NCT04820829

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

Effects of Proportioning Meat and Plant-based Protein-rich Foods Within the U.S. Healthy Eating Pattern on Cardiovascular Disease Risk Factors (S58)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Purdue University · Academic / Other
• Sex: All
• Age: 30 Years – 69 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
OTHER	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.
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.
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.

Timeline

• Start date: 2021-03-01
• Primary completion: 2023-11-20
• Completion: 2023-11-20
• First posted: 2021-03-29
• Last updated: 2024-02-14

Locations

1 site across 1 country: United States