- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04820829
Effects of Proportioning Meat and Plant-based Protein-rich Foods on Cardiovascular Disease Risk Factors (S58)
February 12, 2024 updated by: Wayne Campbell, Purdue University
Effects of Proportioning Meat and Plant-based Protein-rich Foods Within the U.S. Healthy Eating Pattern on Cardiovascular Disease Risk Factors (S58)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jan Green
- Phone Number: 765-496-6342
- Email: jkgreen@purdue.edu
Study Locations
-
-
Indiana
-
West Lafayette, Indiana, United States, 47907
- Purdue University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 69 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
Participants in this group will consume nine 3-oz-eq servings of RM per week and 2-oz-eq servings of NSS per week.
|
Active Comparator: 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.
|
Participants in this group will consume five 3-oz-eq servings of RM per week and 5-oz-eq servings of NSS per week.
|
Active Comparator: 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.
|
Participants in this group will consume one 3-oz-eq serving of RM per week and 8-oz-eq servings of NSS per week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
5 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in consumer perception and satisfaction of the HEPs
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
|
5 weeks
|
Risk factors for cardiometabolic disease
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.
|
5 weeks
|
Risk factors for cardiovascular disease
Time Frame: 5 weeks
|
Change in diastolic and systolic blood pressure
|
5 weeks
|
Body weight
Time Frame: Measures will be taken twice per week throughout the entire enrollment period (15 weeks)
|
Measures of weight in kilograms (kg)
|
Measures will be taken twice per week throughout the entire enrollment period (15 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Wayne Campbell, PhD, Purdue University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2021
Primary Completion (Actual)
November 20, 2023
Study Completion (Actual)
November 20, 2023
Study Registration Dates
First Submitted
March 24, 2021
First Submitted That Met QC Criteria
March 26, 2021
First Posted (Actual)
March 29, 2021
Study Record Updates
Last Update Posted (Actual)
February 14, 2024
Last Update Submitted That Met QC Criteria
February 12, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-2020-587
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardiovascular Risk Factor
-
University of Southern DenmarkRegion of Southern Denmark; Odense Patient Data Explorative Network; ENIGMA Solutions... and other collaboratorsActive, not recruitingCardiovascular Risk Factor | Risk CommunicationDenmark
-
University of Split, School of MedicineCompletedCardiovascular Risk Factor | Lifestyle Risk ReductionCroatia
-
University Hospital, BrestRecruiting
-
University Hospitals Cleveland Medical CenterRecruitingCardiovascular Risk FactorUnited States
-
Northwestern UniversityNorthShore University HealthSystem; Case Western Reserve University; Shirley... and other collaboratorsCompleted
-
University of ArizonaTerminatedCardiovascular Risk FactorUnited States
-
Penn State UniversityCompletedCardiovascular Risk FactorUnited States
-
Clinique BizetCompleted
-
University Hospital, BrestCompleted
-
University of DelawareCompleted
Clinical Trials on High RM, low NSS
-
Mansoura UniversityCompleted
-
Mansoura UniversityEnrolling by invitationAnesthesia Induced AtelectasisEgypt
-
University of ChicagoCompleted
-
Universidad Católica San Antonio de MurciaRecruiting
-
University of AberdeenUniversity of DundeeUnknown
-
Purdue UniversityGrain Food FoundationRecruitingHigh Whole Grain and Low Sugar | Medium Whole Grain and Low Sugar | Low Whole Grain and Low Sugar | Low Whole Grain and High SugarUnited States
-
Temple UniversityInternational Life Sciences InstituteCompleted
-
Cancer Institute and Hospital, Chinese Academy...UnknownBrain Death | ComaChina
-
Arkansas Children's Hospital Research InstituteActive, not recruiting
-
Maastricht University Medical CenterCompleted