The effect of Amlamax (made from Indian gooseberry) on raising good cholesterol.

A Pilot Clinical Study to Evaluate the Potential of AMLAMAX (trademark (TM)) (Emblica Officinalis) Extract on Raising HDL-Cholesterol levels and Decreasing Plasma Amyloid beta Levels in subjective memory complainers with low HDL-C.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000432910

Enrollment

167

Registered

2011-04-27

Start date

2011-05-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Several evidence support the notion that increase in total plasma cholesterol, low-density lipoprotein-cholesterol (LDLC), and decreased high-density lipoprotein-cholesterol (HDL-C) are risk factors for cardiovascular disease (CVD). Epidemiological studies have reported that high concentrations of HDL-C or "good" cholesterol (>1.5mMol/L) may also be protective against Alzheimer’s disease (AD). “AmlamaxTM” developed by the R&D lab of Arjuna Natural Extracts Limited (Kerala, India) is a dry extract from fresh fruits of Amla, which has shown remarkable results in increasing HDL-C levels. Therefore, the objectives of this proposed study will be to explore the effectiveness of the herbal extract AmlamaxTM on raising HDL cholesterol levels in population of subjects with low HDL-C levels drawn from the Perth memory cohort study, as well as to determine whether directly raising HDL-C levels can result in a decrease in plasma beta amyloid levels.

Interventions

Nutritional therapy using a standardised amla extract from Indian gooseberry in raising HDL-C i.e. good cholesterol and decreasing beta amyloid, the main protein involved in the pathogenesis of Alzheimer's Disease. Duration: A randomized double-blind-placebo-control study for a period of 6 months. Mode of administration: oral administration. Dose: Ingestion of 2 x 500 mg AmlamaxTM capsules /Placebo (1g/day total).

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

35 Years to 65 Years

Healthy volunteers

Inclusion criteria

Inclusion Criteria: The eligibility criteria will be as follows: 1) age 35-65 years, 2) HDL-C levels <1.03 mMol/L in men or <1.29 mMol/L in women 3) triglyceride (TG) levels >1.7 mMol/L. psychometric testing using standardized, validated diagnostic tools. Mini-Mental State Examination (MMSE) score greater than or equal to 24. 2. The classification of SMC will be obtained from a single question, yes/no response from the CAMDEX-R (Do you have any difficulty with your memory? 2.A score greater than or equal to 80-81 (CAMCOG)-R (cognitive component of the CAMDEX-R). 4. a score of below, equal and above age and education norms on the California Verbal Learning Test (CVLT).

Exclusion criteria

Patients suffering from heart failure, chronic liver disease, eGFR<60 ml/min.

Outcome results