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Completed

NCT Number: NCT03925142

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

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.

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Key information

Conditions

Age range

30 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Purdue University

West Lafayette, Indiana, 47907, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • <30 or >69 years old
  • BMI <25.0 or >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

Treatment and study plan

Controlled healthy vegetarian diet

Other

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.

Controlled beef diet

Other

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Purdue University

Other

Registry information

Official study title

Effects of Replacing Starchy Vegetables and Refined Grains With Beef in a Vegetarian Diet on Cardio-metabolic Disease Risk Factors

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 24, 2019
Registry last updated
Dec 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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