Effects of Proportioning Meat and Plant-based Protein-rich Foods on Cardiovascular Disease Risk Factors (S58)

NCT ID: NCT04820829

Last Updated: 2024-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2023-11-20

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 Eating Pattern (HEP) on cardiovascular disease risk factors in adults at high risk of developing a heart-related disease.

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 recruited. Participants will consume a HEP - all foods provided - during 5-week controlled feeding periods. The three HEP interventions will be: high RM, low NSS; moderate RM, moderate NSS; and low RM, high NSS. Each participant will complete two of the three controlled feeding periods, separated by four weeks when participants will consume their usual unrestricted diet (washout). The HEP consumed during the controlled feeding periods will be the same except for the amounts of RM (1, 5, or 9, 3-oz servings/wk) and NSS (high, moderate, and low, with amounts adjusted to isocalorically offset changes in RM energy intakes). Poultry, egg, and legume intakes will be the same among the three HEP. The investigators will measure clinically important cardiovascular disease risk factors before (usual unrestricted diet) and during the last week of each HEP intervention. The cardiovascular disease risk factors will include, but are not limited to, comprehensive lipid and lipoprotein profile (changes in low-density lipoprotein cholesterol, LDL-C; primary outcome), lipoprotein fractionation and particle numbers, and blood pressure. The investigators will compare improvements in heart disease risk factors and consumer satisfaction among the three HEP.

Conditions

Healthy Diet; Cardiovascular Risk Factor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

High RM, low NSS

Participants in this group will consume nine 3-oz-eq servings of RM per week and 2-oz-eq servings of NSS per week.

Group Type: ACTIVE_COMPARATOR

High RM, low NSS

Intervention Type: OTHER

Participants in this group will consume nine 3-oz-eq servings of RM per week and 2-oz-eq servings of NSS per week.

Moderate RM, moderate NSS

Participants in this group will consume five 3-oz-eq servings of RM per week and 5-oz-eq servings of NSS per week.

Group Type: ACTIVE_COMPARATOR

Moderate RM, Moderate NSS

Intervention Type: OTHER

Participants in this group will consume five 3-oz-eq servings of RM per week and 5-oz-eq servings of NSS per week.

Low RM, high NSS

Participants in this group will consume one 3-oz-eq serving of RM per week and 8-oz-eq servings of NSS per week.

Group Type: ACTIVE_COMPARATOR

Low RM, High NSS

Intervention Type: OTHER

Participants in this group will consume one 3-oz-eq serving of RM per week and 8-oz-eq servings of NSS per week.

Interventions

High RM, low NSS

Participants in this group will consume nine 3-oz-eq servings of RM per week and 2-oz-eq servings of NSS per week.

Intervention Type: OTHER

Moderate RM, Moderate NSS

Participants in this group will consume five 3-oz-eq servings of RM per week and 5-oz-eq servings of NSS per week.

Intervention Type: OTHER

Low RM, High NSS

Participants in this group will consume one 3-oz-eq serving of RM per week and 8-oz-eq servings of NSS per week.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Purdue University

OTHER

Sponsor Role: lead

Responsible Party

Wayne Campbell

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wayne Campbell, PhD

Role: PRINCIPAL_INVESTIGATOR

Purdue University

Locations

Purdue University

West Lafayette, Indiana, United States

Countries

United States

Other Identifiers

IRB-2020-587

Identifier Type: -

Identifier Source: org_study_id