation leading to obesity development. Although drinks sweetened with aspartame are available the anticipated positive effect of these drinks on obesity development has not been convincing. However, the mechanisms linking drinks intake to obesity are yet to be clarified.
The investigators aim is to investigate the long-term effects of intake of soft drinks, milk and water. The study is a parallel, intervention trial with 80 overweight, healthy volunteers. They will be randomly selected to drink one liter a day of one of the four drinks for six months. The objectives are changes in numerous circulating metabolic risk factors, changes in body weight, anthropometric data and fat distribution (measured by DEXA, MRI and MR-spectroscopy).
The investigators expect to clarify the mechanisms linking drinking habits to obesity development and provide scientifically based nutritional guidelines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugar-sweetened soft drink | Experimental | 54g sugar/L, 180kJ/100mL |
|
| Aspartame-sweetened soft drink | Experimental | 1.5kJ/100mL |
|
| Semi-skimmed milk | Active Comparator | 202kJ/100mL |
|
| Water | Placebo Comparator | 0kJ/100mL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugar-sweetened soft drink | Other | One litre a day for six months. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight (kg) | Six months | |
| MR spectroscopy | to assess liver fat and skeletal muscle fat | Six months |
| Magnetic resonance imaging | to assess visceral adipose tissue (VAT) and subcutaneous abdominal adipose tissue (SAAT) | Six months |
| Dual-energy X-ray absorptiometry (DEXA) scan | to assess total fat mass (kg), lean body mass (kg), and bone mass (kg) | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | Systolic and diastolic blood pressure (mmHg) | Six months |
| Circulating metabolic parameters: including serum urate | mmol/L |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bjørn Richelsen, Professor | Department of Internal Medicine/Endocrinology C, Aarhus University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Internal Medicine/Endocrinology C, Aarhus University Hospital | Aarhus | 8000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36118751 | Derived | Bajahzer MF, Bruun JM, Rosqvist F, Marklund M, Richelsen B, Riserus U. Effects of sugar-sweetened soda on plasma saturated and monounsaturated fatty acids in individuals with obesity: A randomized study. Front Nutr. 2022 Aug 31;9:936828. doi: 10.3389/fnut.2022.936828. eCollection 2022. | |
| 26081486 | Derived | Bruun JM, Maersk M, Belza A, Astrup A, Richelsen B. Consumption of sucrose-sweetened soft drinks increases plasma levels of uric acid in overweight and obese subjects: a 6-month randomised controlled trial. Eur J Clin Nutr. 2015 Aug;69(8):949-53. doi: 10.1038/ejcn.2015.95. Epub 2015 Jun 17. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D005247 | Feeding Behavior |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000080845 | Sugar-Sweetened Beverages |
| D018752 | Diet, Fat-Restricted |
| D014867 | Water |
| ID | Term |
|---|---|
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Aspartame-sweetened soft drink |
| Other |
One litre a day for six months. |
|
| Semi-skimmed milk | Other | One litre a day for six months |
|
| Water | Other | One litre a day for six months. |
|
| Six months |
| fasting plasma glucose | mmol/L | Six months |
| fasting serum insulin | pmol/L | Six months |
| Oral Glucose Tolerance Test (OGTT) | AUC OGTT glucose and insulin, AUC HOMA-IR, and Matzuda index | Six months |
| Fasting blood lipids | Total, LDL, and HDL cholesterol, and TAG (mmol/L) | Six months |
| Fasting plasma FFA | mmol/L | Six months |
| Fasting plasma PAI-1 | ng/ml | Six months |
| 22205311 | Derived | Maersk M, Belza A, Stodkilde-Jorgensen H, Ringgaard S, Chabanova E, Thomsen H, Pedersen SB, Astrup A, Richelsen B. Sucrose-sweetened beverages increase fat storage in the liver, muscle, and visceral fat depot: a 6-mo randomized intervention study. Am J Clin Nutr. 2012 Feb;95(2):283-9. doi: 10.3945/ajcn.111.022533. Epub 2011 Dec 28. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001522 | Behavior, Animal |
| D001519 | Behavior |
| D004035 |
| Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |