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Diets for Heart Disease

N/A
Waitlist Available
Led By Thomas Campbell, MD
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >50
Diagnosis of any of the following cardiovascular risk factors: hypertension (Diagnosis present in chart or use of antihypertensive medications); hyperlipidemia/dyslipidemia (non-HDL cholesterol ≥ 130 within the past year or current use of antihyperlipidemic medication); prediabetes (HbA1c ≥ 5.7% and < 6.5% in the past year); diabetes (HbA1c ≥ 6.5% in the past year); obesity (body mass index ≥ 30)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights

Study Summary

This trialtests two diets and their short-term effects on markers of heart health. Cholesterol, blood pressure, inflammation, and more will be measured.

Who is the study for?
This trial is for individuals over 50 who can speak and read English, with cardiovascular risk factors like high blood pressure, high cholesterol, prediabetes or diabetes, and obesity. They must be willing to follow the study's diet plan and attend meetings. People with recent major surgery, kidney or liver disease, high alcohol use, certain food allergies/intolerances, recent heart attack or those already on a specialized diet are excluded.Check my eligibility
What is being tested?
The trial is testing how a low-carbohydrate diet versus a whole-food plant-based diet affects vascular health in the short term. Participants will switch between diets during the study period while researchers measure their cholesterol levels, blood pressure, inflammation markers as well as endothelial progenitor cells and trimethylamine N-oxide.See study design
What are the potential side effects?
While not explicitly stated in this summary information provided about side effects of dietary interventions may include digestive changes such as constipation or bloating (low-carb) or increased gas (plant-based), potential nutrient deficiencies if not properly managed and possible initial weight fluctuations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 50 years old.
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I have been diagnosed with or am being treated for high blood pressure, high cholesterol, prediabetes, diabetes, or obesity.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Endothelial Progenitor Cells
HDL function
trimethylamine N-oxide
Secondary outcome measures
Blood Glucose
Blood Pressure
Change in nutritional intake
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Whole-Food, Plant-Based StartExperimental Treatment1 Intervention
This group starts with the whole-food, plant-based diet, then gets the low-carbohydrate diet after the washout period.
Group II: Low-Carbohydrate StartExperimental Treatment1 Intervention
This group starts with the low-carbohydrate diet, then gets the whole-food, plant-based diet after the washout period.

Find a Location

Who is running the clinical trial?

University of RochesterLead Sponsor
833 Previous Clinical Trials
518,099 Total Patients Enrolled
Thomas Campbell, MDPrincipal InvestigatorUniversity of Rochester

Media Library

Low-Carbohydrate Diet Clinical Trial Eligibility Overview. Trial Name: NCT05414851 — N/A
High Cholesterol Research Study Groups: Whole-Food, Plant-Based Start, Low-Carbohydrate Start
High Cholesterol Clinical Trial 2023: Low-Carbohydrate Diet Highlights & Side Effects. Trial Name: NCT05414851 — N/A
Low-Carbohydrate Diet 2023 Treatment Timeline for Medical Study. Trial Name: NCT05414851 — N/A

Frequently Asked Questions

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

Are recruitment efforts ongoing for this experiment?

"Affirmative. Clinicaltrials.gov's records indicate that enrollment for this study is ongoing, having been first advertised on 20th December 2022 and most recently updated on 22nd December 2022. 40 participants are being recruited from a single facility for the trial."

Answered by AI

What is the current size of the cohort participating in this clinical research?

"That is accurate. According to information accessible through clinicaltrials.gov, this medical experiment was first published on December 20th 2022 and has been actively recruiting since then. 40 participants are required from 1 centre in order for the study to be successful."

Answered by AI
~5 spots leftby Jun 2024