Postprandial Response to Different Jams

September 18, 2012 updated by: Alfredo Martinez, Clinica Universidad de Navarra, Universidad de Navarra

Study of the Effects of Three Strawberry Jams, Differing in Carbohydrate and Antioxidant Content, on Postprandial Response in Healthy Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Department of Nutrition, Food Science and Physiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High Sugar (HS)
Study of the postprandial effects after consuming 60g of strawberry jam with high sugar content
Other: Strawberry Jam
Experimental: Low Sugar (LS)
Study of the postprandial effects after consuming 60g of strawberry jam with low sugar content
Other: Strawberry Jam
Experimental: Low Sugar + Antioxidant (LSA)
Study of the postprandial effects after consuming 60g of strawberry jam with low sugar content and an antioxidant extract from strawberry pulp
Other: Strawberry Jam

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma malondialdehyde (MDA) postprandial measure
Time Frame: up to 120 minutes
Plasma MDA measured at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam
up to 120 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum glucose postprandial concentration
Time Frame: Baseline, 30, 60, 90 and 120 minutes
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
Serum insulin postprandial concentration
Time Frame: baseline, 30, 60, 90 and 120 minutes
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
HOMA insulin resistance index
Time Frame: Baseline, 30, 60, 90 and 120 minutes
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
Serum total cholesterol postprandial concentration
Time Frame: Baseline, 30, 60, 90 and 120 minutes
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
Serum HDL-cholesterol postprandial concentration
Time Frame: Baseline, 30, 60, 90 and 120 minutes
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
Serum LDL-cholesterol postprandial concentration
Time Frame: Baseline, 30, 60, 90 and 120 minutes
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
Serum Uric Acid postprandial concentration
Time Frame: Baseline, 30, 60, 90 and 120 minutes
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
Plasma Glutathione Peroxidase postprandial activity
Time Frame: Baseline, 30, 60, 90 and 120 minutes
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
Postprandial Plasma Total Antioxidant Capacity
Time Frame: Baseline, 30, 60, 90 and 120 minutes
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Investigators

  • Principal Investigator: J. Alfredo Martínez, PhD, University of Navarra
  • Study Chair: Marta Cuervo, PhD, University of Navarra
  • Study Chair: Idoia Ibero-Baraibar, MsC, University of Navarra

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

September 10, 2012

First Submitted That Met QC Criteria

September 11, 2012

First Posted (Estimate)

September 12, 2012

Study Record Updates

Last Update Posted (Estimate)

September 19, 2012

Last Update Submitted That Met QC Criteria

September 18, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNAV-078-2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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