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This study will investigate how some artificial sweeteners (AS) cross from blood to breastmilk in breastfeeding women after oral intake. Moreover, it will be investigated whether the kinetics of AS differ based on the women's body composition (BMI) and metabolic status (diabetes). This will be investigated through a clinical trial in which 60 women divided into three groups (normal weight, overweight and diabetic) will drink a beverage containing four AS. over a period of six hours the women will donate blood and breast milk samples in order to investigate the presence of AS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention groups | Experimental | The participants will be given a beverage containing four artificial sweeteners (intervention) at baseline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artificial sweeteners (acesulfame-potassium, sucralose, saccharine, cyclamate) | Dietary Supplement | The intervention is found in light products ingested by millions of people on a daily basis worldwide |
| Measure | Description | Time Frame |
|---|---|---|
| Breastmilk from mother | Concentration of artificial sweeteners in mother's breast milk | Baseline, after 30 mins and afterwards once and hour for six hours |
| Blood from mother | Concentration of artificial sweeteners in mother's blood | Baseline, after 30 mins and afterwards once and hour for six hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | 8000 | Denmark |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| D003920 | Diabetes Mellitus |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D013549 | Sweetening Agents |
| C006362 | acetosulfame |
| C026285 | trichlorosucrose |
| D003494 | Cyclamates |
| ID | Term |
|---|---|
| D005421 | Flavoring Agents |
| D005503 | Food Additives |
| D000074385 | Food Ingredients |
| D020313 | Specialty Uses of Chemicals |
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60 women will be divided into three groups (n=20 each) based on pre-pregnancy BMI and metabolic status.
The groups are
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All participants are given the same intervention and are aware of this
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| D009750 |
| Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020164 |
| Chemical Actions and Uses |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |