The objective of this trial is to assess the effects of replacing foods high in refined carbohydrates, particularly added sugars, with avocado (isocaloric substitution) on biomarkers of inflammation and insulin sensitivity in adults with elevated hs-CRP and central adiposity. Eligible participants will complete two 4-week interventions (1 avocado/d and control) separated by a 2-week washout phase. Participants will complete a total of 7 clinic visits including one screening visit (visit 1, -7 days), one baseline visit (visit 2, day 0), two visits during each 4-week diet condition (visit 3 \& 6 on day 21 and visits 4 \& 7 on day 28), and one visit at the conclusion of the washout phase/start of the second condition (visit 5, day 0).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
38
Active foods will provide the equivalent of one medium to large avocado/day in foods such as muffins and pudding, where avocado replaces refined carbohydrate, especially added sugars
Control foods will have similar energy contents to active foods, but energy from avocado will be replaced with refined carbohydrate, especially added sugars.
Illinois Institute of Technology
Chicago, Illinois, United States
University of Nevada, Las Vegas
Las Vegas, Nevada, United States
Composite measure of inflammatory biomarkers
Change from baseline for a composite measure of inflammatory biomarkers including high-sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6), interleukin-1 beta (IL-1β), interleukin-10 (IL-10), and tumor Necrosis Factor-alpha (TNF-α).
Time frame: Change from baseline (day 0) to end of each condition (day 28)
Homeostasis model assessments of insulin resistance (HOMA-IR)
Changes in (HOMA-IR)
Time frame: Change from baseline (day 0) to end of each condition (day 28)
Homeostasis model assessments of β-cell function (HOMA-B)
Changes in HOMA-B
Time frame: Change from baseline (day 0) to end of each condition (day 28)
Matsuda index of insulin sensitivity
Change in Matsuda index of insulin sensitivity
Time frame: Change from baseline (day 0) to end of each condition (day 28)
Disposition index
Change in disposition index
Time frame: Change from baseline (day 0) to end of each condition (day 28)
high sensitivity C-reactive protein (hs-CRP)
Change in hs-CRP
Time frame: Change from baseline (day 0) to end of each condition (day 28)
Interleukin-6 (IL-6)
Change in IL-6
Time frame: Change from baseline (day 0) to end of each condition (day 28)
Interleukin-1 beta (IL-1β)
Change in IL-1β
Time frame: Change from baseline (day 0) to end of each condition (day 28)
Interleukin-10 (IL-10)
Change in IL-10
Time frame: Change from baseline (day 0) to end of each condition (day 28)
Tumor Necrosis Factor-alpha (TNF-α)
Change in TNF-α
Time frame: Change from baseline (day 0) to end of each condition (day 28)
Fibrinogen
Change in fibrinogen
Time frame: Change from baseline (day 0) to end of each condition (day 28)
Soluble Intercellular Adhesion Molecule-1 (sICAM-1)
Change in sICAM-1
Time frame: Change from baseline (day 0) to end of each condition (day 28)
Soluble Vascular Cell Adhesion Molecule-1 (sVCAM-1)
Change in sVCAM-1
Time frame: Change from baseline (day 0) to end of each condition (day 28)
Total Cholesterol
Change in total cholesterol
Time frame: Change from baseline (day 0) to end of each condition (day 28)
Low-density lipoprotein cholesterol (LDL-C)
Change in LDL-C
Time frame: Change from baseline (day 0) to end of each condition (day 28)
High-density lipoprotein cholesterol (HDL-C)
Change in HDL-C
Time frame: Change from baseline (day 0) to end of each condition (day 28)
Non-high-density lipoprotein cholesterol (non-HDL-C)
Change in non-HDL-C
Time frame: Change from baseline (day 0) to end of each condition (day 28)
Triglycerides
Change in triglycerides
Time frame: Change from baseline (day 0) to end of each condition (day 28)
Apolipoprotein B (ApoB)
Change in ApoB
Time frame: Change from baseline (day 0) to end of each condition (day 28)
Systolic and diastolic blood pressures.
Change in resting, seated systolic and diastolic blood pressures.
Time frame: Change from baseline (day 0) to end of each condition (day 28)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.