Clinical trial NCT04820829: Effects of Proportioning Meat and Plant-based Protein-rich Foods on Cardiovascular Disease Risk Factors (S58)
Official title: Effects of Proportioning Meat and Plant-based Protein-rich Foods Within the U.S. Healthy Eating Pattern on Cardiovascular Disease Risk Factors (S58)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Diet
Cardiovascular Risk Factor
Keywords: Healthy eating pattern
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 44
Sex: ALL
Minimum age (years): 30
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The Investigator will use a randomized, cross-over (balanced incomplete block) experimental design, with separate randomizations for males and females. All participants will consume a U.S. HEP - all foods provided - during 5-week controlled feeding periods. Each participant will complete two of the three controlled feeding periods, separated by four weeks when they will consume their usual unrestricted diet (washout). The three HEP interventions will be: high RM, low NSS; moderate RM, moderate NSS; and low RM, high NSS. Measurements will be made before (usual unrestricted diet) and during the last week of each HEP intervention.
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Risk factors for cardiovascular disease
timeFrame: 5 weeks
Secondary outcomes:
measure: Change in consumer perception and satisfaction of the HEPs
timeFrame: 5 weeks
measure: Risk factors for cardiometabolic disease
timeFrame: 5 weeks
measure: Risk factors for cardiovascular disease
timeFrame: 5 weeks
measure: Body weight
timeFrame: Measures will be taken twice per week throughout the entire enrollment period (15 weeks)
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
affiliation: Purdue University
name: Wayne Campbell, PhD
role: PRINCIPAL_INVESTIGATOR
References: