Effects of Added D-fagomine on Glycaemic Responses to Sucrose

Bioglane

Status: Completed

Conditions: Reduction of Post-prandial Glycaemic Response

Treatments: Other: D-fagomine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01811303

RSSL SSID P12-06545

Details and patient eligibility

About

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

Full description

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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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14 participants in 2 patient groups, including a placebo group

D-fagomine

Experimental group

Description:

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

Treatment:

Other: D-fagomine

Control

Placebo Comparator group

Description:

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

Treatment:

Other: D-fagomine