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Dietary Supplement

Carbohydrate Diets for Childhood Obesity

Q: What is the upper limit of participants in this clinical trial?

Affirmative. The information available on clinicaltrials.gov confirms that the clinical trial, initially posted on May 1st 2018, is still actively recruiting patients from a single location and has set an objective of 100 participants.

Q: Are geriatric individuals being considered as participants of this experimental research?

To join this trial, participants must be between 15 and 21 years old.

Q: Does this trial have vacancies for participants?

This trial, with its debut on May 1st 2018 and last update November 1st 2022, is currently searching for suitable candidates according to clinicaltrials.gov.

Q: Is it feasible for me to join this clinical trial?

This research initiative is looking for 100 participants between the ages of 15 and 21 who have been clinically diagnosed with <a href="https://www.withpower.com/clinical-trials/obesity">obesity</a>. Specifically, those in the lean cohort must present a body mass index that falls above 25th percentile and below 85th percentile; individuals in the obese cohort should demonstrate a BMI above 95th percentile. Additionally, female candidates need to provide proof that they are not pregnant during their time participating in this trial. <a href="https://www.withpower.com/clinical-trials/all">All</a> potential study members must be generally healthy and cannot take any form of chronic medication throughout it's duration.

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 hours

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 hours

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,862 Previous Clinical Trials

2,742,468 Total Patients Enrolled

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,369 Previous Clinical Trials

4,316,497 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit of participants in this clinical trial?

"Affirmative. The information available on clinicaltrials.gov confirms that the clinical trial, initially posted on May 1st 2018, is still actively recruiting patients from a single location and has set an objective of 100 participants."

Answered by AI

Are geriatric individuals being considered as participants of this experimental research?

"To join this trial, participants must be between 15 and 21 years old."

Answered by AI

Does this trial have vacancies for participants?

"This trial, with its debut on May 1st 2018 and last update November 1st 2022, is currently searching for suitable candidates according to clinicaltrials.gov."

Answered by AI

Is it feasible for me to join this clinical trial?

"This research initiative is looking for 100 participants between the ages of 15 and 21 who have been clinically diagnosed with obesity. Specifically, those in the lean cohort must present a body mass index that falls above 25th percentile and below 85th percentile; individuals in the obese cohort should demonstrate a BMI above 95th percentile. Additionally, female candidates need to provide proof that they are not pregnant during their time participating in this trial. All potential study members must be generally healthy and cannot take any form of chronic medication throughout it's duration."

Answered by AI

Recent research and studies

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Effect of Gut Microbiota and pnpla3 Rs738409 Variant on Nonalcoholic Fatty Liver Disease (NAFLD) in Obese Youth

Monga Kravetz, Ayesha, Todd Testerman, Brittany Galuppo, Joerg Graf, Bridget Pierpont, Stephan Siebel, Richard Feinn, and Nicola Santoro. 2020. “Effect of Gut Microbiota and pnpla3 Rs738409 Variant on Nonalcoholic Fatty Liver Disease (NAFLD) in Obese Youth”. The Journal of Clinical Endocrinology & Metabolism. The Endocrine Society. doi:10.1210/clinem/dgaa382.

The Journal of NutritionJournal

Colonic Fermentation and Acetate Production in Youth with and Without Obesity

Galuppo, Brittany, Gary Cline, Michelle Van Name, Veronika Shabanova, David Wagner, C Lawrence Kien, and Nicola Santoro. 2021. “Colonic Fermentation and Acetate Production in Youth with and Without Obesity”. The Journal of Nutrition. Oxford University Press (OUP). doi:10.1093/jn/nxab277.

The Journal of NutritionJournal

Colonic Fermentation and Acetate Production in Youth with and Without Obesity

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Mechanisms of Obesity and Its Metabolic Complications in Youth