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

Primary Purpose

Pre-diabetes, Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active
Control
Sponsored by
Clinical Nutrition Research Center, Illinois Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pre-diabetes focused on measuring Pre-diabetes, Metabolic syndrome, Matsuda composite index of insulin sensitivity (MISI), Blood glucose, Insulin response, HbA1c, Lipid, Inflammation

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Clinical Nutrition Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active treatment (AT) diet plan

Control (CT) diet plan

Arm Description

1 Avocado 7 days/week (5-7 days is acceptable) over a 12 week period

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

Outcomes

Primary Outcome Measures

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.
insulin sensitivity as measured by the Matsuda composite index

Secondary Outcome Measures

Changes in fasting blood glucose response in 12-week intervention of active treatment vs control treatment.
fasting blood glucose response in 12-week intervention
Changes in fasting blood insulin response in 12-week intervention of active treatment vs control treatment.
fasting blood insulin response in 12-week intervention
Changes in fasting HbA1c response in 12-week intervention of active treatment vs control treatment.
fasting HbA1c response in 12-week intervention
Changes in blood pressure in 12-week intervention of active treatment vs control treatment.
blood pressure in 12-week intervention
Changes in fasting blood Triglycerides concentration in 12-week intervention of active treatment vs control treatment.
fasting blood Triglycerides concentration in 12-week intervention
Changes in fasting hs C-Reactive Protein in 12-week intervention of active treatment vs control treatment.
fasting hs C-Reactive Protein in 12-week intervention
Changes in fasting markers of endothelial dysfunction (ICAM-1) in 12-week intervention of active treatment vs control treatment.
fasting markers of endothelial dysfunction (ICAM-1) in 12-week intervention
Changes in fasting markers of endothelial dysfunction (VCAM-1) in 12-week intervention of active treatment vs control treatment.
fasting markers of endothelial dysfunction (VCAM-1) in 12-week intervention
Changes in attitudes towards eating measured by the Stunkard 3-Factor Eating Questionnaire in 12-week intervention of active treatment vs control treatment.
attitudes towards eating measured by the Stunkard 3-Factor Eating Questionnaire in 12-week intervention
Changes in plasma LDL cholesterol in 12-week intervention of active treatment vs control treatment.
plasma LDL cholesterol in 12-week intervention
Changes in plasma total cholesterol in 12-week intervention of active treatment vs control treatment.
plasma total cholesterol in 12-week intervention
Changes in plasma HDL cholesterol in 12-week intervention of active treatment vs control treatment.
plasma HDL cholesterol in 12-week intervention

Full Information

First Posted
February 22, 2016
Last Updated
June 25, 2021
Sponsor
Clinical Nutrition Research Center, Illinois Institute of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT02695433
Brief Title
Replacing Refined Carbohydrates With Healthy Fats on Cardio-metabolic Markers
Acronym
AV2
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2016 (Actual)
Primary Completion Date
January 20, 2021 (Actual)
Study Completion Date
May 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinical Nutrition Research Center, Illinois Institute of Technology

