NCT02352857

Brief Summary

The study aims to evaluate the glycaemic and insulinaemic response of short-chain fructo-oligosaccharides (scFOS) used to replace sugars (e.g. dextrose) in foods.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2013

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

October 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
1 year until next milestone

First Posted

Study publicly available on registry

February 2, 2015

Completed
Last Updated

February 2, 2015

Status Verified

January 1, 2015

Enrollment Period

4 months

First QC Date

November 25, 2013

Last Update Submit

January 28, 2015

Conditions

Glycaemia

Keywords

Fructo-oligosaccharidesSugar-reduced foodsPostprandial glucose response

Outcome Measures

Primary Outcomes (1)

  • Glycaemic response

    Blood glucose kinetics with 7 points. Analysis of the Area under the curve of glucose.

    2 hours and 5 minutes

Secondary Outcomes (5)

  • Insulinaemic response

    2 hours and 5 minutes

  • Blood glucose peak (Cmax)

    One-time data (the highest one) within the 2hrs 5mins kinetics.

  • Blood insulin peak (Cmax)

    One-time data (the highest one) within the 2hrs 5mins kinetics.

  • Glucose Tmax : time to reach the peak of blood glucose

    One time within the 2hrs 5mins kinetics.

  • Insulin Tmax : time to reach the peak of blood insulin

    One time within the 2hrs 5mins kinetics.

Study Arms (2)

Sugar

PLACEBO COMPARATOR

Control group consuming sponge cakes containing in total 24g of dextrose.

Other: Sugar

FOS

EXPERIMENTAL

Group consuming sponge cakes in which 30% of the dextrose was replaced by FOS.

Other: FOS

Interventions

SugarOTHER

100g of sponge cakes made with 24g of dextrose.

Sugar
FOSOTHER

100g of sponge cakes made with 19.4g of dextrose and 9.1g of FOS.

FOS

Eligibility Criteria

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

You may qualify if:

  • Body mass index (BMI) between 18.0 and 25.0 kg/m² (included);
  • Ready to keep the same volume of physical activity and the same dietary habits during the study and particularly 24 hours before each visit;
  • Be used to have breakfast;
  • Non-smoker for at least 3 months;
  • For the female participant: not being pregnant or breastfeeding and using efficient birth control;
  • Signed the consent form;
  • Able to follow the instructions of the study;
  • Health insured;
  • Accepted to be included in the National Registry for biomedical research Volunteers (Fichier VRB, Volontaires Recherches Biomédicales).

You may not qualify if:

  • Fasting blood glucose over 6.1 mmol/L (1.10 g/L) (or diabetes treated or not);
  • Fasting blood cholesterol over 6.35 mmol/L;
  • Fasting blood triglycerides over 1.70 mmol/L (or history of insulinoma);
  • Fasting blood insulin under 20 mU/L;
  • Fasting HbA1c under 7%;
  • History of hypercholesterolemia, hypertension, diabetes or glucose intolerance treated or not;
  • History of dietary allergies or coeliac disease;
  • History of digestive system disease susceptible to modify digestion or absorption like Crohn's disease;
  • Somatic or psychiatric disorders;
  • Renal insufficiency (kidney failure);
  • SGOT or ALAT over 52.5 U/L;
  • Smoker;
  • Consuming more than 3 alcoholic beverage a day;
  • Weight varied 3 kg the last 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NutrInvest - Institut Pasteur de Lille

Lille, Nord, 59019, France

Location

MeSH Terms

Interventions

Sugars

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

  • Jean-Michel LECERF, MD

    Institut Pasteur de Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Endocrinologist, Nutritionist

Study Record Dates

First Submitted

November 25, 2013

First Posted

February 2, 2015

Study Start

October 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

February 2, 2015

Record last verified: 2015-01

Locations

FR(1)