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

Sponsor

Clinical Nutrition Research Center, Illinois Institute of Technology (Industry)

Overall Status

Completed

CT.gov ID

NCT02695433

Collaborator

(none)

124

Enrollment

Location

Arms

62.5

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Pre-diabetes Metabolic Syndrome	Dietary Supplement: Active Dietary Supplement: Control	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

124 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Basic Science

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

Actual Study Start Date :

Mar 1, 2016

Actual Primary Completion Date :

Jan 20, 2021

Actual Study Completion Date :

May 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active treatment (AT) diet plan 1 Avocado 7 days/week (5-7 days is acceptable) over a 12 week period	Dietary Supplement: Active Active Treatment Diet Plan
Placebo Comparator: Control (CT) diet plan 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	Dietary Supplement: Control Control Diet Plan

Arm

Intervention/Treatment

Experimental: Active treatment (AT) diet plan

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

Dietary Supplement: Active

Active Treatment Diet Plan

Placebo Comparator: Control (CT) diet plan

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

Dietary Supplement: Control

Control Diet Plan

Outcome Measures

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. [baseline and 12 weeks]
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. [baseline and 12 weeks]
fasting blood glucose response in 12-week intervention
Changes in fasting blood insulin response in 12-week intervention of active treatment vs control treatment. [baseline and 12 weeks]
fasting blood insulin response in 12-week intervention
Changes in fasting HbA1c response in 12-week intervention of active treatment vs control treatment. [baseline and 12 weeks]
fasting HbA1c response in 12-week intervention
Changes in blood pressure in 12-week intervention of active treatment vs control treatment. [baseline and 12 weeks]
blood pressure in 12-week intervention
Changes in fasting blood Triglycerides concentration in 12-week intervention of active treatment vs control treatment. [baseline and 12 weeks]
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. [baseline and 12 weeks]
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. [baseline and 12 weeks]
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. [baseline and 12 weeks]
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. [baseline and 12 weeks]
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. [baseline and 12 weeks]
plasma LDL cholesterol in 12-week intervention
Changes in plasma total cholesterol in 12-week intervention of active treatment vs control treatment. [baseline and 12 weeks]
plasma total cholesterol in 12-week intervention
Changes in plasma HDL cholesterol in 12-week intervention of active treatment vs control treatment. [baseline and 12 weeks]
plasma HDL cholesterol in 12-week intervention

Other Outcome Measures

Changes in body weight in 12-week intervention of active treatment vs control treatment. [baseline and 12 weeks]
body weight in 12-week intervention
Changes in waist circumference in 12-week intervention of active treatment vs control treatment. [baseline and 12 weeks]
waist circumference in 12-week intervention
Changes in body composition in 12-week intervention of active treatment vs control treatment. [baseline and 12 weeks]
body composition in 12-week intervention
Changes in blood lipoproteins in 12-week intervention of active treatment vs control treatment. [baseline and 12 weeks]
Changes in lipoprotein particle size/density by nuclear magnetic resonance (NMR)
Changes in blood IL-6 in 12-week intervention of active treatment vs control treatment. [baseline and 12 weeks]
blood IL-6 in 12-week intervention
Changes in blood MCP-1 in 12-week intervention of active treatment vs control treatment. [baseline and 12 weeks]
blood MCP-1 in 12-week intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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