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Postprandial Response to Different Jams

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ClinicalTrials.gov Identifier: NCT01684332
Recruitment Status : Completed
First Posted : September 12, 2012
Last Update Posted : September 19, 2012
Sponsor:
Information provided by (Responsible Party):
Alfredo Martinez, Clinica Universidad de Navarra, Universidad de Navarra

Brief 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.

Condition or disease Intervention/treatment Phase
Postprandial Hyperglycemia, Postprandial Feeding Behaviors Antioxidant Lipid Profile Other: Strawberry Jam Not Applicable

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  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Study of the Effects of Three Strawberry Jams, Differing in Carbohydrate and Antioxidant Content, on Postprandial Response in Healthy Subjects
Study Start Date : September 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antioxidants
U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01684332


Locations
Spain
Department of Nutrition, Food Science and Physiology
Pamplona, Navarra, Spain, 31008
Sponsors and Collaborators
Clinica Universidad de Navarra, Universidad de Navarra
Investigators
Principal Investigator: J. Alfredo Martínez, PhD University of Navarra
Study Chair: M. Ángeles Zulet, PhD University of Navarra
Study Chair: Marta Cuervo, PhD University of Navarra
Study Chair: Santiago Navas-Carretero, PhD University of Navarra
Study Chair: Idoia Ibero-Baraibar, MsC University of Navarra

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alfredo Martinez, Professor of Nutrition and Food Science, Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier: NCT01684332     History of Changes
Other Study ID Numbers: UNAV-078-2010
First Posted: September 12, 2012    Key Record Dates
Last Update Posted: September 19, 2012
Last Verified: September 2012

Keywords provided by Alfredo Martinez, Clinica Universidad de Navarra, Universidad de Navarra:
Antioxidant
glucose metabolism
jam
polyphenols
postprandial
strawberry

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs