Summary

for people ages 25 years and up (full criteria)
healthy people welcome
at UCLA
study started
estimated completion:
Zhaoping Li (ucla)

Description

Summary

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).

Details

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.

Keywords

Intra-abdominal Fat Metabolic Syndrome High Cholesterol Triglycerides High Diet Habit High Blood Sugar Liver Fat Dietary Modification HDL Cholesterol, Low Serum Cardiovascular Diseases High Density Lipoprotein Deficiency Low-density-lipoprotein-type Cardiovascular Risk Factor Diabetes Metabolic Syndrome X Hypercholesterolemia Hyperglycemia Hypertriglyceridemia Hypolipoproteinemias Hypoalphalipoproteinemias Intervention Daily Avocado

Eligibility

You can join if…

Open to people ages 25 years and up

  • 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.)

You CAN'T join if...

  • 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

Locations

  • University of California Los Angles (UCLA) accepting new patients
    Los Angeles California 90095 United States
  • Loma Linda University accepting new patients
    Loma Linda California 92354 United States

Lead Scientist

  • Zhaoping Li (ucla)
    Associate Chief, Clinical Nutrition

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Wake Forest University Health Sciences
ID
NCT03528031
Study Type
Interventional
Last Updated