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

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ClinicalTrials.gov Identifier: NCT02695433
Recruitment Status : Recruiting
First Posted : March 1, 2016
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
Institute for Food Safety and Health, United States

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 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 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
Study Start Date : March 1, 2016
Estimated Primary Completion Date : October 15, 2019
Estimated Study Completion Date : October 15, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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. [ Time Frame: baseline and 12 weeks ]
    insulin sensitivity as measured by the Matsuda composite index


Secondary Outcome Measures :
  1. Changes in fasting blood glucose response in 12-week intervention of active treatment vs control treatment. [ Time Frame: baseline and 12 weeks ]
    fasting blood glucose response in 12-week intervention

  2. Changes in fasting blood insulin response in 12-week intervention of active treatment vs control treatment. [ Time Frame: baseline and 12 weeks ]
    fasting blood insulin response in 12-week intervention

  3. Changes in fasting HbA1c response in 12-week intervention of active treatment vs control treatment. [ Time Frame: baseline and 12 weeks ]
    fasting HbA1c response in 12-week intervention

  4. Changes in blood pressure in 12-week intervention of active treatment vs control treatment. [ Time Frame: baseline and 12 weeks ]
    blood pressure in 12-week intervention

  5. Changes in fasting blood Triglycerides concentration in 12-week intervention of active treatment vs control treatment. [ Time Frame: baseline and 12 weeks ]
    fasting blood Triglycerides concentration in 12-week intervention

  6. Changes in fasting hs C-Reactive Protein in 12-week intervention of active treatment vs control treatment. [ Time Frame: baseline and 12 weeks ]
    fasting hs C-Reactive Protein in 12-week intervention

  7. Changes in fasting markers of endothelial dysfunction (ICAM-1) in 12-week intervention of active treatment vs control treatment. [ Time Frame: baseline and 12 weeks ]
    fasting markers of endothelial dysfunction (ICAM-1) in 12-week intervention

  8. Changes in fasting markers of endothelial dysfunction (VCAM-1) in 12-week intervention of active treatment vs control treatment. [ Time Frame: baseline and 12 weeks ]
    fasting markers of endothelial dysfunction (VCAM-1) in 12-week intervention

  9. Changes in attitudes towards eating measured by the Stunkard 3-Factor Eating Questionnaire in 12-week intervention of active treatment vs control treatment. [ Time Frame: baseline and 12 weeks ]
    attitudes towards eating measured by the Stunkard 3-Factor Eating Questionnaire in 12-week intervention

  10. Changes in plasma LDL cholesterol in 12-week intervention of active treatment vs control treatment. [ Time Frame: baseline and 12 weeks ]
    plasma LDL cholesterol in 12-week intervention

  11. Changes in plasma total cholesterol in 12-week intervention of active treatment vs control treatment. [ Time Frame: baseline and 12 weeks ]
    plasma total cholesterol in 12-week intervention

  12. Changes in plasma HDL cholesterol in 12-week intervention of active treatment vs control treatment. [ Time Frame: baseline and 12 weeks ]
    plasma HDL cholesterol in 12-week intervention


Other Outcome Measures:
  1. Changes in body weight in 12-week intervention of active treatment vs control treatment. [ Time Frame: baseline and 12 weeks ]
    body weight in 12-week intervention

  2. Changes in waist circumference in 12-week intervention of active treatment vs control treatment. [ Time Frame: baseline and 12 weeks ]
    waist circumference in 12-week intervention

  3. Changes in body composition in 12-week intervention of active treatment vs control treatment. [ Time Frame: baseline and 12 weeks ]
    body composition in 12-week intervention

  4. Changes in blood lipoproteins in 12-week intervention of active treatment vs control treatment. [ Time Frame: baseline and 12 weeks ]
    Changes in lipoprotein particle size/density by nuclear magnetic resonance (NMR)

  5. Changes in blood IL-6 in 12-week intervention of active treatment vs control treatment. [ Time Frame: baseline and 12 weeks ]
    blood IL-6 in 12-week intervention

  6. Changes in blood MCP-1 in 12-week intervention of active treatment vs control treatment. [ Time Frame: baseline and 12 weeks ]
    blood MCP-1 in 12-week intervention



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women aged 25-60 yrs.
  • BMI of 25 - 40 kg/m2
  • Pre-diabetic: Fasting venous blood glucose of 100-125.9 mg/dl
  • HOMA-IR ≥ 3
  • Metabolic Syndrome: Have 2 out of the following 4 criteria:

    • Abdominal obesity: mid-point waist circumference >102 cm for men and >88 cm for women
    • High triglycerides: ≥ 150mg/dl
    • Low HDL-Cholesterol: <40 mg/dl for men and <50 mg/dl for women
    • High blood pressure: Systolic BP ≥130 mm Hg or diastolic BP ≥85 mm Hg
  • 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 > 60 years
  • BMI < 25 kg/m2 or > 40 kg/m2
  • Fasting blood glucose < 100 or > 125.9 mg/dl (venous blood)
  • HOMA-IR < 3
  • 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 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
  • Does not take part in chronic feeding or medication clinical trial in the last 3 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02695433


Contacts
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Contact: Eunyoung Park, M.S 3125675307 epark4@iit.edu
Contact: Indika Edirisinghe, Ph.D 708-563-8178 iedirisi@iit.edu

Locations
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United States, Illinois
Clinical Nutrition Research Center Recruiting
Chicago, Illinois, United States, 60616
Contact: Eunyoung Park, MS, RD    312-567-5307    epark4@iit.edu   
Contact: Indika Edirisinghe, Ph.D    708-308-0178    iedirisi@iit.edu   
Sponsors and Collaborators
Institute for Food Safety and Health, United States
Investigators
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Principal Investigator: Britt Britt Burton-Freeman, Ph.D Illinois Institute of Technology

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Responsible Party: Institute for Food Safety and Health, United States
ClinicalTrials.gov Identifier: NCT02695433     History of Changes
Other Study ID Numbers: IRB2016-001
First Posted: March 1, 2016    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Institute for Food Safety and Health, United States:
Pre-diabetes
Metabolic syndrome
Matsuda composite index of insulin sensitivity (MISI)
Blood glucose
Insulin response
HbA1c
Lipid
Inflammation

Additional relevant MeSH terms:
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Metabolic Syndrome
Syndrome
Prediabetic State
Glucose Intolerance
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Hyperglycemia