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Assessing the Value of Avocados on Glycemic Control in Type 2 Diabetes (AVOCADO-T2D)

Primary Purpose

Diabetes Mellitus, Type 2, Insulin, Fructosamine

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Avocado
Other Fruit(s)
Sponsored by
Pennington Biomedical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Participant reported diagnosis of Type 2 diabetes HbA1c between 5.7%-11% (inclusive) and / or fasting blood glucose of ≥ 100 mg/dL BMI 27-50 kg/m2 (inclusive) Age range - 18 - 65 years (inclusive) On stable regimen of all medications (including diabetes) for at least 3 months (brief regimens of medications such as antibiotics, steroids, etc. are permitted) Willing to follow all requirements of study protocol including blood draws Under the care of a physician who will be responsible for managing the subject's diabetes Willing to give release to provide their treating MD with information about the trial Exclusion Criteria: Not willing or unable to consume study foods including avocados Participation in a weight control program within the past 3 months or weight loss of ≥ 5 kg in the previous 3 months Taking prescription or OTC weight loss medications within last 4 weeks History of a surgical procedure for weight loss in last 5 years (e.g. gastroplasty, gastric by-pass, gastrectomy or partial gastrectomy, adjustable banding, gastric sleeve) History of major surgery within three months of enrollment Type 1 diabetes, insulin dependent type 2 diabetes, thiazolidinediones (including rosiglitazone and pioglitazone) Renal insufficiency consisting of potassium over 5.5 (mmol/L) on a non-hemolyzed specimen, or a creatinine over 2.5 mg/dL Bilirubin over 3 (mg/dL) or an albumin less than 3 (g/dL) ALT > 3 (IU/L) times the upper limit of normal (normal range is 7-56) Evidence of more than 1 severe hypoglycemic event (episode requiring emergency medical services) in the past 12 months, unless the participant's treating physician provides written clearance for participation. Those on higher doses of diuretics (furosemide 40mg or higher or comparable) Unstable heart disease (an ongoing workup or treatment for a cardiac symptom such as unstable angina, coronary ischemia) Presence of implanted cardiac defibrillator Blood pressure ≥180/100 mm Hg. If a potential participant has a BP above the inclusion criteria it is acceptable to re-test this potential participant within one week of the original test. Thyroid disease for which the participant is untreated or has had treatment changed within the last 6 months. History of thyroid disease or current thyroid disease treated with a stable medication regimen for at least 6 months is acceptable Uncontrolled gastrointestinal disorders including chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, chronic diarrhea, or active gallbladder disease Current cancer or cancer treatment, or a history of cancer or cancer treatment within the last 3 years. Persons with successfully resected non-melanoma carcinoma of the skin may be enrolled. Dementia, psychiatric illness, or substance abuse that may interfere with adherence (e.g., illness that is currently unstable or resistant to first-line therapy; substance abuse in the past year) Women who are pregnant, lactating, trying to become pregnant or unwilling to use an effective means of birth control Currently consuming >14 alcoholic drinks (1 drink = 12 fl oz beer, 4 fl oz wine or 1.5 fl oz liquor) per week and unwilling to stop intake during study participation Participation in another clinical trial within 30 days prior to enrollment Any other condition or factor which in the opinion of the study physician or investigator makes it inadvisable for the candidate to participate in the trial

Sites / Locations

  • Pennington Biomedical Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Avocado

Other Fruit(s)

Arm Description

Participants will consume 1 Hass avocado a day.

Participants in the other fruit arm will receive other fruits.

Outcomes

Primary Outcome Measures

Fasting Blood Glucose
the primary outcomes are based on within subject concentration change scores

Secondary Outcome Measures

Fasting Insulin
within subject concentration change scores
Fructosamine
within subject concentration change scores
Glycated Albumin
within subject concentration change scores

Full Information

First Posted
July 14, 2023
Last Updated
October 24, 2023
Sponsor
Pennington Biomedical Research Center
Collaborators
Prachi Singh, Frank L. Greenway, Robbie A. Beyl
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1. Study Identification

Unique Protocol Identification Number
NCT05958368
Brief Title
Assessing the Value of Avocados on Glycemic Control in Type 2 Diabetes
Acronym
AVOCADO-T2D
Official Title
The Effects of Hass Avocados on Glycemic Control in Persons With Type 2 Diabetes: A Randomized Controlled Crossover Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 10, 2023 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
December 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center
Collaborators
Prachi Singh, Frank L. Greenway, Robbie A. Beyl

