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

NCT03925142 | Completed

• 1 other identifier: 1809021091
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diet Modification

Keywords

beef; cardio-metabolic disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Level of fasting blood pressure

  1.5 years

• Level of fasting serum insulin

  1.5 years

• Concentration of fasting serum glucose

  1.5 years

• Size of lipoprotein particle

  1.5 years

Other Outcomes (1)

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

  1.5 years

Study Arms (2)

Controlled healthy vegetarian diet

ACTIVE COMPARATOR

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

Other: Controlled healthy vegetarian diet

Controlled beef diet

EXPERIMENTAL

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

Interventions

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 healthy vegetarian diet

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.

Controlled beef diet

Eligibility Criteria

• Age: 30 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• 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

You may not qualify if:

• \<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

Sponsors & Collaborators

• Purdue University: lead

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

Study Officials

• Wayne W Campbell, PhD

  Purdue University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: April 24, 2019
• Study Start: June 4, 2019
• Primary Completion: October 28, 2021
• Study Completion: October 28, 2021
• Last Updated: December 8, 2021

Record last verified: 2021-12

Locations

US (1)