← Back to Search

Other

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

Must not have

Chronic kidney disease

Children with class 3 obesity (i.e., BMI ≥ 140% of the 95th percentile or BMI ≥ 40.0 kg/m2)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 to 14 weeks

Awards & highlights

No Placebo-Only Group

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.

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).

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 below

Select...

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have chronic kidney disease.

Select...

My child is classified with class 3 obesity.

Select...

I have asthma triggered by exercise.

Select...

I have been diagnosed with type 1 or type 2 diabetes.

Select...

I do not have chronic infections like HIV or hepatitis.

Select...

I have epilepsy.

Select...

I have a bleeding disorder like hemophilia.

Select...

I have an autoimmune disease like lupus or thyroiditis.

Select...

I use my asthma inhaler daily to control my severe asthma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 to 14 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 to 14 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 to 14 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Body mass index (BMI) z-scores

Fat mass index z-scores

Secondary study objectives

Blood pressure percentiles

Fasting plasma triglycerides

Glucose management index

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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.

0 / 11Eligibility criteria met