NCT01343797

Brief Summary

The aim of the study is to determine glycemic and insulinemic index of 2 sweet syrups : FructiLight® and fruit Fructo-oligosaccharides in sweet matrix compared to glucose.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Feb 2011

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2011

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 28, 2011

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

April 28, 2011

Status Verified

April 1, 2011

Enrollment Period

28 days

First QC Date

April 20, 2011

Last Update Submit

April 27, 2011

Conditions

Healthy

Keywords

Glycemic indexInsulinemic indexFructo-oligosaccharide syrupFructose syrupAged between eighteen and fifty years oldBMI between nineteen and twenty five kg/m²Non diabetic or pre-diabeticWithout liver, renal or gastro-intestinal disorderNon-smoker

Outcome Measures

Primary Outcomes (1)

  • Area Under the glycemia Curve over 120 min (AUC 0-120min)

    Syrup glycemic response compare to glucose glycemic response. Measure with glucometer at time 15, 30, 45, 60, 90, 120 (and 180 minutes) after the intake of 50g of glucose equivalent from the products (syrup or glucose). AUC(0-120min) calculation is computed following the FAO recommendation (cf. FAO/WHO 1998), i.e. using the trapezoidal incremental method and not taking into account the area beneath the fasting concentration.

    120 minutes after intake by test

Secondary Outcomes (1)

  • Area Under the insulinemia Curve over 120 min (AUC 0-120min)

    120 minutes after intake by test

Interventions

Glycemic and insulinemic index tests of a fruit fructose syrup and a fruit fructo-oligosaccharid syrupOTHER

One test with 65,5g of fruit (apple) extract sugar syrup with high fructose content in 250mL of water One test with 108,2g of peach purified sugar syrup with high fructo-oligosaccharid content in 250mL of water Three tests with the reference : 50g of anhydrous glucose in 250mL of water

Eligibility Criteria

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

You may qualify if:

  • Aged between 18 to 50 years (limits included
  • With a BMI between 19 and 25 kg/m² (limits included)
  • Non-smoker
  • Non-menopausal female with reliable contraception for two cycles before the beginning of the study and agreeing to keep it during the entire duration of the study
  • Capable and willing to conform to the protocol and accepting to give his written informed consent
  • Registered to Social Security System
  • Accepting to be registered on the Volunteers in biomedical research file
  • After biological analysis, the subjects will be included on the following criteria :
  • Fasting blood sugar level \< 1,1 g/L
  • Blood sugar level 120 minutes after 75g glucose intake \< 1.4 g/L
  • Complete blood count without significant clinically abnormality according to the investigator
  • ASAT \< 1,55 µkat/L
  • ALAT \< 1,7 µkat/L
  • GGT \< 2,55 µkat/L
  • \< Creatinine \< 104 µmol/L
  • +1 more criteria

You may not qualify if:

  • Known food allergy, in particular to one of the tested products' components or to related products
  • Personal history of hypercholesterolemia, high blood pressure, diabetes or glucose intolerance
  • Renal insufficiency
  • Liver disorders ongoing
  • Gastrointestinal disorders, clinically significant according the investigator
  • Use of medications which could affect lipidic or carbohydrate metabolism
  • Disease or medication with impact on nutrients digestion and absorption
  • Pregnant or breastfeeding women
  • General anaesthetic in the month before the study
  • Presenting a psychological or linguistic incapability to sign the informed consent
  • Refusing to sign the informed consent
  • Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision
  • Having received, during the last 12 months, indemnities for clinical trial higher or equal to 4500 Euros
  • Impossible to contact in case of emergency
  • Major or medical or surgical event with hospitalization in the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biofortis

Nantes, Pays de la Loire Region, 44000, France

Location

MeSH Terms

Conditions

Glucose IntoleranceDigestive System Diseases

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 20, 2011

First Posted

April 28, 2011

Study Start

February 1, 2011

Primary Completion

March 1, 2011

Study Completion

May 1, 2011

Last Updated

April 28, 2011

Record last verified: 2011-04

Locations

FR(1)