Habitual Diet and Avocado Trial (HAT)

Wake Forest University (WFU)

Status: Completed

Conditions: Diet Habit; Dietary Modification; Cardiovascular Diseases; Low-density-lipoprotein-type; HDL Cholesterol, Low Serum; High Cholesterol; Metabolic Syndrome; High Density Lipoprotein Deficiency; Intra-abdominal Fat; Diabetes; Triglycerides High; Liver Fat; High Blood Sugar; Cardiovascular Risk Factor

Treatments: Other: Intervention Daily Avocado

Study type: Interventional

Funder types: Other

Identifiers

NCT03528031

IRB00047011

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 1,008 patients

Sex: All

Ages: 25+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,008 participants in 2 patient groups

Intervention Daily Avocado

Experimental group

Description:

Participants will follow their usual diet and lifestyle but also be provided with 1 avocado to consume per day for 6 months. To maximize compliance, participants will be provided with resources on how to choose, store and ripen avocados along with simple usage ideas. Specific nutrition guidance will not be provided. Participants will pick up fresh avocados every 2 weeks with minimal interaction with study personnel. Compliance visits will be conducted monthly.

Treatment:

Other: Intervention Daily Avocado

Control Usual Diet and Lifestyle

No Intervention group

Description:

Participants will be instructed to follow their usual diet and lifestyle. Participants will be allowed to consume up to 2 avocados per month, but avocado consumption will not be encouraged and no avocados will be provided. Compliance visits will be conducted monthly.