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

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

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.

Study Overview

• Status: Completed
• Conditions: Diet Modification
• Intervention / Treatment: Other: Controlled healthy vegetarian diet; Other: Controlled beef diet

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 Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • West Lafayette, Indiana, United States, 47907
      • Purdue University

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentrations of serum lipids, lipoproteins, and total apolipoprotein B	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.	1.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of fasting blood pressure	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.	1.5 years
Level of fasting serum insulin	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.	1.5 years
Concentration of fasting serum glucose	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.	1.5 years
Size of lipoprotein particle	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.	1.5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire score of consumer satisfaction of a plant-based eating pattern	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.	1.5 years

Collaborators and Investigators

• Sponsor: Purdue University

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2019
• Primary Completion (Actual): October 28, 2021
• Study Completion (Actual): October 28, 2021

Study Registration Dates

• First Submitted: April 9, 2019
• First Submitted That Met QC Criteria: April 22, 2019
• First Posted (Actual): April 24, 2019

Study Record Updates

• Last Update Posted (Actual): December 8, 2021
• Last Update Submitted That Met QC Criteria: December 7, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: beef; cardio-metabolic disease
• Additional Relevant MeSH Terms: Metabolic Diseases
• Other Study ID Numbers: 1809021091

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No