NCT02740439

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 15, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

October 17, 2016

Status Verified

October 1, 2016

Enrollment Period

3 years

First QC Date

April 11, 2016

Last Update Submit

October 14, 2016

Conditions

Obesity, AbdominalInsulin ResistanceInsulin Sensitivity

Outcome Measures

Primary Outcomes (4)

  • Abdominal obesity

    Changes to abdominal and whole body composition including visceral and subcutaneous adipose tissue will be estimated by DEXA.

    Baseline, 4 weeks, 8 weeks, 12 weeks

  • Glycemic Control

    Glycemic control will be assessed using oral glucose tolerance tests and hemoglobin A1c.

    Baseline, 4 weeks, 8 weeks,12 weeks

  • Insulin Resistance

    Insulin resistance will be evaluated using the Homeostasis Assessment Model (HOMA) index.

    Baseline, 4 weeks, 8 weeks, 12 weeks

  • Insulin Sensitivity

    Insulin sensitivity will be assessed using the insulinogenic index, Stumvoll Metabolic Clearance Rate, Oral Glucose Insulin Sensitivity, and the Matsuda Index.

    Baseline, 12 weeks

Secondary Outcomes (14)

  • Gastrointestinal Microbiota Composition and Short Chain Fatty Acids

    Baseline, 4 weeks, 8 weeks, 12 weeks

  • Cognitive Function

    Baseline, 4 weeks, 8 weeks, 12 weeks

  • Retinal Lutein

    Baseline, 4 weeks, 8 weeks, 12 weeks

  • Serum Lutein

    Baseline, 12 weeks

  • Blood Lipid Panel

    Baseline, 12 weeks

  • +9 more secondary outcomes

Study Arms (2)

Intervention Meal

EXPERIMENTAL

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

Other: Avocado

Control Meal

PLACEBO COMPARATOR

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

Other: Control

Interventions

AvocadoOTHER

The intervention meals will contain 1 large avocado.

Intervention Meal
ControlOTHER

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

Control Meal

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois, Urbana-Champaign

Urbana, Illinois, 61801, United States

RECRUITING

Related Publications (5)

  • Hughes RL, Pindus DM, Khan NA, Burd NA, Holscher HD. Associations between Accelerometer-Measured Physical Activity and Fecal Microbiota in Adults with Overweight and Obesity. Med Sci Sports Exerc. 2023 Apr 1;55(4):680-689. doi: 10.1249/MSS.0000000000003096. Epub 2022 Dec 22.

    PMID: 36728974DERIVED

  • Khan NA, Edwards CG, Thompson SV, Hannon BA, Burke SK, Walk ADM, Mackenzie RWA, Reeser GE, Fiese BH, Burd NA, Holscher HD. Avocado Consumption, Abdominal Adiposity, and Oral Glucose Tolerance Among Persons with Overweight and Obesity. J Nutr. 2021 Sep 4;151(9):2513-2521. doi: 10.1093/jn/nxab187.

    PMID: 34191028DERIVED

  • Thompson SV, Bailey MA, Taylor AM, Kaczmarek JL, Mysonhimer AR, Edwards CG, Reeser GE, Burd NA, Khan NA, Holscher HD. Avocado Consumption Alters Gastrointestinal Bacteria Abundance and Microbial Metabolite Concentrations among Adults with Overweight or Obesity: A Randomized Controlled Trial. J Nutr. 2021 Apr 8;151(4):753-762. doi: 10.1093/jn/nxaa219.

    PMID: 32805028DERIVED

  • Edwards CG, Walk AM, Thompson SV, Reeser GE, Erdman JW Jr, Burd NA, Holscher HD, Khan NA. Effects of 12-week avocado consumption on cognitive function among adults with overweight and obesity. Int J Psychophysiol. 2020 Feb;148:13-24. doi: 10.1016/j.ijpsycho.2019.12.006. Epub 2019 Dec 14.

    PMID: 31846631DERIVED

  • Jones AR, Robbs CM, Edwards CG, Walk AM, Thompson SV, Reeser GE, Holscher HD, Khan NA. Retinal Morphometric Markers of Crystallized and Fluid Intelligence Among Adults With Overweight and Obesity. Front Psychol. 2018 Dec 21;9:2650. doi: 10.3389/fpsyg.2018.02650. eCollection 2018.

    PMID: 30622502DERIVED

MeSH Terms

Conditions

Obesity, AbdominalInsulin Resistance

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Hannah D Holscher, PhD RD

    University of Illinois at Urbana-Champaign

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hannah D Holscher, PhD RD

CONTACT

217-300-2512hholsche@illinois.edu

Naiman A Khan, PhD RD

CONTACT

217-300-2197nakhan@illinois.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2016

First Posted

April 15, 2016

Study Start

February 1, 2016

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

October 17, 2016

Record last verified: 2016-10

Locations

US(1)