Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A 12-week, randomized nutrition intervention for the reduction of cardiovascular disease risk factors in a high-risk population in the southeastern United States. The primary objective of this pilot study was to assess the efficacy of a Mediterranean diet intervention (education + extra-virgin olive oil (EVOO) and mixed nut supplementation) versus that of an American Heart Association (AHA) nutrition intervention (education) on serum blood lipid levels as markers for cardiovascular disease risk. Researchers conducting this trial hypothesize that a greater reduction will be seen in cardiovascular disease risk factors in the Mediterranean diet intervention.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mediterranean diet group | Experimental | Participants will receive both nutrition education on patterns of a Mediterranean style diet as well as olive oil and mixed nuts. |
|
| American Heart Association group | Active Comparator | Participants will receive nutrition education on the dietary recommendations for heart health from the American Heart Association. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mediterranean diet | Behavioral | Participants will receive nutrition education and educational materials from a registered dietitian on patients on the patterns of a Mediterranean style diet. Seven education sessions will be delivered through an online platform. Participants will be asked to complete one education session per week for the first six weeks and the final session at week 9. |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure Measurement | Measured in mmHg | Change from at baseline blood pressure to 6-weeks |
| Systolic Blood Pressure Measurement | Measured in mmHg | Change from at baseline blood pressure to 12-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Diastolic Blood Pressure Measurement | Measured in mmHg | Change from at baseline weight to 6-weeks |
| Change in Weight | Measured in kilograms (kg) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael W Greene, PhD | Auburn University | Study Chair |
| Amy W Willis, MS, RD | Auburn University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Auburn University Pharmaceutical Care Center | Auburn | Alabama | 36849 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 9, 2017 |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Olive oil and mixed nuts | Dietary Supplement | Participants in the Mediterranean diet group will receive 3 liters of extra-virgin olive oil and 3 pounds of mixed nuts (1.5 pounds raw almonds and 1.5 pounds raw walnuts) at baseline and at 6 weeks. Participants will be educated by oral and written means, on consumption goals of the nuts and olive oil. |
|
| American Heart Association | Behavioral | Participants will receive nutrition education and educational materials from a registered dietitian on patients on the dietary recommendations from the American Heart Association for heart health. Seven education sessions will be delivered through an online platform. Participants will be asked to complete one education session per week for the first six weeks and the final session at week 9. |
|
| Change from at baseline weight to 12-weeks |
| Calculation of Body Mass Index (BMI) (kg/m∧2) | Height in meters will be combined with weight in kilograms will be combined to report BMI in kg/m∧2) | Change from baseline weight to 6-weeks |
| Calculation of BMI (kg/m∧2) | Height in meters will be combined with weight in kilograms will be combined to report BMI in kg/m∧2) | Change from baseline weight to 12-weeks |
| Concentration of fasted total cholesterol | Measured in mg/dL | Change from baseline weight to 6-weeks |
| Concentration of fasted total cholesterol | Measured in mg/dL | Change from baseline weight to 12-weeks |
| Concentration of fasted high-density lipoprotein (HDL) cholesterol | Measured in mg/dL | Change from baseline weight to 6-weeks |
| Concentration of fasted high-density lipoprotein (HDL) cholesterol | Measured in mg/dL | Change from baseline weight to 12-weeks |
| Concentration of fasted low-density lipoprotein (LDL) cholesterol | Measured in mg/dL | Change from baseline weight to 12-weeks |
| Concentration of fasted low-density lipoprotein (LDL) cholesterol | Measured in mg/dL | Change from baseline weight to 6-weeks |
| Concentration of fasted triglycerides | Measured in mg/dL | Change from baseline weight to 6-weeks |
| Concentration of fasted triglycerides | Measured in mg/dL | Change from baseline weight to 12-weeks |
| A calculation of total cholesterol (mg/dL) to HDL (mg/dL) ratio | Total cholesterol (mg/dL) will be used with HDL (mg/dL) to calculate total cholesterol to HDL ratio | Change from baseline weight to 12-weeks |
| A calculation of total cholesterol (mg/dL) to HDL (mg/dL) ratio | Total cholesterol (mg/dL) will be used with HDL (mg/dL) to calculate total cholesterol to HDL ratio | Change from baseline weight to 6-weeks |
| Concentration of fasted blood glucose | Measured in mg/dL | Change from baseline weight to 6-weeks |
| Concentration of fasted blood glucose | Measured in mg/dL | Change from baseline weight to 12-weeks |
| A calculation of waist (inches) to height (inches) ratio | Waist circumference in inches will be calculated with height measurement in inches to report the waist-to-height ratio | Change from baseline weight to 12-weeks |
| A calculation of waist (inches) to height (inches) ratio | Waist circumference in inches will be calculated with height measurement in inches to report the waist-to-height ratio | Change from baseline weight to 6-weeks |
| Calculation of homeostatic model assessment (HOMA)-insulin resistance (IR) from fasted blood concentrations of fasted blood glucose and fasted insulin | Fasting plasma glucose in mg/dL and fasting serum insulin in milliUnits (mU)/I will be used to calculate HOMA-IR as an indicator for insulin resistance. | Change from baseline weight to 6-weeks |
| Calculation of homeostatic model assessment (HOMA)-insulin resistance (IR) from fasted blood concentrations of fasted blood glucose and fasted insulin | Fasting plasma glucose in mg/dL and fasting serum insulin in mU/I will be used to calculate HOMA-IR as an indicator for insulin resistance. | Change from baseline weight to 12-weeks |
| Sep 21, 2018 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 9, 2017 | Sep 21, 2018 | ICF_001.pdf |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D038441 | Diet, Mediterranean |
| D000069463 | Olive Oil |
| D000572 | American Heart Association |
| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D005224 | Fats, Unsaturated |
| D010938 | Plant Oils |
| D009821 | Oils |
| D005502 | Food |
| D019602 | Food and Beverages |
| D014837 | Voluntary Health Agencies |
| D009939 | Organizations, Nonprofit |
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
Not provided
Not provided