PostprandialNCT01684332
Postprandial Response to Different Jams
A study testing Strawberry Jam in people with Postprandial and Hyperglycemia, Postprandial, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial, Hyperglycemia, Postprandial, Feeding Behaviors
- What is being tested?
- Strawberry Jam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2010to Mar 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult men and women
- Normal weight or overweight (BMI between 18.5 and 29.9 kg/m2)
- Age between 20 and 50 years old.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Department of Nutrition, Food Science and Physiology
Pamplona, Navarre, 31008
About this study
Official title: 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.
Read the 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).
- Being tested
- Strawberry Jam
- Keywords
- Antioxidant, glucose metabolism, jam, polyphenols, postprandial, strawberry
- Medical subject headings
- Hyperglycemia, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strawberry JamOther
| Study group | Role | What they receive |
|---|---|---|
| High Sugar (HS) | Experimental | Study of the postprandial effects after consuming 60g of strawberry jam with high sugar content Receives: Other: Strawberry Jam |
| Low Sugar (LS) | Experimental | Study of the postprandial effects after consuming 60g of strawberry jam with low sugar content Receives: 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 Receives: Other: Strawberry Jam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 120 minutes
Secondary outcomes (9)
Serum glucose postprandial concentration
Serum Glucose measured at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam
Measured: Baseline, 30, 60, 90 and 120 minutes
Serum insulin postprandial concentration
Serum insulin measured at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam
Measured: baseline, 30, 60, 90 and 120 minutes
HOMA insulin resistance index
HOMA-IR calculated at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam
Measured: Baseline, 30, 60, 90 and 120 minutes
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
Measured: Baseline, 30, 60, 90 and 120 minutes
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
Measured: Baseline, 30, 60, 90 and 120 minutes
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
Measured: Baseline, 30, 60, 90 and 120 minutes
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
Measured: Baseline, 30, 60, 90 and 120 minutes
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
Measured: Baseline, 30, 60, 90 and 120 minutes
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
Measured: Baseline, 30, 60, 90 and 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2012 (estimated)
- Study startSep 2010
- Primary completionDec 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PostprandialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfredo Martinez, Clinica Universidad de Navarra, Universidad de Navarra
- Investigators
- J. Alfredo Martínez, PhD, Principal investigator, University of NavarraM. Ángeles Zulet, PhD, Study chair, University of NavarraMarta Cuervo, PhD, Study chair, University of NavarraSantiago Navas-Carretero, PhD, Study chair, University of NavarraIdoia Ibero-Baraibar, MsC, Study chair, University of Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01684332
- Sponsor's protocol ID
- UNAV-078-2010
- Status last verified
- Sep 2012
- First submitted
- 10 Sep 2012
- Last updated
- 19 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23553051
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effects of Three Strawberry Jams, Differing in Carbohydrate and Antioxidant Content, on Postprandial Response in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01684332
- Acronym / sponsor ID
- UNAV-078-2010
- Keywords
- Antioxidant, glucose metabolism, jam, polyphenols, postprandial, strawberry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 12 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Sugar (HS) | Experimental | Other: Strawberry JamStudy of the postprandial effects after consuming 60g of strawberry jam with high sugar content |
| Low Sugar (LS) | Experimental | Other: Strawberry JamStudy of the postprandial effects after consuming 60g of strawberry jam with low sugar content |
| Low Sugar + Antioxidant (LSA) | Experimental | Other: Strawberry JamStudy of the postprandial effects after consuming 60g of strawberry jam with low sugar content and an antioxidant extract from strawberry pulp |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult men and women
- Normal weight or overweight (BMI between 18.5 and 29.9 kg/m2)
- Age between 20 and 50 years old.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strawberry Jam | Other | High Sugar (HS), Low Sugar (LS), Low Sugar + Antioxidant (LSA) |
Primary outcome
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
9 secondary outcomes
Serum glucose postprandial concentration
Time frame: Baseline, 30, 60, 90 and 120 minutes
Serum insulin postprandial concentration
Time frame: baseline, 30, 60, 90 and 120 minutes
HOMA insulin resistance index
Time frame: Baseline, 30, 60, 90 and 120 minutes
Serum total cholesterol postprandial concentration
Time frame: Baseline, 30, 60, 90 and 120 minutes
Serum HDL-cholesterol postprandial concentration
Time frame: Baseline, 30, 60, 90 and 120 minutes
Serum LDL-cholesterol postprandial concentration
Time frame: Baseline, 30, 60, 90 and 120 minutes
Serum Uric Acid postprandial concentration
Time frame: Baseline, 30, 60, 90 and 120 minutes
Plasma Glutathione Peroxidase postprandial activity
Time frame: Baseline, 30, 60, 90 and 120 minutes
Postprandial Plasma Total Antioxidant Capacity
Time frame: Baseline, 30, 60, 90 and 120 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2012.
- Derived from this study: PubMed 23553051Ibero-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.
- University of NavarraLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. Alfredo Martínez, PhD principal investigator
University of Navarra
M. Ángeles Zulet, PhD study chair
University of Navarra
Marta Cuervo, PhD study chair
University of Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strawberry Jam in people with Postprandial and Hyperglycemia, Postprandial, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma malondialdehyde (MDA) postprandial measure (time frame: up to 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01684332, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2012.