NCT03528031

Habitual Diet and Avocado Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,008 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 25 Years
• Healthy volunteers: Accepted

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).

Detailed 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.

Conditions

• 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

Interventions

Type	Name	Description
OTHER	Intervention Daily Avocado	Participants follow their usual diet and lifestyle but also are provided with 1 avocado to consume per day for 6 months.

Timeline

• Start date: 2018-06-19
• Primary completion: 2020-10-16
• Completion: 2020-10-30
• First posted: 2018-05-17
• Last updated: 2023-03-22

Locations

4 sites across 1 country: United States