Recruiting

Persea Americana

Sponsor:

University of Illinois at Urbana-Champaign

Code:

NCT02740439

Conditions

Obesity, Abdominal

Insulin Resistance

Insulin Sensitivity

Eligibility Criteria

Sex: All

Age: 25 - 45

Healthy Volunteers: Accepted

Interventions

Avocado

Control

Study Details

Brief summary:

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

Conditions

Obesity, Abdominal

Insulin Resistance

Insulin Sensitivity

Study ID

NCT02740439

Start date

Feb, 2016

Status verified date

Oct, 2016

Completion date

Feb, 2019

Anticipated

Primary completion date

Feb, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 45

Healthy Volunteers: Accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention Meal

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

placebo comparator: Control Meal

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

Interventions

Avocado

The intervention meals will contain 1 large avocado.

Control

The control meals will be isocaloric to the intervention meals but will not contain avocado.

Primary outcome measure

  • Abdominal obesity [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks ]
  • Glycemic Control [ Time Frame: Baseline, 4 weeks, 8 weeks,12 weeks ]
  • Insulin Resistance [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks ]
  • Insulin Sensitivity [ Time Frame: Baseline, 12 weeks ]

Central Contacts and Locations

Central contacts

Hannah D Holscher, PhD RD

217-300-2512hholsche@illinois.edu

Naiman A Khan, PhD RD

217-300-2197nakhan@illinois.edu

Locations

University of Illinois, Urbana-Champaign

Recruiting

Urbana, Illinois, United States, 61801

Contacts

Ginger Reeser, MS, RD

pathstudy@illinois.edu

More Information

Sponsor

University of Illinois at Urbana-Champaign

Last update posted

Oct 17, 2016

Last verified

Oct, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Illinois at Urbana-Champaign on 2016-10-17.