Status:
COMPLETED
Nuts and Oil Pilot Study
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Center for Advancing Translational Sciences (NCATS)
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
35+ years
Phase:
NA
Brief Summary
Metabolic syndrome is considered to be a state of prediabetes and is a major risk factor for cardiovascular disease. Dietary interventions involving extra virgin olive oil (EVOO) supplementation and t...
Detailed Description
Metabolic syndrome (MetS) is a collection of at least three out of five cardiometabolic risk factors including abdominal obesity, hypertension, elevated blood glucose, hypertriglyceridemia, and low hi...
Eligibility Criteria
Inclusion
- Men and Women ≥ 35 years of age
- Metabolic syndrome, defined as \> 3 of the following:
- Waist circumference \>102 cm in men and \>88cm in women, triglycerides \>150 mg/dL and/or drug treatment for elevated triglycerides, HDL cholesterol \<40 mg/dL in men and \<50 mg/dL in women and/or drug treatment for reduced HDL cholesterol, systolic blood pressure \>130 mm Hg or diastolic blood pressure \>85 mmHg and/or antihypertensive drug treatment, and fasting glucose \>100 mg/dL or hemoglobin A1c \> 5.6% and/or oral hypoglycemic medications.
- Willing to comply with study visits, as outlined in the protocol
- Able to read and speak English
- No allergies or hypersensitivities to olive oil or nuts
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion
- Plans to move from the study area in the next 12 weeks
- Body Mass Index (BMI) \> 40 kg/m2
- Dementia that is medically documented or suspected, or clinical evidence of cognitive impairment sufficient to impair protocol adherence
- Candidate with any dietary practice, behavior or attitude that would substantially limit ability to adhere to protocol
- Homebound for medical reasons
- Living in the same household with another participant
- Insulin-dependent Diabetes
Key Trial Info
Start Date :
July 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2022
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04361617
Start Date
July 19 2021
End Date
April 20 2022
Last Update
September 18 2023
Active Locations (1)
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1
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157