N/A N=34 Randomized Single-blind Basic Science

Nuts and Oil Pilot Study

Metabolic Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT04361617 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2023

Primary outcome: Primary: Proportion of Participants With MetS With Epigenetic Age Acceleration — 0.21; 0.53 proportion of participants AgeAccelGrim>

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Daily consumption of tree nuts and extra virgin olive oil (Behavioral)
Age: Adult, Older Adult · 35+ yrs
Sex: All
Sponsor: Wake Forest University Health Sciences
Primary completion: Apr 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Participants With MetS With Epigenetic Age Acceleration	0.21; 0.53	—
PRIMARY Proportion of Days for Which EVOO Was Taken	0.96; 0.97	—
PRIMARY Proportion of Days for Which Nuts Were Taken	0.997; 0.997	—
PRIMARY Proportion of Days for Which Nuts and EVOO Were Taken	0.948; 0.967	—
PRIMARY Percentage of Participants Would be Able to Continue Eating the Tree Nuts and EVOO for a Study Like This Lasting 3-4 Years	76; 93	—
SECONDARY Changes in Epigenetic Age Acceleration	-0.2; 0.1	—

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 tree nut consumption can improve cardiometabolic health and reverse metabolic syndrome. The goal of this exploratory study is to establish the feasibility of using a novel measure - epigenetic age - to motivate behavior change and improve cardiometabolic health in individuals with metabolic syndrome.

Eligibility Criteria

Inclusion Criteria

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 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 Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04361617). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.