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

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ClinicalTrials.gov Identifier: NCT04820829
Recruitment Status : Recruiting
First Posted : March 29, 2021
Last Update Posted : March 29, 2021
Sponsor:
Information provided by (Responsible Party):
Wayne Campbell, Purdue University

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.

Condition or disease Intervention/treatment Phase
Healthy Diet Cardiovascular Risk Factor Other: High RM, low NSS Other: Moderate RM, Moderate NSS Other: Low RM, High NSS Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: Single (Investigator)
Primary Purpose: Screening
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)
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : September 1, 2022

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.
Other: 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.

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.
Other: 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.

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.
Other: 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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. Risk factors for cardiovascular disease [ Time Frame: 5 weeks ]
    Change in diastolic and systolic blood pressure

  4. Body weight [ Time Frame: Measures will be taken twice per week throughout the entire enrollment period (15 weeks) ]
    Measures of weight in kilograms (kg)



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Ages Eligible for Study:   30 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04820829


Contacts
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Contact: Jan Green 765-496-6342 jkgreen@purdue.edu

Locations
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United States, Indiana
Purdue University Recruiting
West Lafayette, Indiana, United States, 47907
Contact: Jan Green    765-496-6342    jkgreen@purdue.edu   
Contact: Wayne Campbell, PhD    765-494-8236    campbeww@purdue.edu   
Sponsors and Collaborators
Purdue University
Investigators
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Principal Investigator: Wayne Campbell, PhD Purdue University
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Responsible Party: Wayne Campbell, Principal Investigator, Purdue University
ClinicalTrials.gov Identifier: NCT04820829    
Other Study ID Numbers: IRB-2020-587
First Posted: March 29, 2021    Key Record Dates
Last Update Posted: March 29, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wayne Campbell, Purdue University:
Healthy eating pattern
Additional relevant MeSH terms:
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Cardiovascular Diseases