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

Sponsor

Purdue University (Other)

Overall Status

Completed

CT.gov ID

NCT03925142

Collaborator

(none)

Enrollment

Location

Arms

28.8

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Actual Enrollment :

43 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.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 :

Jun 4, 2019

Actual Primary Completion Date :

Oct 28, 2021

Actual Study Completion Date :

Oct 28, 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.

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

Concentrations of serum lipids, lipoproteins, and total apolipoprotein B [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

Level of fasting blood pressure [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.
Level of fasting serum insulin [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.
Concentration of fasting serum glucose [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.
Size of lipoprotein particle [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

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

Criteria

Ages Eligible for Study:

30 Years to 69 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Purdue University	West Lafayette	Indiana	United States	47907

Sponsors and Collaborators

Purdue University

Investigators

Principal Investigator: Wayne W Campbell, PhD, Purdue University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wayne Campbell, Principal Investigator, Purdue University

ClinicalTrials.gov Identifier:

NCT03925142

Other Study ID Numbers:

1809021091

First Posted:

Apr 24, 2019

Last Update Posted:

Dec 8, 2021

Last Verified:

Dec 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Wayne Campbell, Principal Investigator, Purdue University

beef

cardio-metabolic disease

Additional relevant MeSH terms:

Metabolic Diseases

Study Results

No Results Posted as of Dec 8, 2021