Recruiting at 1 site No phase Prediabetes

Clinical trial for Prediabetes

Official title Food and Metabolism Study

ClinicalTrials.gov ID: NCT07624500

What this study is testing

What it's testing
The study wants to see whether regular avocado consumption affects triglyceride (blood fat) and glucose (blood sugar) metabolism.
Who it's for
Adults who have prediabetes and insulin resistance.
What's involved
Participants will eat avocados on a regular schedule and have blood tests to measure triglycerides and glucose levels.
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 40 to 70. Healthy volunteers may be eligible.

You may be able to join if

  • Men or women, 40-70 years of age.
  • Fasting triglycerides (TG) \>115 mg/dL.
  • Insulin resistance as measured by Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) \>2.5.
  • Able to provide informed consent.
  • Able to comply with and perform the procedures requested by the protocol, specifically eat all the meals and snacks provided by the study which will...

You likely can't join if

  • Men and women with known or suspected intolerance, allergies or hypersensitivity to study foods or interventions.
  • Fasting blood sugar ≥125 mg/dL. Men and women with blood pressure \>160 mmHg (systolic) / 100 mmHg (diastolic) at the screening visit.
  • Men and women with history of diabetes cardiovascular events, respiratory, renal, gastrointestinal, hepatic or eye disease or surgery- within a year.
  • Men and women who have or had cancer other than non-melanoma skin cancer in the past 5 years.
  • Men and women taking over the counter or prescription medications or dietary supplements that may interfere with study procedures or endpoints.
  • Men and women who are on a specialized diet (vegan, vegetarian, keto, etc.).
See the full eligibility criteria
Who can join
  • Men or women, 40-70 years of age.
  • Fasting triglycerides (TG) \>115 mg/dL.
  • Insulin resistance as measured by Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) \>2.5.
  • Able to provide informed consent.
  • Able to comply with and perform the procedures requested by the protocol, specifically eat all the meals and snacks provided by the study which will be almost all your food (\~ 80% of calories per day).
  • Able to come to the clinic up to 6 times during the study.
  • Able to maintain usual physical activity pattern.
  • Able to avoid/abstain from alcohol and vigorous physical activity for 24 hours prior to and during study visit.
What rules you out
  • Men and women with known or suspected intolerance, allergies or hypersensitivity to study foods or interventions.
  • Fasting blood sugar ≥125 mg/dL. Men and women with blood pressure \>160 mmHg (systolic) / 100 mmHg (diastolic) at the screening visit.
  • Men and women with history of diabetes cardiovascular events, respiratory, renal, gastrointestinal, hepatic or eye disease or surgery- within a year.
  • Men and women who have or had cancer other than non-melanoma skin cancer in the past 5 years.
  • Men and women taking over the counter or prescription medications or dietary supplements that may interfere with study procedures or endpoints.
  • Men and women who are on a specialized diet (vegan, vegetarian, keto, etc.). - - Men and women who consume nuts or peanuts daily or most days of the week.
  • Men and women who are not weight stable (+/-10lbs in previous 2 months). Men and women who have excessive use of drugs or alcohol (ie., addictions) within the past 2 years.
  • Men and women with documented physical or mental disease/condition, which might limit participation in or completion of the study or, that, in the opinion of the investigator, could interfere with the interpretation of...
  • Women who are known to be pregnant or who are intending to become pregnant over the course of the study.
  • Women who are lactating.
  • Major trauma or a surgical event within 2 months (or longer depending on trauma or event) and after consultation with PI. Has used antibiotics within the previous 2 months.
  • History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional.
  • Excessive coffee and tea consumers (\> 4 cups/d).
  • Donated blood within the last 3 months.
  • Women who are taking an unstable dose and brand of hormonal contraceptives and/or a stable dose and brand for less than 6 months.
  • Unusual working hours (working overnight).

The study team makes the final eligibility decision.

Where it is enrolling

  • Chicago, Illinois, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 40 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

This study is enrolling now at Chicago, Illinois, United States. Enter your location above to see the nearest enrolling site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.