Healthy AdultsLIPSNCT01240837
Effect of Palm Sugar on Blood Glucose Concentrations
A study testing Arenga Pinnata Sugar, Glucose and Sucrose in people with Healthy Adults, run by Wageningen University at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine by how much, the ingestion of palm sugar increases blood glucose concentrations and what the corresponding glycaemic index is. The investigators estimate that the glycaemic index will be 68 (equal to that of sucrose). Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- Arenga Pinnata Sugar, Glucose and Sucrose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2010to Jan 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy: as judged by the participant;
- Age: 18 to 35.
Who cannot join
- Pregnant or lactating females
- Presence of a chronic disease such as diabetes, illness, dysmetabolic syndrome
- 18.5 < BMI < 25
- Allergy or intolerance to palms or coconuts
- Weight loss or gain of more then 5 kg in the last two months
- Fasting blood glucose levels <100 mg/dl or 5.6 mmol/l
Show all 9Show fewer
- Smokers
- Use of medications other then birth control
- Previous problems with blood sampling
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Glycaemic Index of Arenga Pinnata Palm Sugar
The purpose of this study is to determine by how much, the ingestion of palm sugar increases blood glucose concentrations and what the corresponding glycaemic index is. The investigators estimate that the glycaemic index will be 68 (equal to that of sucrose).
- Conditions
- Healthy Adults
- Being tested
- Arenga Pinnata Sugar, Glucose, Sucrose
- Keywords
- glycaemic index, arenga pinnata sugar, palm sugar, diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arenga Pinnata SugarOther
Also called palm sugar
50 g palm sugar given orally 1 time in 250 ml of water. Blood glucose measurements will then be taken at time points, 0, 15, 30, 45, 60, 90 and 120 minutes.
GlucoseOther
50 g glucose given orally 3 time in 250 ml of water. Blood glucose measurements will then be taken at time points, 0, 15, 30, 45, 60, 90 and 120 minutes.
SucroseOther
Also called sugar, table sugar
50 g sucrose given orally 1 time in 250 ml of water. Blood glucose measurements will then be taken at time points, 0, 15, 30, 45, 60, 90 and 120 minutes.
| Study group | Role | What they receive |
|---|---|---|
| glucose | Active comparator | Not described Receives: Other: Glucose |
| sucrose | Active comparator | Not described Receives: Other: Sucrose |
| palm sugar | Experimental | Not described Receives: Other: Arenga Pinnata Sugar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose concentrations
During the labratory visits subjects will ingest glucose (control), sucrose or palm sugar. At time points 0, 15, 30, 45, 60, 90 and 120 minutes post ingestion blood glucose concentrations will be measured by finger prick blood samples.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lydia Afman, Dr, Principal investigator, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01240837
- Sponsor's protocol ID
- 33657
- Acronym
- LIPS
- Status last verified
- Mar 2012
- First submitted
- 11 Nov 2010
- Last updated
- 12 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Glycaemic Index of Arenga Pinnata Palm Sugar
- ClinicalTrials.gov ID
- NCT01240837
- Acronym / sponsor ID
- LIPS / 33657
- Conditions
- Healthy Adults
- Keywords
- glycaemic index, arenga pinnata sugar, palm sugar, diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 15 Nov 2010 (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 purpose of this study is to determine by how much, the ingestion of palm sugar increases blood glucose concentrations and what the corresponding glycaemic index is. The investigators estimate that the glycaemic index will be 68 (equal to that of sucrose).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| glucose | Active comparator | Other: Glucose |
| sucrose | Active comparator | Other: Sucrose |
| palm sugar | Experimental | Other: Arenga Pinnata Sugar |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy: as judged by the participant;
- Age: 18 to 35.
Key exclusion criteria (9 listed)
- Pregnant or lactating females
- Presence of a chronic disease such as diabetes, illness, dysmetabolic syndrome
- 18.5 < BMI < 25
- Allergy or intolerance to palms or coconuts
- Weight loss or gain of more then 5 kg in the last two months
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 |
|---|---|---|
| Arenga Pinnata SugarAlso: palm sugar50 g palm sugar given orally 1 time in 250 ml of water. Blood glucose measurements will then be taken at time points, 0, 15, 30, 45, 60, 90 and 120 minutes. | Other | palm sugar |
| Glucose50 g glucose given orally 3 time in 250 ml of water. Blood glucose measurements will then be taken at time points, 0, 15, 30, 45, 60, 90 and 120 minutes. | Other | glucose |
| SucroseAlso: sugar, table sugar50 g sucrose given orally 1 time in 250 ml of water. Blood glucose measurements will then be taken at time points, 0, 15, 30, 45, 60, 90 and 120 minutes. | Other | sucrose |
Primary outcome
Blood glucose concentrations
Time frame: 2 months
During the labratory visits subjects will ingest glucose (control), sucrose or palm sugar. At time points 0, 15, 30, 45, 60, 90 and 120 minutes post ingestion blood glucose concentrations will be measured by finger prick blood samples.
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 12 Mar 2012.
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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.
Lydia Afman, Dr principal investigator
Wageningen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arenga Pinnata Sugar, Glucose and Sucrose in people with Healthy Adults, run by Wageningen University at 1 site in Netherlands.
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 2 inclusion and 9 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 12 Mar 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 Netherlands. 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?
Blood glucose concentrations (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2012.