Healthy DietNCT04820829

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

A study testing High RM, low NSS, Moderate RM, Moderate NSS and Low RM, High NSS in people with Healthy Diet and Cardiovascular Risk Factor, run by Purdue University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 30 to 69 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Diet, Cardiovascular Risk Factor
What is being tested?: High RM, low NSS, Moderate RM, Moderate NSS and Low RM, High NSS
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 1 siteUnited States
Study dates: 1 Mar 2021to 20 Nov 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 69 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

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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.

Who cannot join

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

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Smoking
Diabetic
Acute illness
Pregnant or lactating

Trial locations and contacts

1 site in 1 country.

United States1 site

Purdue University
West Lafayette, Indiana, 47907

Other trials in United States

About this study

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)

Read the 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
Being tested: High RM, low NSS, Moderate RM, Moderate NSS, Low RM, High NSS
Keywords: Healthy eating pattern

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04820829
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Other: Low RM, High NSS

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 5 weeks

Secondary outcomes (4)

Change in consumer perception and satisfaction of the HEPs
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
Measured: 5 weeks
Risk factors for cardiometabolic disease
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.
Measured: 5 weeks
Risk factors for cardiovascular disease
Change in diastolic and systolic blood pressure
Measured: 5 weeks
Body weight
Measures of weight in kilograms (kg)
Measured: Measures will be taken twice per week throughout the entire enrollment period (15 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 202120 Nov 2023

First posted29 Mar 2021
Study start1 Mar 2021
Primary completion20 Nov 2023
Study completion20 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy DietStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Randomised
Intervention model: Crossover
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.
Masking: Single blind
Who is masked: Investigator
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04820829
Sponsor's protocol ID: IRB-2020-587
Status last verified: Feb 2024
First submitted: 24 Mar 2021
Last updated: 14 Feb 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT04820829
Acronym / sponsor ID: IRB-2020-587
Conditions: Healthy Diet, Cardiovascular Risk Factor
Keywords: Healthy eating pattern
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Purdue UniversityUniversity, hospital or other
Study start: 1 Mar 2021 (actual)
Primary completion: 20 Nov 2023 (actual)
Study completion: 20 Nov 2023 (actual)
First posted: 29 Mar 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Screening
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (investigator)
Number of arms: 3
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.

Arm	Type	Receives
High RM, low NSS	Active comparator	Other: High RM, low NSSParticipants in this group will consume nine 3-oz-eq servings of RM per week and 2-oz-eq servings of NSS per week.
Moderate RM, moderate NSS	Active comparator	Other: Moderate RM, Moderate NSSParticipants 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	Active comparator	Other: Low RM, High NSSParticipants in this group will consume one 3-oz-eq serving of RM per week and 8-oz-eq servings of NSS per week.

Who may qualify

Ages: 30 to 69 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

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;

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
High RM, low NSSParticipants 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 NSSParticipants 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 NSSParticipants in this group will consume one 3-oz-eq serving of RM per week and 8-oz-eq servings of NSS per week.	Other	Low RM, high NSS

Primary outcome

Risk factors for cardiovascular disease
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)

4 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Wayne Campbell, PhD principal investigator

Purdue University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing High RM, low NSS, Moderate RM, Moderate NSS and Low RM, High NSS in people with Healthy Diet and Cardiovascular Risk Factor, run by Purdue University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Risk factors for cardiovascular disease (time frame: 5 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04820829.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.