Status:
WITHDRAWN
Diet Quality, Pecans, and Cardiometabolic Health
Lead Sponsor:
Penn State University
Conditions:
Cardiovascular Diseases
Eligibility:
All Genders
25-70 years
Phase:
PHASE2
Brief Summary
A three-period, randomized, crossover controlled feeding trial will be conducted to examine the effect of including 2 oz./day of pecans, as a snack, in a diet representative of average American intake...
Detailed Description
Participants will be randomized to each diet for 4-weeks with a minimum 2-week break between the diet periods. All caloric foods and beverages will be provided. Outcome assessments will be done at bas...
Eligibility Criteria
Inclusion
- BMI ≥25 and ≤40 kg/m2
- ≥ 1 criterion for metabolic syndrome (i.e. waist circumference ≥ 94 cm men or ≥80 cm women; triglycerides ≥150 mg/dL; HDL ≤ 40 mg/dL men or ≤50 mg/dL women; systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg; fasting plasma glucose ≥100 mg/dL) at screening.
- non-smoking
Exclusion
- Current tobacco use or use within the previous 6 months
- Diagnosed diabetes or fasting glucose levels \> 126 mg/dL at screening
- Systolic blood pressure \>160 mm Hg or diastolic blood pressure \> 100 mm Hg at screening.
- Use of anti-hypertensive, lipid lowering, glucose lowering drugs, steroids, or antibiotics in the previous month
- History of a cardiovascular event (heart attack, revascularization, stroke), or heart failure, liver, kidney, autoimmune diseases or inflammatory conditions such as gastrointestinal disorders or rheumatoid arthritis
- Use of supplements and botanicals known to affect study outcomes (e.g. psyllium, fish oil, soy lecithin, and phytoestrogens) and not willing to cease for the duration of the study
- Pregnancy, lactation or planning to become pregnant
- Consumption of \>14 alcoholic drinks/week
- Intolerance/allergy/sensitivity to foods included in the study menus
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04487808
Start Date
May 1 2021
End Date
July 1 2022
Last Update
August 18 2023
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