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Outcome Measures

Primary Outcomes (1)

Risk factors for cardiovascular disease
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)
5 weeks

Secondary Outcomes (4)

Change in consumer perception and satisfaction of the HEPs
5 weeks
Risk factors for cardiometabolic disease
5 weeks
Risk factors for cardiovascular disease
5 weeks
Body weight
Measures will be taken twice per week throughout the entire enrollment period (15 weeks)

Study Arms (3)

High RM, low NSS

ACTIVE COMPARATOR

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: High RM, low NSS

Moderate RM, moderate NSS

ACTIVE COMPARATOR

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: Moderate RM, Moderate NSS

Low RM, high NSS

ACTIVE COMPARATOR

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

Interventions

High RM, low NSSOther

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

High RM, low NSS

Moderate RM, Moderate NSSOther

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

Moderate RM, moderate NSS

Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

SINGLE

Who Masked

INVESTIGATOR

Purpose

SCREENING

Intervention Model

CROSSOVER

Model Details: 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.

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

Principal Investigator

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (3)

High RM, low NSS

Moderate RM, moderate NSS

Low RM, high NSS

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (3)

High RM, low NSS

Moderate RM, moderate NSS

Low RM, high NSS

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations