The Effects of Strawberries on Blood Cholesterol.
Status: | Recruiting |
---|---|
Conditions: | High Cholesterol, Endocrine |
Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 2/24/2018 |
Start Date: | February 1, 2018 |
End Date: | December 31, 2019 |
Contact: | Arpita Basu, PHD |
Email: | arpita.basu@unlv.edu |
Phone: | 7028954576 |
Effects of Strawberries on LDL Cholesterol and Insulin Resistance in Overweight/Obese Adults With the Metabolic Syndrome.
In this study, we propose to investigate the effects of dietary achievable doses of
strawberries on serum LDL-cholesterol (LDL-C) and related lipid profiles, measures of
glycemia and insulin resistance, and biomarkers of inflammation in a 14 week controlled
crossover study.
strawberries on serum LDL-cholesterol (LDL-C) and related lipid profiles, measures of
glycemia and insulin resistance, and biomarkers of inflammation in a 14 week controlled
crossover study.
Screening and consenting: Any interested participant will be screened via a telephone call,
and based on this information, participants will then be scheduled for the screening visit,
consented and enrolled in the study. The screen forms have been attached to the protocol. For
those who do not qualify, screen forms will be immediately destroyed. The screen visit will
involve an 8 hour fasting state and the following procedures:
- Completing screening questionnaire
- Measuring height, weight, blood pressure, and waist size
- Drawing about 30mL blood for blood glucose and lipids and comprehensive metabolic panel
All subjects will be asked to follow usual diet and lifestyle, and refrain from other
sources of berries and related products while on the study. Subjects will also maintain
3-day food records at screen, 4, 8, and 12 weeks of the study. Height, weight, blood
pressure and waist circumference will be measured by trained personnel at MPE 326 (KNS
facility for clinical research). Blood draws will be performed by trained phlebotomists
(to be hired) at MPE 326, and all procedures will be performed by trained research
personnel [PI &Co-PI: Basu, Izuora and graduate student (to be hired)]. In case of blood
pressure, an average of at least three readings, 10 min apart, will be measured at each
visit for each participant. Blood glucose (fasting and postprandial at two hours) will
be determined at each time point. The oral glucose tolerance tests will be conducted at
MPE 326 and blood samples will be sent to Quest Diagnostics, Las Vegas. Insulin
resistance will be calculated using the homoeostatic model assessment (HOMA-IR). The
HOMA-IR is a standard and widely used formula in calculating insulin resistance based on
fasting glucose values. These values will be calculated using a Microsoft excel
spreadsheet for each participant. Screening tests will include clinical laboratory tests
for blood glucose, lipids, C-reactive protein and metabolic panel to determine
eligibility in the study
and based on this information, participants will then be scheduled for the screening visit,
consented and enrolled in the study. The screen forms have been attached to the protocol. For
those who do not qualify, screen forms will be immediately destroyed. The screen visit will
involve an 8 hour fasting state and the following procedures:
- Completing screening questionnaire
- Measuring height, weight, blood pressure, and waist size
- Drawing about 30mL blood for blood glucose and lipids and comprehensive metabolic panel
All subjects will be asked to follow usual diet and lifestyle, and refrain from other
sources of berries and related products while on the study. Subjects will also maintain
3-day food records at screen, 4, 8, and 12 weeks of the study. Height, weight, blood
pressure and waist circumference will be measured by trained personnel at MPE 326 (KNS
facility for clinical research). Blood draws will be performed by trained phlebotomists
(to be hired) at MPE 326, and all procedures will be performed by trained research
personnel [PI &Co-PI: Basu, Izuora and graduate student (to be hired)]. In case of blood
pressure, an average of at least three readings, 10 min apart, will be measured at each
visit for each participant. Blood glucose (fasting and postprandial at two hours) will
be determined at each time point. The oral glucose tolerance tests will be conducted at
MPE 326 and blood samples will be sent to Quest Diagnostics, Las Vegas. Insulin
resistance will be calculated using the homoeostatic model assessment (HOMA-IR). The
HOMA-IR is a standard and widely used formula in calculating insulin resistance based on
fasting glucose values. These values will be calculated using a Microsoft excel
spreadsheet for each participant. Screening tests will include clinical laboratory tests
for blood glucose, lipids, C-reactive protein and metabolic panel to determine
eligibility in the study
Inclusion Criteria:
- elevated total and LDL cholesterol
- features of the metabolic syndrome
Exclusion Criteria:
- previous history of adverse CVD events
- allergic to strawberries
- pregnant and/or lactating
We found this trial at
2
sites
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1100 North Lindsay Avenue
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73104
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