The Sweet Kids Study (Stevia on Weight and Energy Effect Over Time)

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Sucrose sweetened beverage
  Children who habitually consume sugar (sucrose) - sweetened beverages who are randomized to this arm, will consume the study product for 8 to 14 weeks.
• Другое Stevia sweetened beverages
  Children who habitually consume sugar (sucrose) - sweetened beverages who are randomized to this arm, will consume the study product for 8 to 14 weeks.
• Другое Calorie free flavored water beverage
  Children who habitually consume sugar (sucrose) - sweetened beverages who are randomized to this arm, will consume the study product for 8 to 14 weeks.

Первичные конечные точки

• Body mass index (BMI) z-scores [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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.]

Вторичные конечные точки (1)

• Gut microbial communities [Срок оценки: 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.]

Критерии участия

Критерии включения

• Age 8-12 years
• Normal weight: BMI percentile ≥5th to <85th
• Excessive weight: BMI percentile ≥ 85th and <140% of the 95th percentile or BMI ≥35 to <40 kg/m2
• Current consumption of sugar sweetened beverages (≥2 times /wk)
• Low consumption of non-nutritive sweeteners (≤ 3 time/wk)
• Willingness to consume experimental products Exclusion Criteria
• Children with class 3 obesity (i.e., BMI ≥ 140% of the 95th percentile or BMI ≥ 40.0 kg/m2)
• Dislike of experimental beverage taste (assessed at initial visit)
• Asthma that requires daily use of inhalers to keep symptoms under control.
• Asthma that requires use of rescue inhalers (e.g., albuterol) >2 days per week
• Exercise induced asthma.
• Autism spectrum disorder (e.g., Autistic disorder, Rett disorder, Asperger disorder, childhood disintegrative disorder, pervasive developmental disorder not otherwise specified (PDD-NOS).
• Attention deficit hyperactivity disorder (ADHD) currently under medication.
• Oppositional defiant disorder (ODD).
• Epilepsy.
• Cancer.
• Chronic kidney disease.
• Endocrine disorder (e.g., hypothyroidism and growth hormone deficiency).
• Autoimmune diseases (e.g., lupus, thyroiditis, juvenile idiopathic arthritis)
• Bleeding disorders (e.g., hemophilia)
• Chronic infections (e.g., HIV, hepatitis B, hepatitis C).
• Mental health disorders (e.g., depression and anxiety).
• Type 2 and type 1 diabetes mellitus.
• Other pre-existing medical conditions or medications as determined by the investigators to affect the outcomes of interest.
• If, during the screening or consent process, the parent or child expresses refusal to have blood drawn. However, participants may remain in the study if after initially agreeing to the blood draw and enrolling they change their minds and choose not to allow blood draws or if blood draws are unsuccessful.
• Dislike of study products assessed at initial visit.
• Fasting glucose ≥126 mg/dl at enrollment.
• Fasting A1C ≥6.5% at enrollment
• Less than 2 months since completion of antibiotics

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

США · 2 центра

• Arkansas Children's Nutrition Center — Little Rock
• Arkansas Children's Nutrition Center — Little Rock

Идентификаторы

NCT: NCT05992688 · 275844

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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