The Effects of Strawberries on Blood Cholesterol.

• Sponsor: University of Nevada, Las Vegas (Other)
• Overall Status: Completed
• CT.gov ID: NCT03441620
• Collaborator: University of Oklahoma (Other), Oklahoma State University (Other)
• Enrollment: 33
• Locations: 3
• Arms: 3
• Actual Duration (Months): 36
• Patients Per Site: 11
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hyper-LDL-cholesterolemia; Metabolic Syndrome	Dietary Supplement: strawberries; Other: Control powder	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Effects of Strawberries on LDL Cholesterol and Insulin Resistance in Overweight/Obese Adults With the Metabolic Syndrome.
• Actual Study Start Date: Feb 1, 2018
• Actual Primary Completion Date: Jan 31, 2021
• Actual Study Completion Date: Jan 31, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Serum Lipid profiles [14 weeks]

   Serum LDL, total and HDL cholesterol, triglycerides

2. Glycemic control [14 weeks]

   Blood glucose

3. Serum lipid particle concentrations [14 weeks]

   Molar concentrations of serum lipids and particle size

4. Diabetes control [14 weeks]

   Insulin resistance

Secondary Outcome Measures

1. Systemic Inflammation [14 weeks]

   Serum C-reactive protein and adipokines

2. Systemic Anthocyanins [14 weeks]

   Strawberry anthocyanin metabolites measured in serum

3. Serum metabolomics [14 weeks]

   primary and lipid metabolites in serum

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Nevada at Las Vegas	Las Vegas	Nevada	United States	89154
2	University of Oklahoma Health Sciences Center, OCTSI	Oklahoma City	Oklahoma	United States	73104
3	Oklahoma State University	Stillwater	Oklahoma	United States	74078

Sponsors and Collaborators

• University of Nevada, Las Vegas
• University of Oklahoma
• Oklahoma State University

Investigators

• Principal Investigator: Arpita Basu, PHD, University of Nevada at Las Vegas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Arpita Basu, Associate Professor, University of Nevada, Las Vegas
• ClinicalTrials.gov Identifier: NCT03441620
• Other Study ID Numbers: 1119274
• First Posted: Feb 22, 2018
• Last Update Posted: Mar 16, 2021
• Last Verified: Mar 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Metabolic Syndrome; Syndrome

Study Results

No Results Posted as of Mar 16, 2021