Condition category
Not Applicable
Date applied
17/02/2016
Date assigned
19/02/2016
Last edited
18/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The amount of sugar (glucose) in the blood is controlled by a hormone called insulin. If you have diabetes, either the body does not produce enough insulin or the insulin produced doesn't work properly, leading to high blood glucose levels. Extracts of the Salacia species of herb from roots, stems, and leaves are used for the treatment of diabetes in Asia. The aim of this study is to examine the effect of different doses of a new form of Salacia extract (Salacia Chinensis, SCE) on the glucose and insulin response to oral sucrose (sugar) solution in healthy individuals (South Asian Population).

Who can participate?
People aged 18-55, with body mass index (BMI) 24.5 to 29.5 kg/m2

What does the study involve?
Participants are given sucrose solution and Salacia extract, and blood samples are collected at the start and after 30, 60, 90, 120 and 180 minutes to assess their blood glucose and insulin response. Different doses of Salacia extract are tested with a 7-day break in between treatments and results are compared with a placebo (dummy) treatment.

What are the possible benefits and risks of participating?
We will find out whether Salacia supplementation helps to maintain or lower blood glucose and insulin levels after sucrose solution administration. This will help them to understand how to manage blood glucose levels and helps in diabetes condition. Pain associated due to multiple times of blood collection to assess blood glucose and insulin levels.

Where is the study run from?
Semler Research Center (India)

When is the study starting and how long is it expected to run for?
July to December 2015

Who is funding the study?
Atlantic Canada Opportunities Agency

Who is the main contact?
Dr Vijaya Juturu

Trial website

Contact information

Type

Scientific

Primary contact

Dr Vijaya Juturu

ORCID ID

http://orcid.org/0000-0002-7397-715X

Contact details

OmniActive Health Technologies Inc.
67 East Park Place
Suite 500
Morristown
07960
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

OAHT_SE2015

Study information

Scientific title

Salacia extract improves post-prandial glucose and insulin response: a randomized double-blind placebo-controlled, cross-over study in healthy volunteers

Acronym

Study hypothesis

Studies indicate that Salacia extracts modulate multiple targets that influence carbohydrate and lipid metabolism. This study is to examine the effect of differing doses of a novel form of Salacia extract (Salacia Chinensis, SCE) on glucose and insulin response to an oral sucrose load in healthy individuals (South Asian Population).

Ethics approval

Sri Venkateswara Hospital Ethics Committee , India, 08/06/2015, ref: S-15-1203

Study design

Randomized double-blind placebo-controlled cross-over study

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Not Applicable

Intervention

Participants will be randomly assigned to ingest Salacia extract at dosages of 200 mg SCE , 300 mg SCE and 500 mg SCE (OmniLeanTM) or placebo (PLA) in a single-center, double-blind, randomized, placebo-controlled four-way cross-over design. Washout period between treatment periods was 7 days. Plasma glucose and plasma insulin responses after 0, 30, 60, 90, 120, 180 min of ingesting oral sucrose standard solution and area under curve for glucose (AUCglucose) and insulin response (AUCinsulin) will be calculated. ANOVA and paired t-tests will be used to examine differences between treatments and over baseline.

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

Glucose and insulin responses after 0, 30, 60, 90, 120 and 180 min

Secondary outcome measures

AUC glucose and AUC insulin

Overall trial start date

30/07/2015

Overall trial end date

30/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male and female subjects aged 18-55 years of age (both ages inclusive), of BMI 24.5 to 29.5 Kg/ m2
2. Participants required to avoid all dietary supplements, OTC or any foods interfere with post-prandial glucose and insulin before and throughout the study period and not allowed to drink alcoholic beverages or caffeine during the period of the study
3. Non smokers
4. No pregnant and lactating women
5. Signed consent form

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Participation in any bioavailability/bioequivalence/pharmacokinetic study or received an investigational drug within a period of 3 calendar months prior to check in of period one
2. Use of dietary supplements to reduce body weight or metabolic health management at least 30 days before check in of period one
3. Use of hormone replacement therapy for a period of 6 calendar months prior to check in of period one
4. History of drug abuse, or alcohol dependence or abuse
5. History of any allergies (asthma, urticaria) including drug allergies
6. Known hypersensitivity or allergy to Salacia extract or any of the excipients or related drugs.
7. Smokers, prescriptions, chronic conditions such as hypertension, diabetes , inflammatory disorders, cardiovascular disease and cancer etc

Recruitment start date

02/08/2015

Recruitment end date

08/09/2015

Locations

Countries of recruitment

India

Trial participating centre

Semler Research Center
Semler Research Center Pvt. Ltd P A Arcade, No 21, 22, 23 Kodigehalli Main Road Sahakarnagar
Bangalore
560092
India

Sponsor information

Organisation

OmniActive Health Technologies Ltd (Canada)

Sponsor details

c/o Dr Jayant Deshpande
Omni Active Health Technologies (Canada) Limited
Bio commons Research Park in Charlottetown
Prince Edward Island
C1A 8R8
Canada

Sponsor type

Industry

Website

Funders

Funder type

Government

Funder name

Atlantic Canada Opportunities Agency

Alternative name(s)

Agence de Promotion Économique du Canada Atlantique, ACOA

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Canada

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

30/08/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes