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

Not Applicable

Completed

• Conditions: Cardiovascular Risk Factor; Healthy Diet
• Interventions: Other: Moderate RM, Moderate NSS; Other: Low RM, High NSS; Other: High RM, low NSS

• Registration Number: NCT04820829
• Lead Sponsor: Purdue University

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.

Study Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2021-03-24
• Study First Submitted QC: 2021-03-26
• Study First Posted: 2021-03-29
• Primary Completion: 2023-11-20
• Study Completion: 2023-11-20
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-12
• Last Update Posted: 2024-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Moderate RM, moderate NSS	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.
Low RM, high NSS	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.
High RM, low NSS	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.

Primary Outcome Measures

Name	Time	Method
Risk factors for cardiovascular disease	5 weeks	Lipoprotein Particle Plus (LPP+) Panel. This comprehensive lipid panel will provide us with lipoprotein fractionation and particle number (VLDL, non-HDL, remnant lipoprotein, small/dense LDL III and IV, total measured HDL and LDL, and large buoyant HDL 2b), homocysteine, insulin, apolipoprotein A1, total apolipoprotein B, lipoprotein a, high sensitivity C-reactive protein, and a traditional lipid panel (total cholesterol, HDL cholesterol, calculated LDL cholesterol, triglycerides)

Secondary Outcome Measures

Name	Time	Method
Body weight	Measures will be taken twice per week throughout the entire enrollment period (15 weeks)	Measures of weight in kilograms (kg)
Change in consumer perception and satisfaction of the HEPs	5 weeks	Consumer satisfaction and acceptance questionnaire. At the end of each dietary intervention, we will assess participants' satisfaction and acceptance of each HEP via an exit interview-style questionnaire
Risk factors for cardiometabolic disease	5 weeks	comprehensive metabolic panel which will include glucose, blood urea nitrogen (as a crude marker of protein intake), and markers of kidney and liver functions. Additionally, predictions of long-term cardiovascular disease risk and vascular age will be calculated using the Framingham Heart Study 10-year cardiovascular disease risk lipid equation.
Risk factors for cardiovascular disease	5 weeks	Change in diastolic and systolic blood pressure

Trial Locations

Locations (1)

Purdue University; 🇺🇸 West Lafayette, Indiana, United States