Clinical trial NCT03925142: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diet Modification
Keywords: beef
cardio-metabolic disease
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2019-04-24
Enrollment: 43
Sex: ALL
Minimum age (years): 30
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: OTHER

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.

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.

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

Primary outcomes:
measure: Concentrations of serum lipids, lipoproteins, and total apolipoprotein B
timeFrame: 1.5 years
Secondary outcomes:
measure: Level of fasting blood pressure
timeFrame: 1.5 years
measure: Level of fasting serum insulin
timeFrame: 1.5 years
measure: Concentration of fasting serum glucose
timeFrame: 1.5 years
measure: Size of lipoprotein particle
timeFrame: 1.5 years
Other outcomes:
measure: Questionnaire score of consumer satisfaction of a plant-based eating pattern
timeFrame: 1.5 years
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
affiliation: Purdue University
name: Wayne W Campbell, PhD
role: PRINCIPAL_INVESTIGATOR
References: