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NCT02857543 · ClinicalTrials.gov registry record · NA

Plant-Based, American Heart Assoc. or Mediterranean Diets In 9-18 yo With BMI >95%, Cholesterol >169 and Their Parents

A NA study, sponsored by The Cleveland Clinic.

Completed
Registry status
NA
Development phase
180
Enrollment target

NCT02857543: Completed NA study, sponsored by The Cleveland Clinic.

NCT02857543 is a NA study that has completed, run by The Cleveland Clinic. The registered enrollment target is 180 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02857543, a NA study, has completed, sponsored by The Cleveland Clinic.

COMPLETED
Registry status
NA
Development phase
180 participants
Enrollment target

Study Summary

The purpose of this research is to investigate the effects of a PB no- added-fat and the AHA and MED in obese (BMI \>95%) children ages 9-18 with hypercholesterolemia (\>169 mg/dl) and a parent or guardian. Eligible patients will be identified by utilizing the Pediatric Obesity Registry. When possible, in-person discussions or phone calls with their primary or tertiary care physicians will introduce eligible patients and their parents to the study. All eligible patients and parents will receive letters describing the study and requesting their participation. Subjects can choose not to participate in the study, and their health care will not be affected in any way. Subjects not participating will be asked if they are willing to answer a brief questionnaire about why they chose not to participate. The proposed study will be carried out for a total of 52 weeks. The investigators expect to recruit a total of 180 participants (30 children and 30 parents/guardians in each of the three groups). Each child and parent/guardian pair will be randomly assigned to either PB no-added-fat, AHA or MED.

Primary Outcome

Change in lipid panel, myeloperoxidase, hs C-reactive protein, insulin, glucose, HgbA1C, ALT, AST levels at 4 weeks and 52 weeks after baseline

Interventions

  • OTHER Mediterranean Diet
  • OTHER Plant-Based Diet
  • OTHER American Heart Association Diet

Trial Details

FieldValue
Enrollment Target 180 participants
Start Date 2016-06
Est. Completion 2021-10-25
Phase NA
The Cleveland Clinic

688 total trials

What the finished NCT02857543 record still lists

NCT02857543 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower).

The record links to 0 conditions, and to 3 interventions - of which Mediterranean Diet is the first listed.

NCT02857543 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02857543 about?

NCT02857543 is a clinical study titled "Plant-Based, American Heart Assoc. or Mediterranean Diets In 9-18 yo With BMI >95%, Cholesterol >169 and Their Parents". The purpose of this research is to investigate the effects of a PB no- added-fat and the AHA and MED in obese (BMI \>95%) children ages 9-18 with hypercholesterolemia (\>169 mg/dl) and a parent or guardian. Eligible patients will be identified by utilizing the Pediatric Obesity Registry. When possib...

What is the current status of trial NCT02857543?

This trial is currently completed. It is a NA study. The enrollment target is 180 participants. The study started on 2016-06. Estimated completion is 2021-10-25.

What interventions are being tested in trial NCT02857543?

The interventions under investigation include: Mediterranean Diet (OTHER), Plant-Based Diet (OTHER), American Heart Association Diet (OTHER).

Who is sponsoring clinical trial NCT02857543?

This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02857543's enrollment target sits among peer trials

180 586th of 2000 higher than 1,397 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02857543, the US trial registry maintained by the National Library of Medicine. NCT02857543 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.