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

Primary Purpose

Diet Modification

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Controlled healthy vegetarian diet

Controlled beef diet

About this trial

This is an interventional other trial for Diet Modification focused on measuring beef, cardio-metabolic disease

Eligibility Criteria

30 Years - 69 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Purdue University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Controlled healthy vegetarian diet

Controlled beef diet

Arm Description

Subjects will be randomized and assigned to consume the controlled Healthy Vegetarian Eeating Pattern for 5 weeks.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

Full Information

NCT ID

NCT03925142

First Posted

April 9, 2019

Last Updated

December 7, 2021

Sponsor

Purdue University

1. Study Identification

Unique Protocol Identification Number

NCT03925142

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

June 4, 2019 (Actual)

Primary Completion Date

October 28, 2021 (Actual)

Study Completion Date

October 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Purdue University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diet Modification

Keywords

beef, cardio-metabolic disease

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

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

Outcomes Assessor

Allocation

Randomized

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Controlled healthy vegetarian diet

Arm Type

Active Comparator

Arm Description

Subjects will be randomized and assigned to consume the controlled Healthy Vegetarian Eeating Pattern for 5 weeks.

Arm Title

Controlled beef diet

Arm Type

Experimental

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Controlled healthy vegetarian diet

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Controlled beef diet

Intervention Description

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 Outcome Measure Information:

Title

Concentrations of serum lipids, lipoproteins, and total apolipoprotein B

Description

Time Frame

1.5 years

Secondary Outcome Measure Information:

Title

Level of fasting blood pressure

Description

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.

Time Frame

1.5 years

Title

Level of fasting serum insulin

Description

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.

Time Frame

1.5 years

Title

Concentration of fasting serum glucose

Description

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.

Time Frame

1.5 years

Title

Size of lipoprotein particle

Description

Time Frame

1.5 years

Other Pre-specified Outcome Measures:

Title

Questionnaire score of consumer satisfaction of a plant-based eating pattern

Description

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.

Time Frame

1.5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

69 Years

Accepts Healthy Volunteers

Eligibility 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: <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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wayne W Campbell, PhD

Organizational Affiliation

Purdue University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Purdue University

City

West Lafayette

State/Province

Indiana

ZIP/Postal Code

47907

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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