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to assess the effects of Hass Avocados on glycemic control. The investigators hypothesize that Hass Avocado consumption will reduce fasting blood sugar compared to an isocaloric amount of other fruit during controlled feeding.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Insulin, Fructosamine, C-Reactive Protein, Glucose, Overweight and Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This study utilizes a randomized crossover design with each period/treatment being approximately 5 weeks. Participants will be randomized to either Hass Avocado or other fruit(s) consumption groups. The treatments will be isocaloric as will the Hass Avocado vs. the other fruit(s). All subjects will consume a diet provided by the metabolic research kitchen. The diet will be matched on energy (kcal).
Masking
InvestigatorOutcomes Assessor
Masking Description
The investigators and outcome assessors will be blinded to study treatment.
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Avocado
Arm Type
Experimental
Arm Description
Participants will consume 1 Hass avocado a day.
Arm Title
Other Fruit(s)
Arm Type
Active Comparator
Arm Description
Participants in the other fruit arm will receive other fruits.
Intervention Type
Other
Intervention Name(s)
Avocado
Other Intervention Name(s)
Hass Avocado
Intervention Description
The Hass Avocado group will consume 7 avocados a week (1 / day; ~240 kcals/d).
Intervention Type
Other
Intervention Name(s)
Other Fruit(s)
Other Intervention Name(s)
Raisins, Cantaloupe(s), Figs, Pineapple(s), Grapes, Bananas
Intervention Description
The other fruits group will consume fruit(s) matched to the avocado in energy and form (i.e., solid fruit).
Primary Outcome Measure Information:
Title
Fasting Blood Glucose
Description
the primary outcomes are based on within subject concentration change scores
Time Frame
Week 5 - Week 0
Secondary Outcome Measure Information:
Title
Fasting Insulin
Description
within subject concentration change scores
Time Frame
Week 5 - Week 0
Title
Fructosamine
Description
within subject concentration change scores
Time Frame
Week 5 - Week 0
Title
Glycated Albumin
Description
within subject concentration change scores
Time Frame
Week 5 - Week 0
Other Pre-specified Outcome Measures:
Title
Blood Glucose
Description
Continuous Glucose Monitoring
Time Frame
Week 5 - Week 0
Title
Glucose
Description
Oral Glucose Tolerance Test (OGTT)
Time Frame
Week 5 - Week 0
Title
Insulin
Description
Oral Glucose Tolerance Test (OGTT)
Time Frame
Week 5 - Week 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participant reported diagnosis of Type 2 diabetes HbA1c between 5.7%-11% (inclusive) and / or fasting blood glucose of ≥ 100 mg/dL BMI 27-50 kg/m2 (inclusive) Age range - 18 - 65 years (inclusive) On stable regimen of all medications (including diabetes) for at least 3 months (brief regimens of medications such as antibiotics, steroids, etc. are permitted) Willing to follow all requirements of study protocol including blood draws Under the care of a physician who will be responsible for managing the subject's diabetes Willing to give release to provide their treating MD with information about the trial Exclusion Criteria: Not willing or unable to consume study foods including avocados Participation in a weight control program within the past 3 months or weight loss of ≥ 5 kg in the previous 3 months Taking prescription or OTC weight loss medications within last 4 weeks History of a surgical procedure for weight loss in last 5 years (e.g. gastroplasty, gastric by-pass, gastrectomy or partial gastrectomy, adjustable banding, gastric sleeve) History of major surgery within three months of enrollment Type 1 diabetes, insulin dependent type 2 diabetes, thiazolidinediones (including rosiglitazone and pioglitazone) Renal insufficiency consisting of potassium over 5.5 (mmol/L) on a non-hemolyzed specimen, or a creatinine over 2.5 mg/dL Bilirubin over 3 (mg/dL) or an albumin less than 3 (g/dL) ALT > 3 (IU/L) times the upper limit of normal (normal range is 7-56) Evidence of more than 1 severe hypoglycemic event (episode requiring emergency medical services) in the past 12 months, unless the participant's treating physician provides written clearance for participation. Those on higher doses of diuretics (furosemide 40mg or higher or comparable) Unstable heart disease (an ongoing workup or treatment for a cardiac symptom such as unstable angina, coronary ischemia) Presence of implanted cardiac defibrillator Blood pressure ≥180/100 mm Hg. If a potential participant has a BP above the inclusion criteria it is acceptable to re-test this potential participant within one week of the original test. Thyroid disease for which the participant is untreated or has had treatment changed within the last 6 months. History of thyroid disease or current thyroid disease treated with a stable medication regimen for at least 6 months is acceptable Uncontrolled gastrointestinal disorders including chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, chronic diarrhea, or active gallbladder disease Current cancer or cancer treatment, or a history of cancer or cancer treatment within the last 3 years. Persons with successfully resected non-melanoma carcinoma of the skin may be enrolled. Dementia, psychiatric illness, or substance abuse that may interfere with adherence (e.g., illness that is currently unstable or resistant to first-line therapy; substance abuse in the past year) Women who are pregnant, lactating, trying to become pregnant or unwilling to use an effective means of birth control Currently consuming >14 alcoholic drinks (1 drink = 12 fl oz beer, 4 fl oz wine or 1.5 fl oz liquor) per week and unwilling to stop intake during study participation Participation in another clinical trial within 30 days prior to enrollment Any other condition or factor which in the opinion of the study physician or investigator makes it inadvisable for the candidate to participate in the trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John W Apolzan, PhD
Phone
2257632827
Email
John.Apolzan@pbrc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Rob Leonard
Phone
2257630948
Email
doctors@pbrc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John W Apolzan, PhD
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John W Apolzan, PhD
Phone
225-763-2827
Email
john.apolzan@pbrc.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data may be requested. The PI and sponsor will be notified. The proposed research question must be included. All IPD that underlie results in a publication after a DTA with the institution.

Learn more about this trial

Assessing the Value of Avocados on Glycemic Control in Type 2 Diabetes

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