Habitual Diet and Avocado Trial
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 1000
Summary
- Conditions
- HDL Cholesterol, Low Serum
- Cardiovascular Diseases
- Cardiovascular Risk Factor
- Diabetes
- Diet Habit
- Dietary Modification
- Metabolic Syndrome
- Triglycerides High
- High Blood Sugar
- High Cholesterol
- High Density Lipoprotein Deficiency
- Low-density-lipoprotein-type
- Intra-abdominal Fat
- Liver Fat
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This clinical trial aims to assess the effect of providing one avocado per day on established parameters of health in comparison with a control group maintaining their habitual diets. Participants are pre-screened over the telephone initially to assess eligibility and likelihood of compliance. For those that remain eligible, additional screening is conducted at a study visit. Participants' eligibility is confirmed by the data entry system on the trial website when the Inclusion/Exclusion form is complete and entered. Randomization is performed automatically by the data entry system using a block design and stratified by site. Participants are randomly assigned to one of two equally sized groups. Neither participants nor staff will be blinded to intervention assignment. Both groups are instructed to continue to follow their habitual diet but the intervention group will receive one avocado per day. Participants are followed for outcomes for a six-month period.Masking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 25 years and 125 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT03528031
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: David Reboussin, PhD Wake Forest University Health Sciences
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