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Effects of Replacing Starchy Vegetables and Refined Grains With Beef on Cardio-metabolic Disease Risk Factors (S53)

  • Clinicaltrials.gov identifier

    NCT03925142

  • Recruitment Status

    Recruiting

  • First Posted

    April 24, 2019

  • Last update posted

    July 16, 2020

Study Description

Brief summary:

The purpose of this study is to assess the effects of replacing starchy vegetables and refined grains with beef in a vegetarian diet on cardio-metabolic disease risk factors in adults in a cross-over, randomized controlled feeding trial.

  • Condition or Disease:Diet Modification
  • Intervention/Treatment: Other: Controlled healthy vegetarian diet
    Other: Controlled beef diet
  • Phase: N/A

Detailed Description

The purpose of this study is to assess the effects of replacing starchy vegetables and refined grains with beef in a vegetarian diet on cardio-metabolic disease risk factors in adults in a cross-over, randomized controlled feeding trial. The hypothesis is that isocalorically replacing predominantly starchy vegetables and refined grains with 6 oz. of beef/day will enhance improvements in cardiometabolic disease risk factors, particularly atherosclerotic-promoting lipids and lipoproteins. It is also hypothesized that participant satisfaction and acceptance of a healthy eating pattern with 6 oz. of beef per day will be higher compared to without beef.

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 60 participants
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Intervention Model Description: This is a 16-week randomized, cross-over, controlled, single-blind study. During weeks 1 and 11, participant's usual, unrestricted dietary intakes will be assessed. At week 2, they will be randomized and assigned to consume either the controlled lacto-ovo vegetarian diet or beef diet for the first 5-week dietary intervention during weeks 2-6. They will consume the other diet during weeks 12-16. Two fasting-state serum samples and one stool samples will be collected during study weeks 1,6,11, and 16.
  • Masking: Single (Outcomes Assessor)
  • Primary Purpose: Other
  • Official Title: Effects of Replacing Starchy Vegetables and Refined Grains With Beef in a Vegetarian Diet on Cardio-metabolic Disease Risk Factors
  • Actual Study Start Date: June 2019
  • Estimated Primary Completion Date: February 2021
  • Estimated Study Completion Date: February 2021

Arms and interventions

Arm Intervention/treatment
Active Comparator: Controlled healthy vegetarian diet
Subjects will be randomized and assigned to consume the controlled Healthy Vegetarian Eeating Pattern for 5 weeks.
Other: Controlled healthy vegetarian diet
The controlled healthy vegetarian diet will follow the Dietary Guidelines for American's recommendations. All foods and beverages will be provided during intervention to achieve the desired eating pattern.
Experimental: Controlled beef diet
Subjects will be randomized and assigned to consume the beef diet for 5 weeks, which will substitute predominantly starchy vegetables and refined grains with 6 oz. of lean unprocessed beef/day.
Other: Controlled beef diet
The controlled beef diet will incorporate various cuts of lean unprocessed red meat into the healthy vegetarian eating pattern, as approved by the American Heart Association's Food Certification Program. The beef diet will isocalorically replace starchy vegetables and/or refined grains with 6 oz. of beef/day for five weeks.

Outcome Measures

  • Primary Outcome Measures: 1. Concentrations of serum lipids, lipoproteins, and total apolipoprotein B [ Time Frame: 1.5 years ]
    The hypothesis is that substituting starchy vegetables and refined grain with lean unprocessed beef in a plant based eating pattern will result in greater reduction in the concentrations of low-density lipoprotein-cholesterol, total cholesterol, triglycerides, and total apolipoprotein B, but greater increase in concentration of high-density lipoprotein-cholesterol.
  • Secondary Outcome Measures: 1. Level of fasting blood pressure [ Time Frame: 1.5 years ]
    The hypothesis is that substituting starchy vegetables and refined grain with lean unprocessed beef in a plantbased eating pattern will result in greater reductions in fasting blood pressure.
  • 2. Level of fasting serum insulin [ Time Frame: 1.5 years ]
    The hypothesis is that substituting starchy vegetables and refined grain with lean unprocessed beef in a plantbased eating pattern will result in greater reductions in fasting serum insulin.
  • 3. Concentration of fasting serum glucose [ Time Frame: 1.5 years ]
    The hypothesis is that substituting starchy vegetables and refined grain with lean unprocessed beef in a plantbased eating pattern will result in greater reductions in fasting serum glucose.
  • 4. Size of lipoprotein particle [ Time Frame: 1.5 years ]
    The hypothesis is that substituting starchy vegetables and refined grain with lean unprocessed beef in a plantbased eating pattern will result in greater reductions in low-density lipoprotein particle size.
  • Other Outcome Measures: 1. Questionnaire score of consumer satisfaction of a plant-based eating pattern [ Time Frame: 1.5 years ]
    The hypothesis is that substituting starchy vegetables and refined grain with lean unprocessed beef in a plant-based eating pattern will result in a higher score of consumer satisfaction using the Dietary Satisfaction Questionnaire designed by study investigators. The Dietary Satisfaction Questionnaire is a six-point Likert scale ranging from "strongly disagree" to "strongly agree". The questionnaire includes 23 questions on overall satisfaction of different aspects of the intervention diets, such as fullness after meals, enjoyment of study foods, and impact of study foods on personal well-being. The Likert scale will be matched to numerical values for scoring (0=strongly disagree, 1=disagree, 2=slightly disagree, 3=slightly agree, 4=agree, 5=strongly agree). Total score ranges from 0 to 115 and higher score represents higher dietary satisfaction.

Eligibility Criteria

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

Criteria

Inclusion Criteria:

- Male or female

- 30-69 years old

- BMI 25-37 kg/m2

- Total cholesterol <260 mg/dL - Low-density lipoprotein cholesterol <190 mg/dL - Glucose <110 mg/dL - Systolic/diastolic blood pressure < 140/90 - 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 - Not drinking more than 2 alcoholic drinks per day - Non-diabetic - Not lactose-intolerant - Not acutely ill - Non-pregnant and not lactating. - Participants must be willing and able to consume the prescribed diets (lacto-ovo vegetarian and omnivorous). Exclusion Criteria: - 69 years old

- BMI 37 kg/m2

- Fasting serum total cholesterol > 260 mg/dL

- Low-density lipoprotein cholesterol >189 mg/dL

- Glucose >110 mg/dL

- Systolic/diastolic blood pressure > 140/90

- Body weight stable for <3 months prior (±3 kg) - Stable physical activity regimen < 3 months prior - Medication use unstable for 6 months prior and using medications - Smoking - Drinking more than 2 alcoholic drinks per day - Diabetic - Have renal failure - Have liver failure - Have cardiovascular events (myocardial infarction or stroke) during the 6 months prior to the study - Pregnant or lactating

Contacts and Locations

Contacts

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

Contact: Yu Wang, BS 765-494-7922 wang3651@purdue.edu

Locations

United States, Indiana
Purdue University
West Lafayette

Sponsors and Collaborators

Purdue University

Investigators

Principal Investigator: Wayne W Campbell, PhD Purdue University

More Information

  • Responsible Party: Purdue University
  • ClinicalTrials.gov Identifier: NCT03925142 History of Changes
  • Other Study ID Numbers: 1809021091
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: July 16, 2020
  • Last Verified: July 2020
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Purdue University: beef cardio-metabolic disease
  • Additional relevant MeSH terms: Metabolic Diseases