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-diabetes, Metabolic Syndrome
Keywords
Pre-diabetes, Metabolic syndrome, Matsuda composite index of insulin sensitivity (MISI), Blood glucose, Insulin response, HbA1c, Lipid, Inflammation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active treatment (AT) diet plan
Arm Type
Experimental
Arm Description
1 Avocado 7 days/week (5-7 days is acceptable) over a 12 week period
Arm Title
Control (CT) diet plan
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Active
Intervention Description
Active Treatment Diet Plan
Intervention Type
Dietary Supplement
Intervention Name(s)
Control
Intervention Description
Control Diet Plan
Primary Outcome Measure Information:
Title
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.
Description
insulin sensitivity as measured by the Matsuda composite index
Time Frame
baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Changes in fasting blood glucose response in 12-week intervention of active treatment vs control treatment.
Description
fasting blood glucose response in 12-week intervention
Time Frame
baseline and 12 weeks
Title
Changes in fasting blood insulin response in 12-week intervention of active treatment vs control treatment.
Description
fasting blood insulin response in 12-week intervention
Time Frame
baseline and 12 weeks
Title
Changes in fasting HbA1c response in 12-week intervention of active treatment vs control treatment.
Description
fasting HbA1c response in 12-week intervention
Time Frame
baseline and 12 weeks
Title
Changes in blood pressure in 12-week intervention of active treatment vs control treatment.
Description
blood pressure in 12-week intervention
Time Frame
baseline and 12 weeks
Title
Changes in fasting blood Triglycerides concentration in 12-week intervention of active treatment vs control treatment.
Description
fasting blood Triglycerides concentration in 12-week intervention
Time Frame
baseline and 12 weeks
Title
Changes in fasting hs C-Reactive Protein in 12-week intervention of active treatment vs control treatment.
Description
fasting hs C-Reactive Protein in 12-week intervention
Time Frame
baseline and 12 weeks
Title
Changes in fasting markers of endothelial dysfunction (ICAM-1) in 12-week intervention of active treatment vs control treatment.
Description
fasting markers of endothelial dysfunction (ICAM-1) in 12-week intervention
Time Frame
baseline and 12 weeks
Title
Changes in fasting markers of endothelial dysfunction (VCAM-1) in 12-week intervention of active treatment vs control treatment.
Description
fasting markers of endothelial dysfunction (VCAM-1) in 12-week intervention
Time Frame
baseline and 12 weeks
Title
Changes in attitudes towards eating measured by the Stunkard 3-Factor Eating Questionnaire in 12-week intervention of active treatment vs control treatment.
Description
attitudes towards eating measured by the Stunkard 3-Factor Eating Questionnaire in 12-week intervention
Time Frame
baseline and 12 weeks
Title
Changes in plasma LDL cholesterol in 12-week intervention of active treatment vs control treatment.
Description
plasma LDL cholesterol in 12-week intervention
Time Frame
baseline and 12 weeks
Title
Changes in plasma total cholesterol in 12-week intervention of active treatment vs control treatment.
Description
plasma total cholesterol in 12-week intervention
Time Frame
baseline and 12 weeks
Title
Changes in plasma HDL cholesterol in 12-week intervention of active treatment vs control treatment.
Description
plasma HDL cholesterol in 12-week intervention
Time Frame
baseline and 12 weeks
Other Pre-specified Outcome Measures:
Title
Changes in body weight in 12-week intervention of active treatment vs control treatment.
Description
body weight in 12-week intervention
Time Frame
baseline and 12 weeks
Title
Changes in waist circumference in 12-week intervention of active treatment vs control treatment.
Description
waist circumference in 12-week intervention
Time Frame
baseline and 12 weeks
Title
Changes in body composition in 12-week intervention of active treatment vs control treatment.
Description
body composition in 12-week intervention
Time Frame
baseline and 12 weeks
Title
Changes in blood lipoproteins in 12-week intervention of active treatment vs control treatment.
Description
Changes in lipoprotein particle size/density by nuclear magnetic resonance (NMR)
Time Frame
baseline and 12 weeks
Title
Changes in blood IL-6 in 12-week intervention of active treatment vs control treatment.
Description
blood IL-6 in 12-week intervention
Time Frame
baseline and 12 weeks
Title
Changes in blood MCP-1 in 12-week intervention of active treatment vs control treatment.
Description
blood MCP-1 in 12-week intervention
Time Frame
baseline and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Britt Britt Burton-Freeman, Ph.D
Organizational Affiliation
Illinois Institute of Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Nutrition Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35700149
Citation
Zhang X, Xiao D, Guzman G, Edirisinghe I, Burton-Freeman B. Avocado Consumption for 12 Weeks and Cardiometabolic Risk Factors: A Randomized Controlled Trial in Adults with Overweight or Obesity and Insulin Resistance. J Nutr. 2022 Aug 9;152(8):1851-1861. doi: 10.1093/jn/nxac126.
Results Reference
derived

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Replacing Refined Carbohydrates With Healthy Fats on Cardio-metabolic Markers

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