NCT01240837

Brief 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 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

November 1, 2010

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 15, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

March 12, 2012

Status Verified

March 1, 2012

Enrollment Period

2 months

First QC Date

November 11, 2010

Last Update Submit

March 9, 2012

Conditions

Healthy Adults

Keywords

glycaemic indexarenga pinnata sugarpalm sugardiabetes

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 months

Study Arms (3)

glucose

ACTIVE COMPARATOR
Other: Glucose

sucrose

ACTIVE COMPARATOR
Other: Sucrose

palm sugar

EXPERIMENTAL
Other: Arenga Pinnata Sugar

Interventions

Arenga Pinnata SugarOTHER

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.

Also known as: palm sugar
palm sugar
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.

glucose
SucroseOTHER

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.

Also known as: sugar, table sugar
sucrose

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy: as judged by the participant;
  • Age: 18 to 35.

You may not qualify if:

  • Pregnant or lactating females
  • Presence of a chronic disease such as diabetes, illness, dysmetabolic syndrome
  • \< 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
  • Smokers
  • Use of medications other then birth control
  • Previous problems with blood sampling

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wageningen University

Wageningen, Gelderland, 6701 BH, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

GurGlucoseSucroseSugarsDietary Sucrose

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesCarbohydratesDisaccharidesOligosaccharidesPolysaccharidesDietary SugarsDietary CarbohydratesNutritive SweetenersSweetening AgentsFlavoring AgentsFood AdditivesFood IngredientsSpecialty Uses of ChemicalsChemical Actions and UsesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Lydia Afman, Dr

    Wageningen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2010

First Posted

November 15, 2010

Study Start

November 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

March 12, 2012

Record last verified: 2012-03

Locations

NL(1)