Auburn University Pharmaceutical Care Center
Auburn, Alabama, 36849, United States
NCT Number: NCT03683134
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.
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Notify Me19 year and older
All sexes
Interventional
Not applicable
Auburn, Alabama, 36849, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: Change from at baseline blood pressure to 6-weeks
Measured in mmHg
Time frame: Change from at baseline blood pressure to 12-weeks
Measured in mmHg
Time frame: Change from at baseline weight to 6-weeks
Measured in mmHg
Time frame: Change from at baseline weight to 12-weeks
Measured in kilograms (kg)
Time frame: Change from baseline weight to 6-weeks
Height in meters will be combined with weight in kilograms will be combined to report BMI in kg/m∧2)
Time frame: Change from baseline weight to 12-weeks
Height in meters will be combined with weight in kilograms will be combined to report BMI in kg/m∧2)
Time frame: Change from baseline weight to 6-weeks
Measured in mg/dL
Time frame: Change from baseline weight to 12-weeks
Measured in mg/dL
Time frame: Change from baseline weight to 6-weeks
Measured in mg/dL
Time frame: Change from baseline weight to 12-weeks
Measured in mg/dL
Time frame: Change from baseline weight to 12-weeks
Measured in mg/dL
Time frame: Change from baseline weight to 6-weeks
Measured in mg/dL
Time frame: Change from baseline weight to 6-weeks
Measured in mg/dL
Time frame: Change from baseline weight to 12-weeks
Measured in mg/dL
Time frame: Change from baseline weight to 12-weeks
Total cholesterol (mg/dL) will be used with HDL (mg/dL) to calculate total cholesterol to HDL ratio
Time frame: Change from baseline weight to 6-weeks
Total cholesterol (mg/dL) will be used with HDL (mg/dL) to calculate total cholesterol to HDL ratio
Time frame: Change from baseline weight to 6-weeks
Measured in mg/dL
Time frame: Change from baseline weight to 12-weeks
Measured in mg/dL
Time frame: Change from baseline weight to 12-weeks
Waist circumference in inches will be calculated with height measurement in inches to report the waist-to-height ratio
Time frame: Change from baseline weight to 6-weeks
Waist circumference in inches will be calculated with height measurement in inches to report the waist-to-height ratio
Time frame: Change from baseline weight to 6-weeks
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.
Time frame: Change from baseline weight to 12-weeks
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.
Auburn University
Other
A Pilot, Theory-Based, Nutrition Intervention Promoting a Mediterranean Diet for the Reduction of Cardiovascular Disease Risk Factors in a High-Risk Population of the Southeastern United States: The Healthy Hearts Program (HHP)
Acronym: HHP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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