Persea Americana for Total Health (PATH ) Study

University of Illinois at Urbana-Champaign

Status: Unknown

Conditions: Obesity, Abdominal; Insulin Resistance; Insulin Sensitivity

Treatments: Other: Avocado; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT02740439

16277

Details and patient eligibility

About

The proposed work will investigate the effects of avocados on abdominal obesity and glycemic control among overweight/obese adults.

Full description

The proposed work will investigate the effects of avocados on abdominal obesity and glycemic control among overweight/obese adults. Further, changes in GI microbiota composition and cognitive function will be assessed to comprehensively understand systemic benefits of avocado consumption on gut and brain function. This research study has two aims: 1) To determine the effects of regular avocado intake on metabolic syndrome risk factors, specifically, abdominal obesity and glycemic control, among overweight and obese adults; and 2) to investigate the implications of avocado intake on measures of GI microbiota composition and cognitive function.

Enrollment: 200 estimated patients

Sex: All

Ages: 25 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Males and females
• Between the ages of 25-45 years at the time of consent
• Body mass index ≥27.5kg/m2
• Normal or corrected-to-normal vision based on the minimal 20/20 standard in order to complete the cognitive task (below 20/20 vision).
• Ability to drop-off fecal sample within 15 minutes of defecation

Exclusion criteria

• Current pregnancy or lactation
• Tobacco use
• Avocado allergy or intolerance
• Food allergies, lactose intolerance
• Latex allergy
• Prior diagnosis of metabolic and gastrointestinal disease (cardiovascular disease and type 1 or type 2 diabetes, chronic constipation, diarrhea, Crohn's disease, celiac disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, hepatitis, HIV, cancer, etc.)
• Prior diagnosis of cognitive or physical disability, including ADHD, severe asthma, epilepsy, chronic kidney disease, and dependence upon a wheelchair/walking
• Use of any anti-psychotic, anti-depressant, anti-anxiety, or ADD/ADHD medications
• Use of medications that alter normal bowel function and metabolism (e.g., recent antibiotic use, laxatives, enemas, anti-diarrheal agents, narcotics, antacids, antispasmodics, diuretics, anticonvulsants).
• High BMI that is not representative of being overweight or obese (e.g. resistance trained individuals, football players)
• Prior malabsorptive bariatric surgery (i.e. gastric bypass, sleeve gastrectomy) or restrictive bariatric surgery (i.e. adjustable gastric band) within the past 2 years

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups, including a placebo group

Intervention Meal

Experimental group

Description:

Intervention meals will contain 1 large avocado and be consumed daily for 12 weeks.

Treatment:

Other: Avocado

Control Meal

Placebo Comparator group

Description:

Control meals will be isocaloric to the intervention meals but without avocado. They will also be consumed daily for 12 weeks.

Treatment:

Other: Control