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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01684332
Other study ID # UNAV-078-2010
Secondary ID
Status Completed
Phase N/A
First received September 10, 2012
Last updated September 18, 2012
Start date September 2010
Est. completion date March 2011

Study information

Verified date September 2012
Source Clinica Universidad de Navarra, Universidad de Navarra
Contact n/a
Is FDA regulated No
Health authority Spain: Comité Ético de Investigación Clínica
Study type Interventional

Clinical Trial Summary

The aim of this study is to investigate the effects of an acute intake of three different types of strawberry jam, differing in the carbohydrates and antioxidants content, on postprandial glucose metabolism, lipid profile, antioxidant status and satiety indices, in healthy adults.


Description:

Study Design: Randomized, postprandial, crossover, double-blind intervention with three arms.

Subjects: Sixteen healthy adults

Product studied: At each arm, participants consume 60g of strawberry jam:

- High-sugar jam (traditional; HS),

- Low-sugar jam (without added-sugar; LS),

- Low-sugar jam including antioxidant extract from strawberry pulp (LSA).


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date March 2011
Est. primary completion date December 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Adult men and women

- Normal weight or overweight (BMI between 18.5 and 29.9 kg/m2)

- Age between 20 and 50 years old.

Exclusion Criteria:

- To suffer from any chronic disease related to metabolism,

- To follow concomitant medications,

- To follow slimming treatments or hormone replacement therapy,

- To have any inability to perform the follow-up,

- Smoking,

- Known food allergies,

- Pregnancy, lactation or menopause

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention


Intervention

Other:
Strawberry Jam


Locations

Country Name City State
Spain Department of Nutrition, Food Science and Physiology Pamplona Navarra

Sponsors (1)

Lead Sponsor Collaborator
Clinica Universidad de Navarra, Universidad de Navarra

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Plasma malondialdehyde (MDA) postprandial measure Plasma MDA measured at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam up to 120 minutes No
Secondary Serum glucose postprandial concentration Serum Glucose measured at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam Baseline, 30, 60, 90 and 120 minutes No
Secondary Serum insulin postprandial concentration Serum insulin measured at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam baseline, 30, 60, 90 and 120 minutes No
Secondary HOMA insulin resistance index HOMA-IR calculated at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam Baseline, 30, 60, 90 and 120 minutes No
Secondary Serum total cholesterol postprandial concentration Serum total cholesterol measured at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam Baseline, 30, 60, 90 and 120 minutes No
Secondary Serum HDL-cholesterol postprandial concentration Serum HDL-cholesterol measured at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam Baseline, 30, 60, 90 and 120 minutes No
Secondary Serum LDL-cholesterol postprandial concentration Serum LDL-cholesterol calculated at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam Baseline, 30, 60, 90 and 120 minutes No
Secondary Serum Uric Acid postprandial concentration Serum Uric Acid measured at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam Baseline, 30, 60, 90 and 120 minutes No
Secondary Plasma Glutathione Peroxidase postprandial activity Plasma Glutathione Peroxidase activity measured at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam Baseline, 30, 60, 90 and 120 minutes No
Secondary Postprandial Plasma Total Antioxidant Capacity Plasma Total Antioxidant capacity measured at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam Baseline, 30, 60, 90 and 120 minutes No
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