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| Name | Class |
|---|---|
| Cargill | INDUSTRY |
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This is an 8 to14-week three-arm randomized controlled in children 8 to 12 years old.
The main purpose of the study is to evaluate if stevia has benefits for weight control and metabolic function relative to caloric sweeteners, and whether it provides benefits in this regard similar to water.
Up to 150 children will be enrolled in the study to achieve a final sample of 90 completers (30 per group). The proposed study will be an 8 to 14-week, three-arm, randomized, controlled, blinded trial in children ages 8 to 12 years from the Central Arkansas region. Children will be randomized to consume one of three beverages: 1) sucrose-sweetened beverage, 2) stevia-sweetened beverage, or 3) calorie-free flavored water beverage. Participants with excessive weight (BMI percentile ≥85th and <140 percent of the 95th percentile) will complete a 14-week intervention whereas normal-weight (BMI percentile <85th) participants will complete an 8-week intervention in parallel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sucrose sweetened beverage | Active Comparator | Sucrose (i.e. sugar): 31.2 g sugar (124.8 Kcal per serving). Participants will be asked to consume the study product once a day for 8 to 14 weeks if they have normal weight or excessive weight, respectively. |
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| Stevia sweetened beverage | Experimental | The stevia-sweetened beverage contains 48.6 mg of steviol equivalents. Participants will be asked to consume the study product once a day for 8 to 14 weeks if they have normal weight or excessive weight, respectively. |
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| Calorie free flavored water beverage | Active Comparator | Flavored water. Participants will be asked to consume the study product once a day for 8 to 14 weeks if they have normal weight or excessive weight, respectively. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sucrose sweetened beverage | Other | Children who habitually consume sugar (sucrose) - sweetened beverages who are randomized to this arm, will consume the study product for 8 to 14 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Body mass index (BMI) z-scores | The change in BMI z-score will be calculated: BMI z-score at completion of the study minus BMI z-score at baseline | Measurements will be obtained at enrollment (baseline) and again at weeks 4 and 8 for all participants. Children with excessive weight will also complete an additional assessment at week 14. |
| Fat mass index z-scores | The change in fat mass index (FMI) z-score will be calculated: FMI z-score at completion of the study minus FMI z-score at baseline. | Measurements will be obtained at enrollment (baseline) and again at weeks 4 and 8 for all participants. Children with excessive weight will also complete an additional assessment at week 14. |
| Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) | HOMA-IR is a unitless estimate of insulin resistance, and it is calculated from fasting glucose and insulin | Measurements will be obtained at enrollment (baseline) and again at weeks 4 and 8 for all participants. Children with excessive weight will also complete an additional assessment at week 14. |
| Fasting plasma lipids (Total cholesterol, HDL-cholesterol, triglycerides, LDL-cholesterol) | Fasting plasma lipids, mg/dl | Measurements will be obtained at enrollment (baseline) and again at weeks 4 and 8 for all participants. Children with excessive weight will also complete an additional assessment at week 14. |
| Blood pressure percentiles | Systolic and diastolic blood pressure percentiles calculated using reference standards from the American Academy of Pediatrics. | Measurements will be obtained at enrollment (baseline) and again at weeks 4 and 8 for all participants. Children with excessive weight will also complete an additional assessment at week 14. |
| Measure | Description | Time Frame |
|---|---|---|
| Gut microbial communities | Shift in gut microbial communities will be assessed using 16S analyses | Measurements will be obtained at enrollment (baseline) and again at week 8 for all participants. Children with excessive weight will also complete an additional assessment at week 14. |
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Inclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eva C Diaz, M.D. | Contact | 5013643056 | ecdiazfuentes@uams.edu | |
| Mario Ferruzzi, Ph.D. | Contact | 5013642781 | MFerruzzi@uams.edu |
| Name | Affiliation | Role |
|---|---|---|
| Eva Diaz, M.D. | Arkansas Children's Nutrition Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Nutrition Center | Recruiting | Little Rock | Arkansas | 72202 | United States |
All study subject materials will be assigned a unique identifying code or number. The key to the code will be kept in a shared network folder with access granted only to study staff who have had appropriate CITI training. Only study investigators/staff will have access to the code and information that identifies the subject in this study. Coded data for all primary and secondary outcomes as well as secondary data analysis will be shared with the Sponsor (Cargill Corporation) using an approved shared folder .
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| Stevia sweetened beverages | Other | Children who habitually consume sugar (sucrose) - sweetened beverages who are randomized to this arm, will consume the study product for 8 to 14 weeks. |
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| Calorie free flavored water beverage | Other | Children who habitually consume sugar (sucrose) - sweetened beverages who are randomized to this arm, will consume the study product for 8 to 14 weeks. |
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| Arkansas Children's Nutrition Center | Recruiting | Little Rock | Arkansas | 72202 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| D015430 | Weight Gain |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D001836 | Body Weight Changes |
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