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Stevia for Childhood Obesity
N/A
Recruiting
Research Sponsored by Arkansas Children's Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Excessive weight: BMI percentile ≥ 85th and <140% of the 95th percentile or BMI ≥35 to <40 kg/m2
Age 8-12 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 to 14 weeks
Awards & highlights
Study Summary
This trial will test if stevia can help kids 8-12 manage their weight and metabolism better than other sugar substitutes or water.
Who is the study for?
The Sweet Kids Study is for children aged 8-12 who regularly drink sugary beverages and are either of normal weight or overweight, but not severely obese. They should be willing to try new drinks and not have conditions like diabetes, chronic infections, hormonal diseases, severe asthma, bleeding disorders, certain mental health issues or a recent history of antibiotic use.Check my eligibility
What is being tested?
This study compares the effects of three types of beverages on children's weight and metabolic function over an 8 to14-week period: water flavored without calories, drinks sweetened with stevia (a no-calorie sweetener), and drinks sweetened with regular sugar (sucrose).See study design
What are the potential side effects?
While the trial does not specifically list side effects related to the beverages being tested (water, stevia-sweetened beverage, sucrose-sweetened beverage), potential concerns may include digestive changes due to different sweeteners or reactions in kids sensitive to taste changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My BMI is high, between 35 and less than 40, or it's in the top 15% for my age.
Select...
I am between 8 and 12 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 to 14 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 to 14 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Body mass index (BMI) z-scores
Fat mass index z-scores
Secondary outcome measures
Blood pressure percentiles
Fasting plasma triglycerides
Glucose management index
+4 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Stevia sweetened beverageExperimental Treatment1 Intervention
The stevia-sweetened beverage contains 30.1 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.
Group II: Calorie free flavored water beverageActive Control1 Intervention
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.
Group III: Sucrose sweetened beverageActive Control1 Intervention
Sucrose (i.e. sugar): 25 g sugar (100 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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Who is running the clinical trial?
CargillIndustry Sponsor
26 Previous Clinical Trials
2,979 Total Patients Enrolled
5 Trials studying Obesity
1,402 Patients Enrolled for Obesity
Arkansas Children's Hospital Research InstituteLead Sponsor
135 Previous Clinical Trials
5,029,155 Total Patients Enrolled
6 Trials studying Obesity
10,460 Patients Enrolled for Obesity
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have chronic kidney disease.You have a body mass index (BMI) between the 5th and 85th percentile for your age and gender.My child is classified with class 3 obesity.I have asthma triggered by exercise.You rarely use artificial sweeteners (less than 3 times per week).You have been diagnosed with oppositional defiant disorder (ODD).My BMI is high, between 35 and less than 40, or it's in the top 15% for my age.I have a diagnosed mental health condition like depression or anxiety.You have a diagnosis of autism spectrum disorder, such as autistic disorder or Asperger disorder.You have other health conditions or take medications that could change the study results.I have a hormonal condition like hypothyroidism.I am willing to try new treatment options.I have been diagnosed with type 1 or type 2 diabetes.I do not have chronic infections like HIV or hepatitis.I have epilepsy.Your A1C level is higher than 6.5% when you haven't eaten for a while.You finished taking antibiotics less than 2 months ago.You drink sugary drinks three or more times a week.Your blood sugar level when you haven't eaten for a while is higher than 126 mg/dl.I have a bleeding disorder like hemophilia.I have an autoimmune disease like lupus or thyroiditis.I do not like the taste of the experimental beverage.I am between 8 and 12 years old.I use my asthma inhaler daily to control my severe asthma.You have been diagnosed with attention deficit hyperactivity disorder (ADHD).
Research Study Groups:
This trial has the following groups:- Group 1: Calorie free flavored water beverage
- Group 2: Sucrose sweetened beverage
- Group 3: Stevia sweetened beverage
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research study open to elderly participants above the age of eighty-five?
"This clinical trial's eligibility requirements specify that all participants must be between 8 and 12 years of age."
Answered by AI
Am I eligible to be a part of this clinical investigation?
"This medical trial seeks to recruit a total of 210 children between the ages 8 and 12 suffering from obesity."
Answered by AI
Does this research endeavor still have volunteer openings?
"Contrary to what is hosted on clinicaltrials.gov, this medical study is not currently enrolling patients; as it was initially published in November 1st 2023 and last updated August 8th 2023. Nevertheless, the website does feature over nine hundred ninety-three other trials that are actively searching for volunteers."
Answered by AI
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