Effects of Added D-fagomine on Glycaemic Responses to Sucrose

• Sponsor: Bioglane (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01811303
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arms: 2
• Duration (Months): 5.9
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Reduction of Post-prandial Glycaemic Response	Other: D-fagomine	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: Effects of Added D-fagomine on Glycaemic Responses to Sucrose
• Study Start Date: Sep 1, 2012
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Other: D-fagomine; Measure the changes produced on the postprandial Glycaemic response to 50 g of sucrose in 200 ml water if added 40 mg D-fagomine
Placebo Comparator: Control Sucrose 50 g without d-fagomine, in 200 ml water

Outcome Measures

Primary Outcome Measures

1. Postprandial Glycaemic Response Index [120 minutes]

   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.

Secondary Outcome Measures

1. Maximum Blood Glucose Concentration (C Max) Over the Baseline [Usually in the range of 30-45 minutes]

   Determine the glucose C max of Sucrose with D-fagomine over the baseline. The blood glucose maximum concentration (C-Max) expressed in mmol/L of the average response for a 50g sucrose, over the baseline. Calculation of the outcome is= (Measure glucose C-Max - Measure glucose baseline)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Reading Scientific Services Ltd.	Reading		United Kingdom	RG6 6LA

Sponsors and Collaborators

• Bioglane

Investigators

• Principal Investigator: Rungano Munyuki, Reading Scientific Services Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Amézqueta S, Galán E, Vila-Fernández 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.
• Gómez L, Molinar-Toribio E, Calvo-Torras MÁ, Adelantado C, Juan ME, Planas JM, Cañas X, Lozano C, Pumarola S, Clapés 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.

• Responsible Party: Bioglane
• ClinicalTrials.gov Identifier: NCT01811303
• Other Study ID Numbers: RSSL SSID P12-06545
• First Posted: Mar 14, 2013
• Last Update Posted: Jul 2, 2013
• Last Verified: Apr 1, 2013

Study Results

Participant Flow

Recruitment Details	Recruitment of adults volunteers done by RSSL, in Reading (United Kingdom), under GCP.
Pre-assignment Detail	There was 15 subjects screened that all were complying with the eligibility criteria. Finally only 14 subjects were involved in the study and analysed as far the study was planned to involve 12 subjects. All 14 subjects received the treatment randomized to a William's Latin square design balanced for treatment order.

Arm/Group Title	Placebo, Placebo, Treatment, Treatment	Treatment, Treatment, Placebo, Placebo	Placebo, Treatment, Placebo, Treatment	Treatment, Placebo, Treatment, Placebo
Arm/Group Description	The subjects receive placebo in the first two interventions.	The subjects receive treatment in the first two interventions	The subjects receive placebo or treatment in each intervention alternatively, starting with placebo.	The subjects receive placebo or treatment in each intervention alternatively, starting with treatment.
Period Title: First Intervention (1 Day)
STARTED	4	4	4	2
COMPLETED	4	4	4	2
NOT COMPLETED	0	0	0	0
Period Title: First Intervention (1 Day)
STARTED	4	4	4	2
COMPLETED	4	4	4	2
NOT COMPLETED	0	0	0	0
Period Title: First Intervention (1 Day)
STARTED	4	4	4	2
COMPLETED	4	4	4	2
NOT COMPLETED	0	0	0	0
Period Title: First Intervention (1 Day)
STARTED	4	4	4	2
COMPLETED	4	4	4	2
NOT COMPLETED	0	0	0	0
Period Title: First Intervention (1 Day)
STARTED	4	4	4	2
COMPLETED	4	4	4	2
NOT COMPLETED	0	0	0	0
Period Title: First Intervention (1 Day)
STARTED	4	4	4	2
COMPLETED	4	4	4	2
NOT COMPLETED	0	0	0	0
Period Title: First Intervention (1 Day)
STARTED	4	4	4	2
COMPLETED	4	4	4	2
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	D-fagomine (All Study Participants)
Arm/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 vs placebo.
Overall Participants	14
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	14 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39.8 (11.2)
Sex: Female, Male (Count of Participants)
Female	8 57.1%
Male	6 42.9%
Region of Enrollment (participants) [Number]
United Kingdom	14 100%

Outcome Measures

1. Primary Outcome

Title	Postprandial Glycaemic Response Index
Description	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.
Time Frame	120 minutes

Outcome Measure Data

Analysis Population Description

The number of participants >10, the repetitions >= 2 and also other variables was determined based on F. Brouns et al., Glycaemic index methodology,Nutrition Research Reviews (2005), 18, 145-171. Also was considered the advice and previous GI studies from RSSL based on master protocol GIMST09.

Arm/Group Title	Change D-fagomine/Control AUC at 60 Min	Change D-fagomine/Control AUC at 120 Min
Arm/Group Description	Determine the relative change in the Glycaemic response between sucrose with D-fagomine and sucrose without D-fagomine in the first 60 minutes (postprandial). Calculated on incremental Area Under the Curve (AUC) from the individual glucose measurements in capillary blood, and evaluated by repeated measures ANOVA.	Determine the relative change in the Glycaemic response between sucrose with D-fagomine and sucrose without D-fagomine in the first 120 minutes (postprandial). Calculated on incremental Area Under the Curve (AUC) from the individual glucose measurements in capillary blood, and evaluated by repeated measures ANOVA.
Measure Participants	14	14
Mean (95% Confidence Interval) [percentage of AUC fagomine/AUC control]	73.28	83.45

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Change D-fagomine/Control AUC at 60 Min
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Change D-fagomine/Control AUC at 120 Min
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.016
	Comments
	Method	ANOVA
	Comments

2. Secondary Outcome

Title	Maximum Blood Glucose Concentration (C Max) Over the Baseline
Description	Determine the glucose C max of Sucrose with D-fagomine over the baseline. The blood glucose maximum concentration (C-Max) expressed in mmol/L of the average response for a 50g sucrose, over the baseline. Calculation of the outcome is= (Measure glucose C-Max - Measure glucose baseline)
Time Frame	Usually in the range of 30-45 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	D-fagomine	Control
Arm/Group Description	Determination of glucose Cmax over the Baseline of the treatment: sucrose 50 g + 200 ml water + 40 mg D-fagomine. Blood glucose concentration expressed in mmol/l.	Determination of glucose Cmax over the Baseline of the control: sucrose 50 g + 200 ml water. Blood glucose concentration expressed in mmol/l.
Measure Participants	14	14
Mean (Standard Error) [mmol/L]	2.3 (0.19)	3.6 (0.37)

Adverse Events

Arm/Group Title	D-fagomine (All Study Participants)		Placebo - Control (All Study Participants)
Arm/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.		Measure the changes produced on the postprandial Glycaemic response to 50 g sucrose in 200 ml water (without d-fagomine)
All Cause Mortality
	D-fagomine (All Study Participants)		Placebo - Control (All Study Participants)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	D-fagomine (All Study Participants)		Placebo - Control (All Study Participants)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/14 (0%)
Other (Not Including Serious) Adverse Events
	D-fagomine (All Study Participants)		Placebo - Control (All Study Participants)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/14 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.