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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).
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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active treatment (AT) diet plan | Experimental | 1 Avocado 7 days/week (5-7 days is acceptable) over a 12 week period |
|
| Control (CT) diet plan | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active | Dietary Supplement | Active Treatment Diet Plan |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in fasting blood glucose response in 12-week intervention of active treatment vs control treatment. | fasting blood glucose response in 12-week intervention | baseline and 12 weeks |
| Changes in fasting blood insulin response in 12-week intervention of active treatment vs control treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in body weight in 12-week intervention of active treatment vs control treatment. | body weight in 12-week intervention | baseline and 12 weeks |
| Changes in waist circumference in 12-week intervention of active treatment vs control treatment. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Britt Britt Burton-Freeman, Ph.D | Illinois Institute of Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Nutrition Research Center | Chicago | Illinois | 60616 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35700149 | Derived | 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. |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| D024821 | Metabolic Syndrome |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Control |
| Dietary Supplement |
Control Diet Plan |
|
fasting blood insulin response in 12-week intervention |
| baseline and 12 weeks |
| Changes in fasting HbA1c response in 12-week intervention of active treatment vs control treatment. | fasting HbA1c response in 12-week intervention | baseline and 12 weeks |
| Changes in blood pressure in 12-week intervention of active treatment vs control treatment. | blood pressure in 12-week intervention | baseline and 12 weeks |
| Changes in fasting blood Triglycerides concentration in 12-week intervention of active treatment vs control treatment. | fasting blood Triglycerides concentration in 12-week intervention | baseline and 12 weeks |
| 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 | baseline and 12 weeks |
| 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 | baseline and 12 weeks |
| 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 | baseline and 12 weeks |
| 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 | baseline and 12 weeks |
| Changes in plasma LDL cholesterol in 12-week intervention of active treatment vs control treatment. | plasma LDL cholesterol in 12-week intervention | baseline and 12 weeks |
| Changes in plasma total cholesterol in 12-week intervention of active treatment vs control treatment. | plasma total cholesterol in 12-week intervention | baseline and 12 weeks |
| Changes in plasma HDL cholesterol in 12-week intervention of active treatment vs control treatment. | plasma HDL cholesterol in 12-week intervention | baseline and 12 weeks |
waist circumference in 12-week intervention
| baseline and 12 weeks |
| Changes in body composition in 12-week intervention of active treatment vs control treatment. | body composition in 12-week intervention | baseline and 12 weeks |
| Changes in blood lipoproteins in 12-week intervention of active treatment vs control treatment. | Changes in lipoprotein particle size/density by nuclear magnetic resonance (NMR) | baseline and 12 weeks |
| Changes in blood IL-6 in 12-week intervention of active treatment vs control treatment. | blood IL-6 in 12-week intervention | baseline and 12 weeks |
| Changes in blood MCP-1 in 12-week intervention of active treatment vs control treatment. | blood MCP-1 in 12-week intervention | baseline and 12 weeks |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |