Purdue University
West Lafayette, Indiana, 47907, United States
NCT Number: NCT04820829
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.
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Notify Me30 year–69 year
All sexes
Interventional
Not applicable
West Lafayette, Indiana, 47907, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants in this group will consume nine 3-oz-eq servings of RM per week and 2-oz-eq servings of NSS per week.
Participants in this group will consume five 3-oz-eq servings of RM per week and 5-oz-eq servings of NSS per week.
Participants in this group will consume one 3-oz-eq serving of RM per week and 8-oz-eq servings of NSS per week.
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: 5 weeks
Change in diastolic and systolic blood pressure
Time frame: Measures will be taken twice per week throughout the entire enrollment period (15 weeks)
Measures of weight in kilograms (kg)
Purdue University
Other
Effects of Proportioning Meat and Plant-based Protein-rich Foods Within the U.S. Healthy Eating Pattern on Cardiovascular Disease Risk Factors (S58)
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