Safety and Efficacy Study of Herbal Supplements in Prediabetic and Mild to Moderate Hyperlipidemic Patients

Olive Lifesciences

Status: Completed

Conditions: Prediabetes; Hyperlipidemia

Treatments: Other: Placebo; Dietary Supplement: Sesame seed extract; Dietary Supplement: Salacia leaf extract; Dietary Supplement: Salacia bark extract; Behavioral: TLC

Study type: Interventional

Funder types: Industry

Identifiers

NCT01680211

OL-S-OB-LP/03-12

CTRI/2012/05/002678 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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)

2. Impaired glucose tolerance (2-hour post 75 g OGTT glucose levels in the range of ≥140 to ≤ 200 mg/dL)

3. Impaired fasting sugar (Fasting blood sugar levels in the range of ≥ 100 to ≤125 mg/dL)

4. Being mentally competent and able to understand all study requirements and sign the informed consent form.

Exclusion criteria

1. Patients with severe liver, renal, cardiac or brain diseases.
2. 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).
3. Unable to complete follow up.
4. Subjects on any medication that would affect evaluation like Statins.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 4 patient groups, including a placebo group

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

Experimental group

Description:

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

Treatment:

Dietary Supplement: Salacia bark extract

Behavioral: TLC

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

Experimental group

Description:

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

Treatment:

Dietary Supplement: Sesame seed extract

Behavioral: TLC

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

Experimental group

Description:

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

Treatment:

Dietary Supplement: Salacia leaf extract

Behavioral: TLC

Placebo and TLC

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo

Behavioral: TLC