The Effects of Strawberries on Blood Cholesterol.

Nevada System of Higher Education (NSHE) logo

Nevada System of Higher Education (NSHE)

Status

Completed

Conditions

Hyper-LDL-cholesterolemia
Metabolic Syndrome

Treatments

Dietary Supplement: strawberries
Other: Control powder

Study type

Interventional

Funder types

Other

Identifiers

NCT03441620
1119274

Details and patient eligibility

About

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.

Full description

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, 9, and 14 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]. 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. Screening and follow-up tests will include clinical laboratory tests for blood glucose, lipids, NMR profiles, C-reactive protein and metabolic panel to determine effects of the intervention.

Enrollment

33 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • elevated total and LDL cholesterol (>116 mg/dL)
  • body mass index (> or = 30 kg/m2)
  • features of the metabolic syndrome

Exclusion criteria

  • taking glucose and lipid lowering medications (e.g. statins, metformin)
  • history of chronic conditions (diabetes, CHD, anemia, renal diseases)
  • allergic to strawberries
  • pregnant and/or lactating
  • smoking
  • vegetarian or consuming special diet

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

33 participants in 3 patient groups, including a placebo group

Control
Placebo Comparator group
Description:
Calorie and fiber-matched control powder
Treatment:
Other: Control powder
Strawberry one serving
Experimental group
Description:
Freeze-dried powder equivalent to one serving fresh strawberries per day.
Treatment:
Dietary Supplement: strawberries
Strawberry two-half servings
Experimental group
Description:
Freeze-dried powder equivalent to 2.5 serving fresh strawberries per day.
Treatment:
Dietary Supplement: strawberries

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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