Post-prandial Effects of Extra Virgin Olive Oil on Endothelial Function in Adults at Risk for Type 2 Diabetes

NCT04025281 | Completed

• 1 other identifier: 2018-12
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: The number of cases of adults with Type 2 diabetes has quadrupled since 1980. This increase in the number of cases of diabetes is attributed to changes in dietary patterns, which include an increase in the consumption of obesogenic foods such as sugary foods and beverages. Patients with diabetes or at risk for diabetes are more likely to develop a cardiovascular event. Though glycemic control remains the basis of diabetes care, the co-management of atherosclerosis, hypertension and cardiovascular risk reduction, and prevention of long-term consequences are also important predictable measures to improve survival. The progression from prediabetes to Type 2 diabetes and complications of diabetes could be prevented. Lifestyle interventions (i.e., nutrition and physical activity) are the cornerstone for the primary prevention of Type 2 diabetes. Healthful eating can also improve cardio-metabolic risk factors associated with those at risk for or Type 2 diabetes. Foods that are low in fat and calories and high in fiber, with a focus on fruit, vegetables, whole grains, and the inclusion of healthful oils in their diets are typically recommended to prevent the progression from prediabetes to diabetes and complications of diabetes. Diets rich in mono- and polyunsaturated fatty acids have been shown to improve cardio-metabolic health in those at risk for or with Type 2 diabetes patients. However, the effect of olive oils on endothelial function (a surrogate marker of cardiovascular risk) in adults at risk for Type 2 diabetes is controversial. Refined olive oils lack important antioxidants and anti-inflammatory properties. Extra virgin olive oils have relatively higher levels of some minor phenolic compounds, and more naturally-occurring minerals and vitamins found in olives, that are essential to improve cardio-metabolic risk factors in those at risk for or with Type 2 diabetes. We propose a prospective, randomized, controlled crossover study to assess the post-prandial effects of extra virgin olive oil, versus post-prandial effects of a refined olive oil, on endothelial function and blood pressure in adults at risk for Type 2 diabetes. Specific Aims To assess the post-prandial effect of extra virgin olive oil on endothelial function, measured as flow mediated dilatation, in adults at risk for Type 2 diabetes. Specifically, to demonstrate at least a 3.5% improvement in endothelial function following the consumption of a meal with 50 mL of extra virgin olive oil, compared with a meal with 50 mL of refined olive oil, in individuals at risk for Type 2 diabetes. To assess the post-prandial effect of extra virgin olive oil on blood pressure in adults at risk for Type 2 diabetes. Specifically, to demonstrate at least 3 mmHg improvements in systolic and diastolic blood pressure after the consumption of a meal with 50 mL of extra virgin olive oil compared with a meal with 50 mL of refined olive oil, in individuals at risk for Type 2 diabetes. Hypotheses Consumption of a meal with extra virgin olive oil compared with a meal with refined olive oil will show superior benefits in endothelial function in adults at risk for Type 2 diabetes. Consumption of a meal with extra virgin olive oil compared with a meal with refined olive oil will show better improvement in blood pressure in adults at risk for Type 2 diabetes.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Endothelial Function (EF) Assessment

  Endothelial function will be measured as Flow-mediated dilatation (FMD), that is the percent change in brachial artery diameter from pre-cuff inflation to 60-seconds post-cuff release. In addition to brachial diameter at 60 seconds post-cuff release, flow after cuff deflation within the first 15 seconds will be used as an indicator of stimulus strength, hyperemic flow being the stimulus for endothelial reactivity. To account for potential variability in stimulus strength, a secondary analysis will be performed in which FMD is divided by flow at 15 seconds post-cuff deflation to create a stimulus-adjusted response measure.

  2 hours

Secondary Outcomes (1)

• Office Blood Pressure

  2 hours

Study Arms (2)

Extra virgin olive oil

ACTIVE COMPARATOR

Participants will consume a meal prepared with 50 mL extra virgin olive oil. The meals will be prepared and provided to the study participants in the cafeteria of Griffin Hospital, where the Prevention Research Center is located. With the exception of the type of olive oil used in the meals, the meal plan will be comparable in all the intervention phases for the same individual.

Other: Extra Virgin Olive Oil

Refined olive oil

ACTIVE COMPARATOR

Participants will consume a meal prepared with 50 mL refined olive oil in the cafeteria of Griffin Hospital. With the exception of the olive oil used, the meal plan will be comparable in each the intervention phases for the same individual.

Other: Refined Olive Oil

Interventions

Extra Virgin Olive Oil OTHER

Participants will consume a meal prepared with 50 mL extra virgin olive oil. The meals will be prepared and provided to the study participants in the cafeteria of Griffin Hospital, where the Prevention Research Center is located. With the exception of the type of olive oil used in the meals, the meal plan will be comparable in all the intervention phases for the same individual.

Extra virgin olive oil

Refined Olive Oil OTHER

Participants will consume a meal prepared with 50 mL refined olive oil in the cafeteria of Griffin Hospital. With the exception of the olive oil used, the meal plan will be comparable in each the intervention phases for the same individual.

Refined olive oil

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female age 25-75 years;
• non-smokers;
• post-menopausal females not currently on hormone replacement therapy;
• at risk for Type 2 diabetes as defined by meeting at least one of the criteria listed below: (a) metabolic syndrome, i.e. meet 3 out of 5 of the following criteria: (i) blood pressure \>130/85 mmHg or currently taking antihypertensive medication; (ii) fasting plasma glucose (FPG) \>100 mg/dL (6.1 mmol/L); (iii) serum triglycerides level (TG)\>150 mg/dL (1.69 mmol/L); (iv) high-density lipoprotein (HDL) cholesterol \< 40 mg/dL (1.04 mmol/L) in men, and \< 50 mg/dL (1.29 mmol/L) in women; (v) overweight (body mass index, or BMI ≥25kg/m²) with waist circumference of more than 40 inches (102 cm) for men and more than 35 inches (88 cm) for women; (b) fasting blood glucose \>100mg/dL and \<126mg/dL or hemoglobin A1C 5.7-6.4 %.

You may not qualify if:

• anticipated inability to complete study protocol for any reason;
• current eating disorder;
• use of insulin, glucose-sensitizing medication, vasoactive medication (including glucocorticoids, antineoplastic agents, psychoactive agents, or bronchodilators) or nutraceuticals;
• regular use of fiber supplements;
• diabetes;
• sleep apnea;
• restricted diets by choice (e.g., vegetarian, vegan);
• coagulopathy, known bleeding diathesis, or history of clinically significant hemorrhage, or current use of warfarin;
• regular exercise as defined by participating in moderate-intensity \> 150 minutes/week.

Sponsors & Collaborators

• Griffin Hospital: lead

Study Sites (1)

Yale-Griffin Prevention Research Center

Derby, Connecticut, 06418, United States

Location

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PRINCIPAL INVESTIGATOR

Model Details: To provide a sound basis for the statistical comparison of outcome measures for treatment assignments, participants will be randomized to 1 of 2 sequence permutations of extra virgin olive oil enriched meal and refined olive oil enriched meal. Each permutation will include a first treatment assignment, followed by a 1-week washout phase, and followed by a second treatment assignment.

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 18, 2019
• Study Start: July 9, 2019
• Primary Completion: August 22, 2019
• Study Completion: August 22, 2019
• Last Updated: March 30, 2020

Record last verified: 2020-03

Locations

US (1)