NCT01811303

Brief Summary

The purpose of this study is to determine whether D-fagomine affects glycaemic responses to sucrose (commercial white sugar)and quantify the response

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2012

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

September 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 14, 2013

Completed
4 months until next milestone

Results Posted

Study results publicly available

July 2, 2013

Completed
Last Updated

September 18, 2023

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

March 12, 2013

Results QC Date

April 3, 2013

Last Update Submit

August 25, 2023

Conditions

Reduction of Post-prandial Glycaemic Response

Outcome Measures

Primary Outcomes (1)

  • Postprandial Glycaemic Response Index

    On each intervention, the volunteer measured a baseline fasting blood sugar measurement for that day and repeated this approximately 5 minutes later so that two fasting measurements were obtained under the supervision of staff. All of the subsequent measurements were assessed against the average of the two baseline readings. Each subject was then presented with a test product and they were instructed to consume the whole amount within a fifteen-minute period. Each volunteer then took a blood sugar readings at 15, 30, 45, 60, 90 and 120 minutes following the initiation of consumption of the test product. Measurements were taken using the Ascensia Contour, Blood Glucose Monitoring Systems (Bayer), which analysed the blood sample and provided a blood glucose reading in mmol/l. The AUC is calculated using the trapezoid rule and the final outcome is the incremental area under the curve for the arm expressed as a percent of the average response for the control by the same subject.

    120 minutes

Secondary Outcomes (1)

  • Maximum Blood Glucose Concentration (C Max) Over the Baseline

    Usually in the range of 30-45 minutes

Study Arms (2)

D-fagomine

EXPERIMENTAL

Measure the changes produced on the postprandial Glycaemic response to 50 g of sucrose containing 40 mg D-fagomine, in 200 ml water

Other: D-fagomine

Control

PLACEBO COMPARATOR

Sucrose 50 g without d-fagomine, in 200 ml water

Other: D-fagomine

Interventions

D-fagomineOTHER

Measure the changes produced on the postprandial Glycaemic response

ControlD-fagomine

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female (not less than 40% Male)
  • Aged 18 - 55 years
  • Have a body mass index between 18.5 to 29.99 kg/m2
  • Healthy, non-diabetic, no gastric bypass surgery
  • Have a fasting plasma glucose (finger-stick) \<100 mg/dl (\<5.5 mmol/L)
  • Willing and able to provide written informed consent

You may not qualify if:

  • Smokers
  • Allergic to dairy or soy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reading Scientific Services Ltd.

Reading, RG6 6LA, United Kingdom

Location

Related Publications (2)

  • Gomez L, Molinar-Toribio E, Calvo-Torras MA, Adelantado C, Juan ME, Planas JM, Canas X, Lozano C, Pumarola S, Clapes P, Torres JL. D-Fagomine lowers postprandial blood glucose and modulates bacterial adhesion. Br J Nutr. 2012 Jun;107(12):1739-46. doi: 10.1017/S0007114511005009. Epub 2011 Oct 3.

    PMID: 22017795BACKGROUND

  • Amezqueta S, Galan E, Vila-Fernandez I, Pumarola S, Carrascal M, Abian J, Ribas-Barba L, Serra-Majem L, Torres JL. The presence of D-fagomine in the human diet from buckwheat-based foodstuffs. Food Chem. 2013 Feb 15;136(3-4):1316-21. doi: 10.1016/j.foodchem.2012.09.038. Epub 2012 Sep 18.

    PMID: 23194529BACKGROUND

MeSH Terms

Interventions

fagomine

Results Point of Contact

Title
Rungano Munyuki (Clinical Project Manager)
Organization
RSSL
0118 9184034

Study Officials

  • Rungano Munyuki

    Reading Scientific Services Ltd.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

March 12, 2013

First Posted

March 14, 2013

Study Start

September 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

September 18, 2023

Results First Posted

July 2, 2013

Record last verified: 2023-08

Locations

GB(1)