JOURNAL OF MEDICINAL FOOD
J Med Food 16 (6) 2013, 564–568# Mary Ann Liebert, Inc., and Korean Society of Food Science and Nutrition
DOI: 10.1089/jmf.2013.2751

SHORT COMMUNICATION

Salacia reticulata Improves Serum Lipid Profiles and Glycemic Control
in Patients with Prediabetes and Mild to Moderate Hyperlipidemia:
A Double-Blind, Placebo-Controlled, Randomized Trial

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H.N. Shivaprasad,1 M. Bhanumathy,1 G. Sushma,1 T. Midhun,1 K.R. Raveendra,2K.R. Sushma,2 and K. Venkateshwarlu 2
Research and Development Centre, Olive Lifesciences Pvt. Ltd., Sahakar Nagar, Bengaluru, India.
2Srinivasa Clinic and Diabetic Care Centre, Girinagar, Bengaluru, India.

ABSTRACT The present randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of Salacia
reticulata leaves and root bark extracts in 29 patients with prediabetes and mild to moderate hyperlipidemia. Patients
received either Salacia extracts (500 mg/day) or placebo along with therapeutic lifestyle changes for a period of 6 weeks.
Efficacy was evaluated in terms of change in lipid profile and glycemic levels. The safety and tolerability was evaluated bya physical examination and clinical laboratory evaluations. Improvements in lipid profiles and glycemic levels wereobserved in Salacia extract-treated groups when compared to placebo at week 6. A statistical significant reduction wasobserved in low-density lipoprotein cholesterol and fasting blood sugar (FBS) levels at week 3 and 6 when treated with root
bark extract. The leaves extract-treated group showed statistically significant reduction in FBS levels at week 6 only. No
adverse events occurred and all safety parameters were within normal ranges during the study. This study revealed thattreatment with S. reticulata was safe and well-tolerated and may be beneficial in the management of prediabetes and mild tomoderate hyperlipidemia.
KEY WORDS:  hyperlipidemia  leaves  lipid profile  prediabetes  Salacia reticulata  root barkP

Medicinal plants, since times immemorial, have been usedin virtually all cultures for controlling and preventing diabetes. In Ayurvedic medicine, Salacia species (e.g.,S. oblonga, S. prinoides, and S. reticulata) known as Ponkoranti, have been used for thousands of years for the treatment of diabetes. Salacia extracts have been extensively
consumed in Japan, the United States, and other countries as afood supplement for the prevention of obesity and diabetes.3
Traditionally, S. reticulata is ingested as an herbal tea (Kothala Himbutu tea), in which, a tea bag of the herbal mixture
is steeped in boiling water and ingested using a formula
passed on in an oral tradition to members of the family of the
ayurvedic physician.4 The roots and stems of S. reticulata andthe roots of S. oblonga have been extensively used for thetreatment of rheumatism, gonorrhea, skin diseases, and particularly as a specific remedy for the initial stages of diabetes
in the ayurvedic system of traditional medicine.3 In several
clinical studies, Salacia species have been reported for its
hypoglycemic activity.4–6 Thus, the present study aimed toinvestigate the efficacy and safety of S. reticulata leaves androot bark extracts in the management of patients with prediabetes and mild to moderate hyperlipidemia.
A randomized, double-blind, placebo-controlled experimental trial was designed to determine the efficacy andsafety of Salacia extracts as a dietary supplement forNot

rediabetes, also known as intermediate hyperglycemia, is a high-risk state for diabetes. It is defined as
glycemic variables that are higher than normal, but lower
than the diabetes threshold. About 5–10% of people per yearwith prediabetes will progress to diabetes, with the same
proportion converting back to normoglycemia. The worldwide prevalence of prediabetes is increasing and experts
have projected that more than 470 million people will haveprediabetes by the year 2030.1 Prediabetes is associated withthe simultaneous presence of insulin resistance and b-cell
dysfunction—abnormalities that start before glucose changes are detectable. Those individuals suffering from prediabetes may often suffer from hyperlipidemia, hypertension,and insulin resistance-linked obesity—all factors that sharply increase the risk of heart disease.1 Management includes
reducing cardiovascular disease risk factors, specifically lipid and blood pressure abnormalities. Intensive lifestyleintervention is required to prevent progression of prediabetes
to diabetes.2

