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Postprandial Response to Different Jams

Primary Purpose

Postprandial, Hyperglycemia, Postprandial, Feeding Behaviors

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Strawberry Jam
Sponsored by
Clinica Universidad de Navarra, Universidad de Navarra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postprandial focused on measuring Antioxidant, glucose metabolism, jam, polyphenols, postprandial, strawberry

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Nutrition, Food Science and Physiology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

High Sugar (HS)

Low Sugar (LS)

Low Sugar + Antioxidant (LSA)

Arm Description

Study of the postprandial effects after consuming 60g of strawberry jam with high sugar content

Study of the postprandial effects after consuming 60g of strawberry jam with low sugar content

Study of the postprandial effects after consuming 60g of strawberry jam with low sugar content and an antioxidant extract from strawberry pulp

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Serum glucose postprandial concentration
Serum Glucose measured at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam
Serum insulin postprandial concentration
Serum insulin measured at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam
HOMA insulin resistance index
HOMA-IR calculated at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam
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
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
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
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
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
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

Full Information

First Posted
September 10, 2012
Last Updated
September 18, 2012
Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
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1. Study Identification

Unique Protocol Identification Number
NCT01684332
Brief Title
Postprandial Response to Different Jams
Official Title
Study of the Effects of Three Strawberry Jams, Differing in Carbohydrate and Antioxidant Content, on Postprandial Response in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinica Universidad de Navarra, Universidad de Navarra

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postprandial, Hyperglycemia, Postprandial, Feeding Behaviors, Antioxidant, Lipid Profile
Keywords
Antioxidant, glucose metabolism, jam, polyphenols, postprandial, strawberry

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Sugar (HS)
Arm Type
Experimental
Arm Description
Study of the postprandial effects after consuming 60g of strawberry jam with high sugar content
Arm Title
Low Sugar (LS)
Arm Type
Experimental
Arm Description
Study of the postprandial effects after consuming 60g of strawberry jam with low sugar content
Arm Title
Low Sugar + Antioxidant (LSA)
Arm Type
Experimental
Arm Description
Study of the postprandial effects after consuming 60g of strawberry jam with low sugar content and an antioxidant extract from strawberry pulp
Intervention Type
Other
Intervention Name(s)
Strawberry Jam
Primary Outcome Measure Information:
Title
Plasma malondialdehyde (MDA) postprandial measure
Description
Plasma MDA measured at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam
Time Frame
up to 120 minutes
Secondary Outcome Measure Information:
Title
Serum glucose postprandial concentration
Description
Serum Glucose measured at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam
Time Frame
Baseline, 30, 60, 90 and 120 minutes
Title
Serum insulin postprandial concentration
Description
Serum insulin measured at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam
Time Frame
baseline, 30, 60, 90 and 120 minutes
Title
HOMA insulin resistance index
Description
HOMA-IR calculated at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam
Time Frame
Baseline, 30, 60, 90 and 120 minutes
Title
Serum total cholesterol postprandial concentration
Description
Serum total cholesterol measured at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam
Time Frame
Baseline, 30, 60, 90 and 120 minutes
Title
Serum HDL-cholesterol postprandial concentration
Description
Serum HDL-cholesterol measured at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam
Time Frame
Baseline, 30, 60, 90 and 120 minutes
Title
Serum LDL-cholesterol postprandial concentration
Description
Serum LDL-cholesterol calculated at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam
Time Frame
Baseline, 30, 60, 90 and 120 minutes
Title
Serum Uric Acid postprandial concentration
Description
Serum Uric Acid measured at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam
Time Frame
Baseline, 30, 60, 90 and 120 minutes
Title
Plasma Glutathione Peroxidase postprandial activity
Description
Plasma Glutathione Peroxidase activity measured at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam
Time Frame
Baseline, 30, 60, 90 and 120 minutes
Title
Postprandial Plasma Total Antioxidant Capacity
Description
Plasma Total Antioxidant capacity measured at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam
Time Frame
Baseline, 30, 60, 90 and 120 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. Alfredo Martínez, PhD
Organizational Affiliation
University of Navarra
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
M. Ángeles Zulet, PhD
Organizational Affiliation
University of Navarra
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Marta Cuervo, PhD
Organizational Affiliation
University of Navarra
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Santiago Navas-Carretero, PhD
Organizational Affiliation
University of Navarra
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Idoia Ibero-Baraibar, MsC
Organizational Affiliation
University of Navarra
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Nutrition, Food Science and Physiology
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
23553051
Citation
Ibero-Baraibar I, Cuervo M, Navas-Carretero S, Abete I, Zulet MA, Martinez JA. Different postprandial acute response in healthy subjects to three strawberry jams varying in carbohydrate and antioxidant content: a randomized, crossover trial. Eur J Nutr. 2014 Feb;53(1):201-10. doi: 10.1007/s00394-013-0517-7. Epub 2013 Apr 4.
Results Reference
derived
Links:
URL
http://www.unav.es
Description
University of Navarra

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Postprandial Response to Different Jams

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