RECRUITING

The Effects of Healthy Diets With Plant Oils on Heart and Metabolic Health

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will examine the effect of a healthy diet containing cottonseed oil compared to healthy diets containing other commonly consumed plant oils on biomarkers of heart and metabolic health after 4 weeks.

Official Title

The Effects of Healthy Diets With Plant Oils on Heart and Metabolic Health: A Randomized, Crossover, Controlled-feeding Study

Quick Facts

Study Start:2024-09-09

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06216678

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* LDL-C ≥100 mg/dL and ≤190 mg/dL * BMI of 25-40 kg/m2 * Blood pressure \<140/90 mmHg * Fasting blood glucose \<126 mg/dL * Fasting triglycerides \<350 mg/dL * ≤10% change in body weight for 6 months prior to enrollment	* Type 1 or type 2 diabetes or fasting blood glucose ≥126 mg/dL * Prescription of anti-hypertensive, lipid lowering or glucose lowering drugs * Intake of supplements that affect the outcomes of interest and unwilling to cease during the study period * Diagnosed liver, kidney, or autoimmune disease * Prior cardiovascular event (e.g., stroke, heart attack) * Current pregnancy or intention of pregnancy within the next 6 months * Lactation within prior 6 months * Follows a vegetarian or vegan diet * Food allergies/intolerance/sensitives/dislikes of foods included in the study menu * Antibiotic use within the prior 1 month * Oral steroid use within the prior 1 month * Use of tobacco or nicotine containing products with in the past 6 months * Cancer any site within the past 10 years (eligible if ≥10 years without recurrence) or non-melanoma skin cancer with in the past 5 years (eligible if ≥5 years without recurrence) * Participation in another clinical trial within 30 days of baseline * Currently following a restricted or weight loss diet * Prior bariatric surgery * Intake of \>14 alcoholic drinks/week and/or lack of willingness to consume a maximum of two standard drinks per week while enrolled in the study and/or not willing to avoid alcohol consumption for 48 hour prior to test visits

Inclusion Criteria

Exclusion Criteria

* LDL-C ≥100 mg/dL and ≤190 mg/dL
* BMI of 25-40 kg/m2
* Blood pressure \<140/90 mmHg
* Fasting blood glucose \<126 mg/dL
* Fasting triglycerides \<350 mg/dL
* ≤10% change in body weight for 6 months prior to enrollment

* Type 1 or type 2 diabetes or fasting blood glucose ≥126 mg/dL
* Prescription of anti-hypertensive, lipid lowering or glucose lowering drugs
* Intake of supplements that affect the outcomes of interest and unwilling to cease during the study period
* Diagnosed liver, kidney, or autoimmune disease
* Prior cardiovascular event (e.g., stroke, heart attack)
* Current pregnancy or intention of pregnancy within the next 6 months
* Lactation within prior 6 months
* Follows a vegetarian or vegan diet
* Food allergies/intolerance/sensitives/dislikes of foods included in the study menu
* Antibiotic use within the prior 1 month
* Oral steroid use within the prior 1 month
* Use of tobacco or nicotine containing products with in the past 6 months
* Cancer any site within the past 10 years (eligible if ≥10 years without recurrence) or non-melanoma skin cancer with in the past 5 years (eligible if ≥5 years without recurrence)
* Participation in another clinical trial within 30 days of baseline
* Currently following a restricted or weight loss diet
* Prior bariatric surgery
* Intake of \>14 alcoholic drinks/week and/or lack of willingness to consume a maximum of two standard drinks per week while enrolled in the study and/or not willing to avoid alcohol consumption for 48 hour prior to test visits

Contacts and Locations

Study Contact

Kristina Petersen, PhD

CONTACT

814-865-7206

kup63@psu.edu

Stacey Meily

CONTACT

814-863-8622

sas117@psu.edu

Study Locations (Sites)

The Pennylvania State University

University Park, Pennsylvania, 16802

United States

Collaborators and Investigators

Sponsor: Penn State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-09

Study Completion Date2025-12

Study Record Updates

Study Start Date2024-09-09

Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

Cardiovascular Diseases