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Dietary Supplement

Carbohydrate Diets for Childhood Obesity

N/A
Recruiting
Led By Nicola Santoro, Phd,MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 15 to 21 years
In puberty (girls and boys: Tanner stage III - V)
Must not have
Presence of endocrinopathies (e.g. Cushing syndrome)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 hours
Awards & highlights

Summary

This trial is testing whether gut bacteria affects people's metabolism by producing short chain fatty acids, which may then influence lipid metabolism.

Who is the study for?
This trial is for youths aged 15-21 in puberty (Tanner stage III-V) with a BMI >25th and <85th percentile for the lean group, or >95th percentile for the obese group. Participants should be in good health, not on chronic medication, and girls must test negative for pregnancy.
What is being tested?
The study aims to understand how gut bacteria affect metabolism through substances called short chain fatty acids (SCFA), and if SCFAs can influence fat metabolism. It involves comparing diets high in carbohydrates among obese and lean young individuals.
What are the potential side effects?
Since this trial focuses on dietary interventions rather than medications, side effects may include gastrointestinal discomfort or changes in bowel habits due to alterations in diet composition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 15 and 21 years old.
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I am in the middle to late stages of puberty.
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I am a girl who has started menstruating and will take a pregnancy test if required.
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I am not on any long-term medications.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a hormone disorder like Cushing syndrome.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
For an equal amount of dietary carbohydrates, obese youth will synthesize short chain fatty acids at higher rates than lean youth.
If high rates of short chain fatty acid (SCFA) synthesis enhance hepatic de novo lipogenesis.
The effect of an isocaloric low carbohydrate (CHO) diet on the bacterial synthesis of short chain fatty acids (SCFA).

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: obese carbohydrate dietExperimental Treatment1 Intervention
Obese adolescents with a body mass index (BMI) \>95th percentile.
Group II: lean carbohydrate dietActive Control1 Intervention
Lean adolescents with a body mass index (BMI) \<85th percentile.

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,907 Previous Clinical Trials
3,018,949 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,410 Previous Clinical Trials
4,324,791 Total Patients Enrolled
Nicola Santoro, Phd,MDPrincipal InvestigatorYale University

Media Library

Lean Carbohydrate Diet (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT03454828 — N/A
Childhood Obesity Research Study Groups: obese carbohydrate diet, lean carbohydrate diet
Childhood Obesity Clinical Trial 2023: Lean Carbohydrate Diet Highlights & Side Effects. Trial Name: NCT03454828 — N/A
Lean Carbohydrate Diet (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03454828 — N/A
~3 spots leftby Dec 2024
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