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

Purdue University

Status: Completed

Conditions: Healthy Diet; Cardiovascular Risk Factor

Treatments: Other: High RM, low NSS; Other: Moderate RM, Moderate NSS; Other: Low RM, High NSS

Study type: Interventional

Funder types: Other

Identifiers

NCT04820829

IRB-2020-587

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 30 to 69 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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44 participants in 3 patient groups

High RM, low NSS

Active Comparator group

Description:

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

Treatment:

Other: High RM, low NSS

Moderate RM, moderate NSS

Active Comparator group

Description:

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

Treatment:

Other: Moderate RM, Moderate NSS

Low RM, high NSS

Active Comparator group

Description:

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

Treatment:

Other: Low RM, High NSS