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

NCT ID: NCT03925142

Last Updated: 2021-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-04

Study Completion Date

2021-10-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diet Modification

Keywords

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beef cardio-metabolic disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Controlled healthy vegetarian diet

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

Group Type ACTIVE_COMPARATOR

Controlled healthy vegetarian diet

Intervention Type 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

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.

Group Type EXPERIMENTAL

Controlled beef diet

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Purdue University

OTHER

Sponsor Role lead

Responsible Party

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Wayne Campbell

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wayne W Campbell, PhD

Role: PRINCIPAL_INVESTIGATOR

Purdue University

Locations

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Purdue University

West Lafayette, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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1809021091

Identifier Type: -

Identifier Source: org_study_id