Persea Americana for Total Health (PATH ) Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2019-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Abdominal Obesity on Lipoprotein Metabolism

NCT00438061

Obesity Dyslipidemia Insulin Resistance

COMPLETED PHASE3

Characterization of Bile Acid Pathway in Obesity

NCT03341052

Obesity

COMPLETED NA

Anti-inflammatory Effect and Associated Mechanisms of Mango Consumption

NCT04726293

Overweight or Obesity Healthy

COMPLETED NA

The Belly Fat Study: Nutritional Intervention to Improve Metabolic Health in Subjects With Increased Abdominal Adiposity

NCT02194504

Abdominal Obesity Liver Fat

COMPLETED NA

Effect of Weight Loss on Body Composition and Metabolic Function in Women With Lipedema

NCT03271034

Lipedema Metabolism

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The proposed work will investigate the effects of avocados on abdominal obesity and glycemic control among overweight/obese adults. Further, changes in GI microbiota composition and cognitive function will be assessed to comprehensively understand systemic benefits of avocado consumption on gut and brain function. This research study has two aims: 1) To determine the effects of regular avocado intake on metabolic syndrome risk factors, specifically, abdominal obesity and glycemic control, among overweight and obese adults; and 2) to investigate the implications of avocado intake on measures of GI microbiota composition and cognitive function.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity, Abdominal Insulin Resistance Insulin Sensitivity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention Meal

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

Group Type EXPERIMENTAL

Avocado

Intervention Type OTHER

The intervention meals will contain 1 large avocado.

Control Meal

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

Group Type PLACEBO_COMPARATOR

Control

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Avocado

The intervention meals will contain 1 large avocado.

Intervention Type OTHER

Control

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes