NCT01680211

Brief Summary

Objective of this study is to determine the safety and efficacy of administration of herbal supplements (Salacia leaf extract, Salacia root extract and Sesame seed extract) for 6 weeks in the management of prediabetes and mild to moderate hyperlipidemia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 7, 2012

Completed
Last Updated

September 7, 2012

Status Verified

September 1, 2012

Enrollment Period

2 months

First QC Date

August 29, 2012

Last Update Submit

September 3, 2012

Conditions

PrediabetesHyperlipidemia

Keywords

Blood Sugar,Lipoproteins,Salacia,Sesame,Prediabetes,Hyperlipidemia,Herbal supplement

Outcome Measures

Primary Outcomes (1)

  • Change in Blood Sugar and lipid profiles

    Change in of blood sugar out come will be measured by Fasting Blood Sugar (FBS), Oral Glucose Tolerance Test (OGTT) and Postprandial Blood Sugar (PPBS). Change in lipid profiles are measured by Low Density Lipoprotein (LDL), Very Low Density Lipoprotein (VLDL), High Density Lipoprotein (HDL) and Total Cholesterol (TC).

    baseline and 6 weeks

Secondary Outcomes (1)

  • Clinical laboratory evaluations

    0 and week 6

Study Arms (4)

Salacia bark extract (SR-B-01) and TLC

EXPERIMENTAL

Capsules containing 250mg of salacia bark extract,two times a day along with Therapeutic Lifestyle Change (TLC)

Dietary Supplement: Salacia bark extractBehavioral: TLC

Sesame seeds extract (SI-S-01) and TLC

EXPERIMENTAL

Capsules containing 250mg of sesame seed extract,two times a day along with Therapeutic Lifestyle Change (TLC)

Dietary Supplement: Sesame seed extractBehavioral: TLC

Salacia leaf extract (SR-L-01) and TLC

EXPERIMENTAL

Capsules containing 250mg of salacia leaf extract,two times a day along with Therapeutic Lifestyle Change (TLC)

Dietary Supplement: Salacia leaf extractBehavioral: TLC

Placebo and TLC

PLACEBO COMPARATOR

Capsules containing 250mg of placebo,two times a day along with Therapeutic Lifestyle Change (TLC)

Behavioral: TLCOther: Placebo

Interventions

Salacia bark extractDIETARY_SUPPLEMENT
Salacia bark extract (SR-B-01) and TLC
Salacia leaf extractDIETARY_SUPPLEMENT
Salacia leaf extract (SR-L-01) and TLC
Sesame seed extractDIETARY_SUPPLEMENT
Sesame seeds extract (SI-S-01) and TLC
TLCBEHAVIORAL

Lifestyle changes include diet, exercise, weight loss, etc.

Placebo and TLCSalacia bark extract (SR-B-01) and TLCSalacia leaf extract (SR-L-01) and TLCSesame seeds extract (SI-S-01) and TLC
PlaceboOTHER
Placebo and TLC

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • As per ATP III guidelines: Baseline LDL ranging 160-189 mg/dL, TC \>200 mg/dL and with no or one of the below risk factors
  • Current cigarette smoking
  • Family history of premature Coronary Heart Disease(CHD); in male first degree relative \<55 years; in female first degree relative \<65 years)
  • Hypertension (BP \>140/90 mmHg or on antihypertensive medication)
  • Low HDL-C (\<40 mg/dL)
  • Age (men \> 40 years)
  • Impaired glucose tolerance (2-hour post 75 g OGTT glucose levels in the range of ≥140 to ≤ 200 mg/dL)
  • Impaired fasting sugar (Fasting blood sugar levels in the range of ≥ 100 to ≤125 mg/dL)
  • Being mentally competent and able to understand all study requirements and sign the informed consent form.

You may not qualify if:

  • Patients with severe liver, renal, cardiac or brain diseases.
  • Pregnant or lactating women or women of child bearing potential whom are not practicing a reliable form of birth control (either with IUD or with stable usage of oral contraceptives).
  • Unable to complete follow up.
  • Subjects on any medication that would affect evaluation like Statins.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Srinivasa Clinic & Diabetic Care Center

Bangalore, Karnataka, 560050, India

Location

MeSH Terms

Conditions

Prediabetic StateHyperlipidemiasSeSAME syndrome

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDyslipidemiasLipid Metabolism Disorders

Study Officials

  • K R Raveendra, M.D

    Srinivasa Clinic & Diabetic Care Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2012

First Posted

September 7, 2012

Study Start

April 1, 2012

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

September 7, 2012

Record last verified: 2012-09

Locations

IN(1)