Manuscript received 15 October 2012. Revision accepted 24 February 2013.
Address correspondence to: M. Bhanumathy, MPharm, Research and Development
Centre, Olive Lifesciences Pvt. Ltd., Sahakar Nagar, Bengaluru 560 092, India, E-mail:bhanumathy@olivelifesciences.com

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EFFICACY OF SALACIA: A DOUBLE-BLIND STUDY

lowering lipids and blood sugar levels. The study protocol
was reviewed and approved by the Institutional Ethics
Committee (Bangalore, India). The trial was conducted inaccordance with the principles of Good Clinical Practice andthe Declaration of Helsinki. Patients were eligible for enrolment according to the following selection criteria:

Patients were excluded from participation according to thefollowing criteria:
 Age less than 18 years or over 65 years.
 Suffering from advanced chronic illness that would
impair follow-up or monitoring.
 Women who were pregnant or breastfeeding and women of childbearing age.

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 As per Adult Treatment Panel III guidelines: Baseline
low-density lipoprotein cholesterol (LDL-C) ranging
160–189 mg/dL, total cholesterol > 200 mg/dL, andwith no or one of the below risk factors+ Current cigarette smoking+ Family history of premature coronary heart disease+ Hypertension (blood pressure > 140/90 mmHg or on
antihypertensive medication)+ Low high-density lipoprotein cholesterol (HDL-C< 40 mg/dL)+ Age (men > 40 years; women > 40 years)
 Patients with impaired glucose tolerance or impaired
fasting blood sugar (FBS).
 Patients being mentally competent and able to understand all study requirements and sign the informed
consent form.

Not

FIG. 1. Study flowchart.

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SHIVAPRASAD ET AL.

Table 1. Characteristics of the Patients at Baseline
Placebo(n = 9)

Salacia root
bark extract(n = 9)43.00 – 1.53
73.11 – 2.47
166.45 – 1.94
77.27 – 3.33

51.66 – 3.56
70.56 – 1.84
169.44 – 2.68
82.22 – 3.15

125.45 – 2.61

138.00 – 10.34

79.45 – 1.75

85.22 – 1.10

Lipid profile(mg/dL)LDL-C
TC
VLDL-C
HDL-C

Placebo

Salacia leaves
extract

Salacia root
bark extract

Week 3 158.55 – 1.18 154.45 – 1.71 144.66 – 3.00**
Week 6 153.55 – 1.59 144.90 – 1.81 138.11 – 2.90**
Week 3 229.66 – 3.75 224.18 – 5.32 215.44 – 6.80
Week 6 225.33 – 3.89 217.72 – 5.30 209.00 – 5.26
Week 3 24.22 – 1.94 24.27 – 3.43
24.33 – 2.97
Week 6 23.66 – 2.38 25.00 – 3.43
24.44 – 2.81
Week 3 46.88 – 1.64 45.45 – 2.1847.55 – 2.07
Week 6 48.11 – 1.96 47.81 – 1.48
48.66 – 1.89
Week 3 145.44 – 7.05 144.81 – 12.50 109.22 – 8.11
Week 6 143.55 – 6.58 133.54 – 11.54 111.88 – 7.54

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Age (years)
49.11 – 2.73
Weight (kg)66.14 – 3.14
Height (cm)163.00 – 2.59
Pulse rate
88.22 – 2.54(beats/min)BP systolic
126.88 – 1.379(mmHg)
BP diastolic
82.22 – 1.22(mmHg)
Lipid profile (mg/dL)
LDL-C
165.04 – 1.19
TC
237.77 – 4.17
VLDL-C
28.15 – 1.79
HDL-C
43.21 – 2.39
TG
147.77 – 7.31
Glycemic values (mg/dL)
FBS
116.11 – 1.76
OGTT
170.55 – 6.93

Salacia leaves
extract(n = 11)

Table 2. Effect of Salacia Extracts on Serum Lipid
Profile in Patients with Prediabetes
and Mild to Moderate Hyperlipidemia

164.00 – 1.10
236.27 – 3.40
28.74 – 2.31
43.72 – 1.90
153.36 – 15.57

165.68 – 3.32
233.00 – 6.28
22.40 – 1.62
44.00 – 2.67
114.88 – 9.34

115.54 – 1.43
170.09 – 4.95

115.22 – 1.35
165.00 – 5.29

Data are expressed as mean – SEM.
BP, blood pressure; FBS, fasting blood sugar; HDL-C, high-density
lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol; OGTT,
oral glucose tolerance test; TC, total cholesterol; TG, triglycerides; VLDL-C,
very low-density lipoprotein cholesterol; SEM, standard error of the mean.

