Habitual Diet and Avocado Trial



Status:Recruiting
Conditions:High Cholesterol, Peripheral Vascular Disease, Endocrine, Diabetes, Metabolic
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology, Pharmacology / Toxicology
Healthy:No
Age Range:25 - Any
Updated:9/2/2018
Start Date:June 19, 2018
End Date:January 2022
Contact:Letitia Perdue, MS
Email:lperdue@wakehealth.edu
Phone:(336) 716-1336

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The Habitual Diet and Avocado Trial will evaluate the effects of providing one avocado per
day for recommended consumption over a 6 month period in a cohort of approximately 1000
free-living participants with increased waist circumference in comparison with a control
group that will maintain their habitual diets. Participants will be recruited and screened at
4 clinics in 4 locations: Pennsylvania State University; Loma Linda University; UCLA, and
Tufts University (250 per site).

Preliminary evidence suggests that consumption of avocados can modulate body weight, food
intake and markers of metabolic syndrome and may reduce visceral adiposity. Visceral adipose
tissue is positively correlated with risk of cardiometabolic syndrome that predisposes to
cardiovascular disease and diabetes. The Habitual Diet and Avocado Trial (HAT) aims to
investigate an impactful outcome (visceral fat reduction) in a relevant population (Americans
with an increased weight circumference) with a reasonable lifestyle modification (consumption
of 1 avocado per day). HAT will evaluate the effect of providing one avocado per day for
consumption over a 6 month period on established health parameters, including visceral
adiposity, hepatic lipid content, markers of metabolic syndrome and high sensitivity
C-reactive protein (hsCRP) when compared to a habitual diet. Blood specimens will be drawn
and analyzed for fasting total cholesterol, triglyceride, HDL-C, glucose, insulin, hsCRP and
RBC fatty acid profiles. Two non-contrast MRIs will be performed (at screening to assess
eligibility and final participant visit 8 for randomized participants) to assess the volume
of visceral adipose tissue and hepatic fat fraction. Four 24-hour dietary recalls will be
conducted for study participants to capture dietary intake data. Questionnaires include the
following: health and demographic including eating habits and physical activity; diet, food
and avocado satisfaction (intervention group only); quality of life; and quality of sleep.

Inclusion Criteria:

- Increased waist circumference defined as ≥35 inches for women, ≥40 inches for men

- At least 25 years old at screening

- Not currently eating more than 2 avocados per month (habitual intake in U.S.)

Exclusion Criteria:

- Does not eat avocados

- Sensitive / allergic to avocados

- Allergies to latex or oral allergy syndrome

- Not willing or unable to undergo MRI scans

- Unstable medical condition such as on dialysis for renal disease, cardiac,
gastrointestinal, or hepatic disease, cancer (non-melanoma skin cancer >5 years ago
acceptable, any cancer site >10yrs without recurrence).

- Pregnant, lactating, intention of pregnancy

- Lost or gained 10 lbs of body weight in last year

- Following restricted or weight loss dietary patterns

- Unstable anti-anxiety / anti-depressive / anti-psychotic medication use defined as
dose change within last 6 months

- Oral steroid use within the last 6 months longer than 7 days

- Elevated alcohol intake (7+ drinks/week females; 14+ drinks/week males)

- Participation in another clinical intervention trial within 30 days of baseline

- PI judgment
We found this trial at
4
sites
30 Lower Campus Road
Medford, Massachusetts 02155
Principal Investigator: Alice Lichtenstein, D.Sc.
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Loma Linda University
Loma Linda, California 92354
(909) 558-4000
Principal Investigator: Joan Sabate, MD, DrPH
Loma Linda University Loma Linda University (LLU) is a Seventh-day Adventist educational health-sciences institution with...
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Los Angeles, California 90095
Principal Investigator: Zhaoping Li, MD, PhD
Phone: 310-206-2962
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Los Angeles, CA
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University Park, Pennsylvania 16802
Principal Investigator: Penny Kris-Etherton, PhD, RD
Phone: 814-863-8056
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University Park, PA
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