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

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ClinicalTrials.gov Identifier: NCT03925142
Recruitment Status : Recruiting
First Posted : April 24, 2019
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
Wayne Campbell, Purdue University

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.

Condition or disease Intervention/treatment Phase
Diet Modification Other: Controlled healthy vegetarian diet Other: Controlled beef diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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.
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 : June 4, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Concentrations of serum lipids, lipoproteins, and total apolipoprotein B [ Time Frame: 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 :
  1. Level of fasting blood pressure [ Time Frame: 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.

  2. Level of fasting serum insulin [ Time Frame: 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.

  3. Concentration of fasting serum glucose [ Time Frame: 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.

  4. Size of lipoprotein particle [ Time Frame: 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:
  1. Questionnaire score of consumer satisfaction of a plant-based eating pattern [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03925142


Contacts
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Contact: Jan Green 765-496-6342 jkgreen@purdue.edu
Contact: Yu Wang, BS 765-494-7922 wang3651@purdue.edu

Locations
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United States, Indiana
Purdue University Recruiting
West Lafayette, Indiana, United States, 47907
Contact: Erica Hill, BS    765-496-6342    hill155@purdue.edu   
Contact: Yu Wang, BS    765-496-6342    wang3651@purdue.edu   
Sponsors and Collaborators
Purdue University
Investigators
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Principal Investigator: Wayne W Campbell, PhD Purdue University

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Responsible Party: Wayne Campbell, Principal Investigator, Purdue University
ClinicalTrials.gov Identifier: NCT03925142     History of Changes
Other Study ID Numbers: 1809021091
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wayne Campbell, Purdue University:
beef
cardio-metabolic disease
Additional relevant MeSH terms:
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Metabolic Diseases