Status:
COMPLETED
Effects of Proportioning Meat and Plant-based Protein-rich Foods on Cardiovascular Disease Risk Factors (S58)
Lead Sponsor:
Purdue University
Conditions:
Healthy Diet
Cardiovascular Risk Factor
Eligibility:
All Genders
30-69 years
Phase:
NA
Brief Summary
This project will assess the effects of consuming different proportions of red meat (RM) and plant-based, protein-rich foods (nuts, seeds, and soy products - NSS) incorporated into a U.S. Healthy Eati...
Detailed Description
Using a randomized, cross-over (balanced incomplete block) experimental design, Forty-eight middle-aged adults who are overweight and have high blood total cholesterol and LDL-C concentrations will be...
Eligibility Criteria
Inclusion
- Male or female;
- Age 30-69 y;
- BMI: 25.0-37 kg/m2;
- Have hypercholesterolemia (total and LDL cholesterol 200-259 and 130-189 mg/dL, respectively),
- Systolic/diastolic blood pressure \<140/90 mm Hg;
- Triglycerides \<399 mg/dL, fasting glucose \<109 mg/dL
- Body weight stable for 3 months prior (±3 kg);
- Stable physical activity regimen 3 months prior;
- Medication use stable for 6 months prior;
- Non-smoking;
- Non-diabetic;
- Not acutely ill;
- Females not pregnant or lactating;
- Participants must be willing and able to consume the prescribed diets and travel to testing facilities.
Exclusion
- BMI \<25 or \>37
- Total cholesterol \>259 mg/dL, low-density lipoprotein cholesterol \>189 mg/dL,
- Triglycerides \>400 mg/dL, fasting glucose \>110 mg/dL
- Body weight changes in previous 3 months (±3 kg)
- Changes in physical activity regimen in the previous 3 months
- Medication changes in the previous 6 months
- Smoking
- Diabetic
- Acute illness
- Pregnant or lactating
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2023
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04820829
Start Date
March 1 2021
End Date
November 20 2023
Last Update
February 14 2024
Active Locations (1)
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1
Purdue University
West Lafayette, Indiana, United States, 47907