NCT02695433

Brief Summary

The primary goal is to to characterize the effects of consuming 1 avocado fruit 7 days / week (5-7 days is acceptable) compared to a no avocado relatively low fat, carbohydrate control treatment over a 12 week period on insulin sensitivity as measured by the Matsuda composite index of insulin sensitivity (MISI).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 22, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2021

Completed
Last Updated

June 29, 2021

Status Verified

June 1, 2021

Enrollment Period

4.9 years

First QC Date

February 22, 2016

Last Update Submit

June 25, 2021

Conditions

Pre-diabetesMetabolic Syndrome

Keywords

Pre-diabetesMetabolic syndromeMatsuda composite index of insulin sensitivity (MISI)Blood glucoseInsulin responseHbA1cLipidInflammation

Outcome Measures

Primary Outcomes (1)

  • Changes in insulin sensitivity as measured by the Matsuda composite index of insulin sensitivity (MISI) in 12-week intervention of active treatment vs control treatment.

    insulin sensitivity as measured by the Matsuda composite index

    baseline and 12 weeks

Secondary Outcomes (12)

  • Changes in fasting blood glucose response in 12-week intervention of active treatment vs control treatment.

    baseline and 12 weeks

  • Changes in fasting blood insulin response in 12-week intervention of active treatment vs control treatment.

    baseline and 12 weeks

  • Changes in fasting HbA1c response in 12-week intervention of active treatment vs control treatment.

    baseline and 12 weeks

  • Changes in blood pressure in 12-week intervention of active treatment vs control treatment.

    baseline and 12 weeks

  • Changes in fasting blood Triglycerides concentration in 12-week intervention of active treatment vs control treatment.

    baseline and 12 weeks

  • +7 more secondary outcomes

Other Outcomes (6)

  • Changes in body weight in 12-week intervention of active treatment vs control treatment.

    baseline and 12 weeks

  • Changes in waist circumference in 12-week intervention of active treatment vs control treatment.

    baseline and 12 weeks

  • Changes in body composition in 12-week intervention of active treatment vs control treatment.

    baseline and 12 weeks

  • +3 more other outcomes

Study Arms (2)

Active treatment (AT) diet plan

EXPERIMENTAL

1 Avocado 7 days/week (5-7 days is acceptable) over a 12 week period

Dietary Supplement: Active

Control (CT) diet plan

PLACEBO COMPARATOR

at least 1 serving of a low fat, low fiber, high glycemic carbohydrate and eliminate avocado 7 days / week (5-7 days is acceptable) over a 12 week period

Dietary Supplement: Control

Interventions

ActiveDIETARY_SUPPLEMENT

Active Treatment Diet Plan

Active treatment (AT) diet plan
ControlDIETARY_SUPPLEMENT

Control Diet Plan

Control (CT) diet plan

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men and women aged 25-65 yrs.
  • BMI of 25 - 42 kg/m2
  • HOMA-IR ≥ 2
  • Abdominal obesity: mid-point waist circumference \>102 cm for men and \>88 cm for women
  • No clinical evidence / history of heart disease, respiratory, renal, gastrointestinal, or hepatic disease
  • Not taking over-the-counter or prescription medications/dietary supplements that may interfere with study procedures or endpoints (e.g., antioxidant supplements, protein powder, energy drinks, anti-inflammatory or lipid-lowering medications).
  • Non-smoker or past smoker (smoking cessation \> 2 yrs.)
  • Able to provide informed consent and comply with study procedures

You may not qualify if:

  • Aged \< 25 or \> 65 years
  • BMI \< 25 kg/m2 or \> 42 kg/m2
  • HOMA-IR \< 2.0
  • History of heart disease, respiratory, renal, gastrointestinal or hepatic disease
  • Diabetes
  • Have or had cancer other than non-melanoma skin cancer in past 5 years
  • Taking over-the-counter or prescription medications or dietary supplements that may interfere with study procedures or endpoints (including protein powers, energy drinks)
  • Vegan dietary habits, unusual dietary habits or sensitive or allergic to any of the test meal components / ingredients
  • Consuming 3 or more avocados per week.
  • Consuming 3 or more servings of nuts or peanuts per week, unless subject is willing to stop consuming nuts 4 weeks before and throughout the course of the study.
  • Excessive coffee and tea consumers (\>4 cups/day)
  • Current smoker
  • Actively losing weight or trying to lose weight (unstable body weight fluctuations of \> 5 kg in 3 months
  • Drug or alcohol addiction
  • Present with significant psychiatric or neurological disturbances
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Nutrition Research Center

Chicago, Illinois, 60616, United States

Location

Related Publications (1)

  • Zhang X, Xiao D, Guzman G, Edirisinghe I, Burton-Freeman B. Avocado Consumption for 12 Weeks and Cardiometabolic Risk Factors: A Randomized Controlled Trial in Adults with Overweight or Obesity and Insulin Resistance. J Nutr. 2022 Aug 9;152(8):1851-1861. doi: 10.1093/jn/nxac126.

    PMID: 35700149DERIVED

MeSH Terms

Conditions

Glucose IntoleranceMetabolic SyndromeInflammation

Interventions

Exercise

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesInsulin ResistanceHyperinsulinismPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Britt Britt Burton-Freeman, Ph.D

    Illinois Institute of Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2016

First Posted

March 1, 2016

Study Start

March 1, 2016

Primary Completion

January 20, 2021

Study Completion

May 15, 2021

Last Updated

June 29, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)