Salacia extract improves post-prandial glucose and insulin response
| ISRCTN | ISRCTN84979645 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84979645 |
| Secondary identifying numbers | OAHT_SE2015 |
- Submission date
- 17/02/2016
- Registration date
- 19/02/2016
- Last edited
- 31/07/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
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
Contact information
Scientific
OmniActive Health Technologies Inc.
67 East Park Place, Suite 500
Morristown
07960
United States of America
 ORCID ID |
0000-0002-7397-715X |
|---|
Study information
| Study design | Randomized double-blind placebo-controlled cross-over study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Salacia extract improves post-prandial glucose and insulin response: a randomized double-blind placebo-controlled, cross-over study in healthy volunteers |
| 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(s) | Sri Venkateswara Hospital Ethics Committee , India, 08/06/2015, ref: S-15-1203 |
| 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 |
| Primary outcome measure | Glucose and insulin responses after 0, 30, 60, 90, 120 and 180 min |
| Secondary outcome measures | AUC glucose and AUC insulin |
| Overall study start date | 30/07/2015 |
| Overall study end date | 30/12/2015 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 55 Years |
| Sex | Both |
| Target number of participants | 40 |
| 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 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
Study participating centre
P A Arcade, No 21, 22, 23
Kodigehalli Main Road
Sahakarnagar
Bangalore
560092
India
Sponsor information
Industry
c/o Dr Jayant Deshpande
OmniActive Health Technologies (Canada) Limited
Bio commons Research Park in Charlottetown
Prince Edward Island
C1A 8R8
Canada
"ROR" |
https://ror.org/05rga6m50 |
|---|
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Agence de Promotion Économique du Canada Atlantique, ACOA Canada, ACOA
- Location
- Canada
Results and Publications
| Intention to publish date | 30/08/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | To be confirmed at a later date |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2016 | Yes | No |
Editorial Notes
31/07/2018: Publication reference added.
