Avocado for Obesity

Not yet recruiting at 1 trial location

Overseen By Caryn Adams

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Midwest Center for Metabolic and Cardiovascular Research

Must not be taking: Diabetes medications, Beta-blockers

Disqualifiers: Metabolic disease, Cancer, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

The objective of this trial is to assess the effects of replacing foods high in refined carbohydrates, particularly added sugars, with avocado (isocaloric substitution) on biomarkers of inflammation and insulin sensitivity in adults with elevated hs-CRP and central adiposity. Eligible participants will complete two 4-week interventions (1 avocado/d and control) separated by a 2-week washout phase. Participants will complete a total of 7 clinic visits including one screening visit (visit 1, -7 days), one baseline visit (visit 2, day 0), two visits during each 4-week diet condition (visit 3 \& 6 on day 21 and visits 4 \& 7 on day 28), and one visit at the conclusion of the washout phase/start of the second condition (visit 5, day 0).

Are You a Good Fit for This Trial?

Inclusion Criteria

My waist is at least 35 inches (woman) or 40 inches (man).

4. Body mass index 25.0 to 39.9 kg/m2;

5. Normally active and judged by the Investigator to be in generally good health, based on medical history and screening measurements;

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline

Participants undergo baseline assessments before starting the intervention

1 day

1 visit (in-person)

First Treatment Phase

Participants consume 1 avocado per day for 4 weeks

4 weeks

2 visits (in-person)

Washout

Participants undergo a 2-week washout period between treatment phases

2 weeks

1 visit (in-person)

Second Treatment Phase

Participants follow the control diet for 4 weeks

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Avocado

How Is the Trial Designed?

Group I: Control Group Experimental Treatment 1 Intervention

3 study products per day will be provided with energy from avocado will be replaced with refined carbohydrate, especially added sugars

Group II: Avocado Group Experimental Treatment 1 Intervention

1 avocado/day provided by 3 servings study products per day (muffins and pudding)

Who Is Running the Clinical Trial?

Midwest Center for Metabolic and Cardiovascular Research

Lead Sponsor

Trials

22

Recruited

880+

Hass Avocado Board

Collaborator

Trials

13

Recruited

760+