 Those subjects unable to complete follow-up and subjects on any medication that would affect evaluation ofSalacia drug.
 Patients with mental illness or dementia, with a historyof drug and/or alcohol abuse, subjects allergic to any
medication.

Data are expressed as mean – SEM.
**P < .01.

receive Salacia extracts (leaves [n = 11] and root bark[n = 9]) 500 mg/day or placebo 500 mg/day (n = 9) alongwith therapeutic lifestyle changes for 6 weeks (Fig. 1).
Salacia extracts or placebo were orally administered twice aday (500 mg/day in two divided doses) 20 min before
breakfast and dinner. The dosing schedule was maintained
for the duration of the study. The subjects were followed up
for 6 weeks. At week 3 and 6, the changes in serum lipid
profile and glycemic levels were measured. The physicalexamination and clinical laboratory evaluations were carriedout on week 6.
Efficacy was assessed by measuring the serum lipid
profile (LDL-C, total cholesterol, very low-density lipoprotein cholesterol, HDL-C, and triglycerides) and glucose
levels (FBS and oral glucose tolerance test [OGTT]) on
week 3 and 6 in patients with prediabetes and mild tomoderate hyperlipidemia. On completion of the 6-weektreatment, each subject was specifically questioned about
the presence or absence of any side effects, which the patientNot

Subjects were randomly assigned to the treated groups or theplacebo group by an automated randomization system.
The investigational substance (Salacia leaves and root
bark extracts) were developed by M/s. Olive Lifesciences
Pvt. Ltd. (Bangalore, India). Subjects were randomized toTG

FIG. 2. The effect of Salacia extracts on thelow-density lipoprotein cholesterol (LDL-C)
level in patients with prediabetes and mild tomoderate hyperlipidemia. **P < .01.

EFFICACY OF SALACIA: A DOUBLE-BLIND STUDY
Table 3. Effect of Salacia Extracts on Glycemic
Levels in Patients with Prediabetes and Mildto Moderate Hyperlipidemia
Variables

PlaceboGlycemic levels (mg/dL)
FBS
Week 3 111.11 – 1.86
Week 6 109.22 – 1.54
OGTT
Week 3 162.00 – 6.57
Week 6 158.00 – 5.66

Salacia leaves
extract

Salacia root
bark extract

105.81 – 2.56
98.44 – 2.96**
100.81 – 2.30* 95.88 – 2.47**
159.09 – 5.01 143.00 – 5.68
149.45 – 5.39 142.55 – 4.97

were found in other serum lipids among the groups; however, a nonsignificant decreasing tendency was observed in
total cholesterol and TG levels at week 3 and 6. The change
in glycemic levels of treated groups is summarized in Table
3. In comparison with the placebo group, the Salacia root
bark extract-treated group showed a significant decrease(P < .01) in the FBS level at week 3 and 6. The Salacia leaf
extract-treated group showed a statistical significant decrease (P < .05) in the FBS level only at week 6 (Fig. 3). No
significant differences were found in the OGTT level between the groups; however, a nonsignificant decreasing
tendency was observed at week 3 and 6.
The physical examination and clinical laboratory investigations performed on day 0 and week 6 in the placebo andtreated groups were found to be within normal limits. No
adverse events were reported in patients treated with Salacia
extracts. Thus, the treatment with Salacia extracts wasfound to be safe and well-tolerated by all patients during thecomplete intervention period. The results of this study will
provide valuable information on the efficacy and safety ofSalacia extracts in managing prediabetes and mild tomoderate hyperlipidemia by lowering plasma cholesterollevels and glycemic levels. S. reticulata contains kotalanol,
an a-glucosidase inhibitor, which has an action similar tothat of acarbose. Active ingredients of Salacia include
salacinol, kotalanol, kotalagenin-16 acetate, and mangiferin. The active ingredients have a variety of actions,
including postprandial glucose decrease by inhibiting aglucosidases in the intestinal brush border, and thus slowing
carbohydrate breakdown into absorbable monosaccharides.
The mechanism of action is therefore similar to a-glucosidaseinhibitors such as acarbose. The catechin and tannin content
may contribute to weight loss properties.7 Due to the presence of the a-glucosidase inhibitor ingredient in Salacia, patients with prediabetes and mild to moderate hyperlipidemia
exhibited improvements in serum lipid profiles and glycemic
levels when treated with Salacia extracts. Changes in lifestyle,including a balanced diet and regular physical exercise mayFIn orte Ror nd ev
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Data are expressed as mean – SEM.
*P < .05, **P < .01.

