Replacing Refined Carbohydrates With Healthy Fats on Cardio-metabolic Markers (AV2)

June 25, 2021 updated by: Clinical Nutrition Research Center, Illinois Institute of Technology

Effects of a Typical American Diet High in Refined Carbohydrates Compared to a Diet That Replaces Some Refined Carbohydrates With Healthy Fats on Cardiometabolic Health in Men and Women With Pre-diabetes and Metabolic Syndrome

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The trial is designed as a randomized, controlled, statistician blinded, 2-arm parallel study to investigate the effects of avocado consumption compared to non-avocado control foods which have opposing macronutrients (avocado is relatively higher in fat and in low carbohydrate and the control foods will be low fat, high carbohydrate options) on indices of cardiometabolic health over a 12 week period.

The trial will test 2 treatment conditions in pre-diabetic men and women 25-60 years of age with metabolic syndrome. One hundred twenty men and women will be recruited, aiming for a completer set of 96 subjects. Qualified Subjects will be randomized to receive 1 of 2 test treatments based on randomization schedule from a computer generated randomization schedule.

Study treatments include:

  • Control (CT) diet plan with 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.
  • Active treatment (AT) diet plan will include 1 Avocado 7 days/week (5-7 days is acceptable) over a 12 week period.

Each subject will be asked to come for one Screening Visit, 9 interim food pick-up/compliance visits and 4 Test Day Visits. The four main Test Day visits will occur at week 0 (day 1; baseline), end of week 4, at the end of week 8 and at the end of week 12. Interim Visits will occur at week 1, 2, 3, 5, 6, 7, 9, 10 and 11. Subjects will pick-up study foods, answer questionnaires, receive dietary counseling, confirm diet compliance during interim visits. They will also be asked to complete online 24 hour food recalls up to once per each week of the study. Each of the 4 Test Day Visits will last about 2-3.5 h and involve blood pressure (BP) measurements, a fasting blood sample collection and anthropometric, body composition assessment. In addition, an oral glucose tolerance test (OGTT) will be performed at week 0/day 1 and at the end of week 12/day.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
124

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60616
        • Clinical Nutrition Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Working overnight (e.g 3rd shift of overnight workers)
  • Pregnant, lactating or planning to become pregnant
  • Have donated blood within 3 months of the screening visit and blood donors/participants for whom participation in this study will result in having donated more than 1500 milliliters of blood in the previous 12 months.
  • Women who are taking unstable dose and brand of hormonal contraceptive and/or stable dose and brand less than 6 months
  • Excessive exercisers or trained athletes
  • Take part in chronic feeding or medication clinical trial in the last 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Active treatment (AT) diet plan
1 Avocado 7 days/week (5-7 days is acceptable) over a 12 week period
Dietary supplement: Active
Active Treatment Diet Plan
Placebo Comparator: Control (CT) diet plan
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
Control Diet Plan

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: baseline and 12 weeks
insulin sensitivity as measured by the Matsuda composite index
baseline and 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in fasting blood glucose response in 12-week intervention of active treatment vs control treatment.
Time Frame: baseline and 12 weeks
fasting blood glucose response in 12-week intervention
baseline and 12 weeks
Changes in fasting blood insulin response in 12-week intervention of active treatment vs control treatment.
Time Frame: baseline and 12 weeks
fasting blood insulin response in 12-week intervention
baseline and 12 weeks
Changes in fasting HbA1c response in 12-week intervention of active treatment vs control treatment.
Time Frame: baseline and 12 weeks
fasting HbA1c response in 12-week intervention
baseline and 12 weeks
Changes in blood pressure in 12-week intervention of active treatment vs control treatment.
Time Frame: baseline and 12 weeks
blood pressure in 12-week intervention
baseline and 12 weeks
Changes in fasting blood Triglycerides concentration in 12-week intervention of active treatment vs control treatment.
Time Frame: baseline and 12 weeks
fasting blood Triglycerides concentration in 12-week intervention
baseline and 12 weeks
Changes in fasting hs C-Reactive Protein in 12-week intervention of active treatment vs control treatment.
Time Frame: baseline and 12 weeks
fasting hs C-Reactive Protein in 12-week intervention
baseline and 12 weeks
Changes in fasting markers of endothelial dysfunction (ICAM-1) in 12-week intervention of active treatment vs control treatment.
Time Frame: baseline and 12 weeks
fasting markers of endothelial dysfunction (ICAM-1) in 12-week intervention
baseline and 12 weeks
Changes in fasting markers of endothelial dysfunction (VCAM-1) in 12-week intervention of active treatment vs control treatment.
Time Frame: baseline and 12 weeks
fasting markers of endothelial dysfunction (VCAM-1) in 12-week intervention
baseline and 12 weeks
Changes in attitudes towards eating measured by the Stunkard 3-Factor Eating Questionnaire in 12-week intervention of active treatment vs control treatment.
Time Frame: baseline and 12 weeks
attitudes towards eating measured by the Stunkard 3-Factor Eating Questionnaire in 12-week intervention
baseline and 12 weeks
Changes in plasma LDL cholesterol in 12-week intervention of active treatment vs control treatment.
Time Frame: baseline and 12 weeks
plasma LDL cholesterol in 12-week intervention
baseline and 12 weeks
Changes in plasma total cholesterol in 12-week intervention of active treatment vs control treatment.
Time Frame: baseline and 12 weeks
plasma total cholesterol in 12-week intervention
baseline and 12 weeks
Changes in plasma HDL cholesterol in 12-week intervention of active treatment vs control treatment.
Time Frame: baseline and 12 weeks
plasma HDL cholesterol in 12-week intervention
baseline and 12 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in body weight in 12-week intervention of active treatment vs control treatment.
Time Frame: baseline and 12 weeks
body weight in 12-week intervention
baseline and 12 weeks
Changes in waist circumference in 12-week intervention of active treatment vs control treatment.
Time Frame: baseline and 12 weeks
waist circumference in 12-week intervention
baseline and 12 weeks
Changes in body composition in 12-week intervention of active treatment vs control treatment.
Time Frame: baseline and 12 weeks
body composition in 12-week intervention
baseline and 12 weeks
Changes in blood lipoproteins in 12-week intervention of active treatment vs control treatment.
Time Frame: baseline and 12 weeks
Changes in lipoprotein particle size/density by nuclear magnetic resonance (NMR)
baseline and 12 weeks
Changes in blood IL-6 in 12-week intervention of active treatment vs control treatment.
Time Frame: baseline and 12 weeks
blood IL-6 in 12-week intervention
baseline and 12 weeks
Changes in blood MCP-1 in 12-week intervention of active treatment vs control treatment.
Time Frame: baseline and 12 weeks
blood MCP-1 in 12-week intervention
baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Clinical Nutrition Research Center, Illinois Institute of Technology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Britt Britt Burton-Freeman, Ph.D, Illinois Institute of Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 20, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 1, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB2016-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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