Replacing Refined Carbohydrates With Healthy Fats on Cardio-metabolic Markers

Completed · Not applicable

Conditions studied: Pre-diabetes, Metabolic Syndrome

In brief

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).

Key facts

Study ID

NCT02695433

Run by

Clinical Nutrition Research Center, Illinois Institute of Technology

People needed

124

Starts

2016-03-01

Expected to finish

2021-05-15

Last updated by the study team

2021-06-29

Who can join

Age: 25 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Clinical Nutrition Research Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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