Raspberries and Human Health - Full Text View

Sponsors and Collaborators:	University of Toronto St. Michael's Hospital, Toronto
Information provided by:	University of Toronto
ClinicalTrials.gov Identifier:	NCT00876811

Purpose

The purpose of this study is determine whether daily consumption of frozen red raspberries can improve the antioxidant capacity of the blood and reduce the effects of oxidative stress, dose-dependently, in a healthy adult population.

Condition	Intervention	Phase
Oxidative Stress Inflammation Diabetes Mellitus Cardiovascular Diseases Obesity Cancer	Dietary Supplement: individually quick frozen red raspberries	Phase I

MedlinePlus related topics: Antioxidants Diabetes Dietary Supplements Diets Obesity

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Pharmacokinetics/Dynamics Study
Official Title:	Raspberries and Human Health

Further study details as provided by University of Toronto:

Primary Outcome Measures:

oxidative damage to low-density lipoprotein (LDL) measured as thiobarbituric acid-reactive substances in the LDL fraction of serum from fasting blood samples [ Time Frame: end of study week 0, 1, 3, 5 and 9 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

hsCRP concentration in serum from fasting blood samples [ Time Frame: end of study week 0, 1, 3, 5 and 9 ] [ Designated as safety issue: No ]
Trolox Equivalent Antioxidant Capacity (TEAC)measured in serum from fasting blood samples, expressed in Trolox Equivalents [ Time Frame: end of study week 0, 1, 3, 5, 9 ] [ Designated as safety issue: No ]
Protein thiol oxidation will be measured with DTNB using serum from fasting blood samples. [ Time Frame: end of study week 0, 1, 3, 5 and 9 ] [ Designated as safety issue: No ]
8-oxodG levels will be measured by HPLC as an indication of DNA oxidation in isolated DNA from fasting blood samples. [ Time Frame: end of study week 0, 1, 3, 5 and 9 ] [ Designated as safety issue: No ]
Catalase (CAT) activity will be measured in hemolysates from fasting blood samples [ Time Frame: end of study week 0, 1, 3, 5 and 9 ] [ Designated as safety issue: No ]
Glutathione peroxidase (GSH-Px) activity will be measured in hemolysates from fasting blood samples. [ Time Frame: end of study week 0, 1, 3, 5 and 9 ] [ Designated as safety issue: No ]
Superoxide Dismutase (SOD) activity is measured in colorless hemolysates from fasting blood samples [ Time Frame: end of study week 0, 1, 3, 5 and 9 ] [ Designated as safety issue: No ]
ellagic acid concentrations will be measured by HPLC in the fasting blood samples and 12 hr urine collections [ Time Frame: end of study week 0, 1, 3, 5 and 9 ] [ Designated as safety issue: No ]
fasting blood glucose levels [ Time Frame: end of study week 0, 1, 3, 5 and 9 ] [ Designated as safety issue: No ]

Enrollment:	24
Study Start Date:	March 2009
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
one-cup: Experimental	Dietary Supplement: individually quick frozen red raspberries Consumption of one-cup frozen red raspberries daily for four weeks, followed by a four week period of non-treatment.
two-cups: Experimental	Dietary Supplement: individually quick frozen red raspberries Consumption of one-cup frozen red raspberries for two weeks, then consumption of two-cups frozen red raspberries for an additional two weeks, followed by four weeks of non-treatment.
four-cups: Experimental	Dietary Supplement: individually quick frozen red raspberries Consumption of one-cup frozen red raspberries for two weeks, then consumption of four-cups frozen red raspberries for an addition two weeks, followed by four weeks of non-treatment.

Detailed Description:

Red raspberries are an excellent source of numerous polyphenolic antioxidants. The bioactivity of these compounds have been implicated in many biological pathways and may function to reduce the risk of numerous chronic diseases. We are conducting an intervention study with frozen red raspberries on a healthy adult population in order to determine if raspberry polyphenols are bioavailable and bioactive in vivo. Twenty-four subjects (12 male and 12 female) will be recruited to participate and consume one-cup frozen red raspberries daily for two weeks, they then will randomly be assigned to consume either one, two or four cups of raspberries for another two weeks, this will be followed by four weeks of non-treatment. Blood samples and 12-hour urine collections will be taken in order to measure the concentration of raspberry polyphenols in response to treatment dose. Dose-dependent treatment effects on blood biomarkers for antioxidant capacity, oxidative stress, inflammation and other chronic disease risk factors will also be measured.

Eligibility

Ages Eligible for Study:	18 Years to 43 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

healthy adults

Exclusion Criteria:

obese (>30kg/m2)
high blood pressure (140/90mmHg)
allergic to raspberries
pregnant or lactating
history of chronic disease
currently taking medication

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00876811

Locations

Canada, Ontario
Risk Factor Modification Centre, St. Michael's Hospital
Toronto, Ontario, Canada, M5C 2T2

Sponsors and Collaborators

University of Toronto

St. Michael's Hospital, Toronto

Investigators

Principal Investigator:

A. Venket Rao, M.Sc., Ph.D.

Department of Nutritional Sciences, University of Toronto

More Information

No publications provided

Responsible Party:	Department of Nutritional Sciences, Faculty of Medicine, University of Toronto ( Dr. A. V. Rao, M.Sc., Ph.D., Professor Emeritus )
Study ID Numbers:	22069
Study First Received:	April 3, 2009
Last Updated:	April 3, 2009
ClinicalTrials.gov Identifier:	NCT00876811 History of Changes
Health Authority:	Canada: Ethics Review Committee

Keywords provided by University of Toronto:

raspberry
berry
fruit
ellagic acid

antioxidant
oxidative stress
inflammation
dietary intervention

Study placed in the following topic categories:

Obesity
Antioxidants
Metabolic Diseases
Diabetes Mellitus
Stress
Endocrine System Diseases
Overweight
Inflammation

Body Weight
Signs and Symptoms
Nutrition Disorders
Overnutrition
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Obesity
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Overweight
Inflammation
Body Weight

Signs and Symptoms
Pathologic Processes
Nutrition Disorders
Cardiovascular Diseases
Overnutrition
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009