Effects of Added D-fagomine on Glycaemic Responses to Sucrose

NCT ID: NCT01811303

Last Updated: 2023-09-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-03-31

Brief Summary

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

Detailed Description

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This is a two treatment randomized double-blind crossover study, with each test product replicated twice.

Randomization: Subjects will be randomized to a Williams Latin square design balanced for treatment order.

Washout: 2 days or more (may return on day 3)

Run-in: High carbohydrate diet guidance (\>150 g/d) 1 day before treatment, recommend same sized dinner the previous night (no food record collection required)

Drop-outs: Subjects who have dropped out before visit 2 will be replaced by another subject randomized in their place (the new subject will complete all treatments)

Subjects will report after an overnight (12 hour) fast for baseline sample collection, and will consume the test product in a fasted state.

Conditions

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Reduction of Post-prandial Glycaemic Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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D-fagomine

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

Group Type EXPERIMENTAL

D-fagomine

Intervention Type OTHER

Measure the changes produced on the postprandial Glycaemic response

Control

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

Group Type PLACEBO_COMPARATOR

D-fagomine

Intervention Type OTHER

Measure the changes produced on the postprandial Glycaemic response

Interventions

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D-fagomine

Measure the changes produced on the postprandial Glycaemic response

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Smokers
* Allergic to dairy or soy
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bioglane

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rungano Munyuki

Role: PRINCIPAL_INVESTIGATOR

Reading Scientific Services Ltd.

Locations

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Reading Scientific Services Ltd.

Reading, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 22017795 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23194529 (View on PubMed)

Other Identifiers

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RSSL SSID P12-06545

Identifier Type: -

Identifier Source: org_study_id

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