NCT01684332

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 12, 2012

Completed
Last Updated

September 19, 2012

Status Verified

September 1, 2012

Enrollment Period

3 months

First QC Date

September 10, 2012

Last Update Submit

September 18, 2012

Conditions

PostprandialHyperglycemia, PostprandialFeeding BehaviorsAntioxidantLipid Profile

Keywords

Antioxidantglucose metabolismjampolyphenolspostprandialstrawberry

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (9)

  • Serum glucose postprandial concentration

    Baseline, 30, 60, 90 and 120 minutes

  • Serum insulin postprandial concentration

    baseline, 30, 60, 90 and 120 minutes

  • HOMA insulin resistance index

    Baseline, 30, 60, 90 and 120 minutes

  • Serum total cholesterol postprandial concentration

    Baseline, 30, 60, 90 and 120 minutes

  • Serum HDL-cholesterol postprandial concentration

    Baseline, 30, 60, 90 and 120 minutes

  • +4 more secondary outcomes

Study Arms (3)

High Sugar (HS)

EXPERIMENTAL

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

Other: Strawberry Jam

Low Sugar (LS)

EXPERIMENTAL

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

Other: Strawberry Jam

Low Sugar + Antioxidant (LSA)

EXPERIMENTAL

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

Interventions

Strawberry JamOTHER
High Sugar (HS)Low Sugar (LS)Low Sugar + Antioxidant (LSA)

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adult men and women
  • Normal weight or overweight (BMI between 18.5 and 29.9 kg/m2)
  • Age between 20 and 50 years old.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nutrition, Food Science and Physiology

Pamplona, Navarre, 31008, Spain

Location

Related Publications (1)

  • 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.

    PMID: 23553051DERIVED

Related Links

MeSH Terms

Conditions

HyperglycemiaFeeding Behavior

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBehavior, AnimalBehavior

Study Officials

  • J. Alfredo Martínez, PhD

    University of Navarra

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Nutrition and Food Science

Study Record Dates

First Submitted

September 10, 2012

First Posted

September 12, 2012

Study Start

September 1, 2010

Primary Completion

December 1, 2010

Study Completion

March 1, 2011

Last Updated

September 19, 2012

Record last verified: 2012-09

Locations

ES(1)