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or the physician may attribute to the drug treatment. Alongwith this, a physical examination and clinical laboratory
evaluations such as electrocardiogram, hematology, biochemical tests, liver function test, and urine analysis werecarried out during the initial and final visits.
Data were presented as a mean value and a standard errorof the mean. Statistical analysis was performed using oneway analysis of variance followed by the Dunnett’s t test. The
statistical significance was set at P < .05 and P < .01. The
above statistical applications were performed using Instat ver.
5.00 (GraphPad Software, Inc., San Diego, CA, USA).
A total of 29 patients who fulfilled the selection criteria
and willing to give informed consent were enrolled in the
study and randomly assigned into three groups (placebo,Salacia leaf extract, and Salacia root bark extract). The
characteristics of the patients like age, weight, height, pulse
rate, blood pressure (diastolic and systolic), serum lipid
profile, and glycemic levels of all groups at baseline aresummarized in Table 1. Changes in serum lipid profile oftreated groups are summarized in Table 2. In comparison
with the placebo group, the Salacia root bark extract-treatedgroup showed a significant decrease (P < .01) in LDL-Clevels at week 3 and 6 (Fig. 2). No significant differences

FIG. 3. The effect of Salacia extracts on thefasting blood sugar (FBS) level in patientswith prediabetes and mild to moderate hyperlipidemia. *P < .05, **P < .01.

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SHIVAPRASAD ET AL.
2. Twigg SM, Kamp MC, Davis TM, Neylon EK, Flack JR: Prediabetes: A position statement from the Australian Diabetes Society and Australian Diabetes Educators Association. Med J Aust
2007;186:461–465.
3. Arunakumara KKIU, Subasinghe S: Salacia reticulata Wight: Areview of botany, phytochemistry and pharmacology. Tropic AgricRes Ext 2012;13:41–47.
4. Williams JA, Choe YS, Noss MJ, Baumgartner CJ, Mustad VA:
Extract of Salacia oblonga lowers acute glycemia in patients withtype 2 diabetes. Am J Clin Nutr 2007;86:124–130.
5. Jayawardena MH, de Alwis NM, Hettigoda V, Fernando DJ: Adouble blind randomised placebo controlled cross over studyof a herbal preparation containing Salacia reticulata in thetreatment of type 2 diabetes. J Ethnopharmacol 2005;97:215–218.
6. Hertzler S, Washam M, Williams J: Salacia oblonga extract reduces postprandial glycemia following a solid, high-starch meal.
FASEB J 2007;21:832–839.
7. Shane-McWhorter L: Dietary supplements for diabetes: An evaluation of commonly used products. Diabetes Spectr 2009;22:206–213.

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serve as adjunct therapies for decreasing LDL-C and glycemia
levels. Thus, Salacia extracts can be used as a dietary supplement in the management of patients with prediabetes andmild to moderate hyperlipidemia.
Based on the results obtained, it can be concluded thatpatients with prediabetes and mild to moderate hyperlipidemia treated with Salacia extracts for 6 weeks should realize
positive changes in the lipid profile and blood glucose level.
Thus, the herbal supplement (Salacia extracts) may bebeneficial for maintaining lipids and glucose at normal
levels in patients with prediabetes and mild to moderatehyperlipidemia.
AUTHOR DISCLOSURE STATEMENT
No competing financial interests exist.
REFERENCES

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1. Aroda VR, Ratner R: Approach to the patient with prediabetes.
J Clin Endocrinol Metab 2008;93:3259–3265.