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1. EFFECT OF NUTROVA FUNCTIONAL
FIBRE ON CHOLESTEROL,
TRIGLYCERIDES AND QUALITY OF LIFE

2. STUDY DETAILS
CRO: Spectrum Clinical Research Pvt. Ltd.
STUDY CENTRE: Spectrum Health Care. 5th Floor , 56-57 Lady Ratan Tata
Medical & Research Centre, M. Karve Road, Cooperage,
Mumbai -4000 21.Maharashtra, India.
STUDY COMPLETION DATE: April 2013
The study was approved by ClinXXL Independent Ethics Committee. The submission
included the protocol, and informed consent forms in English and in local languages
(Hindi and Marathi). The IEC Committee was chaired by Dr.Daniel Joseph.
All p values were reported based on two sided significance test and all statistical tests
were interpreted at 5% level of significance

3. STUDY SUMMARY
• 70 subjects with elevated LDL were given Nutrova
Functional Fibre twice daily, 30 minutes before meals
for a period of 2 months.
• Subjects were either Diabetic (recently diagnosed
type 2 diabetes) or Non Diabetic. All patients had LDL
between 130 – 190 mg/dL.
• The effect on Cholesterol and other parameters was
measured on Day 0, Day 30 and Day 60 of the study.

4. SUBJECT PROFILE
Parameters Diabetic Non-diabetic
No. of cases 36 34
Age (yrs)
Mean
SD
Range
50.45
7.11
34-59 yrs
42.88
9.36
30-59 yrs
Sex (%)
Male
Female
09 (25.0%)
27 (75.0%)
23(67.6%)
11 (32.4%)
•63 subjects completed the study (31 Diabetic, 32 Non
Diabetic), the remainder were lost to follow up.
•The Diabetic group were on oral hypoglycemics. The
drug and dosage were not standardized.

5. EFFECT ON LDL CHOLESTEROL
• A statistically significant fall from baseline in LDL
cholesterol was observed on Day 30 and Day 60
• Day 30: 19.8% decrease in Diabetic group, 18.7%
in Non Diabetic group
• Day 60: 22.8% decrease in Diabetic group, 20.1%
decrease in Non Diabetic group

6. EFFECT ON LDL CHOLESTEROL
Duration in days
Mean LDL cholesterol (  SD)
Diabetic (N=31) Non- diabetic(N=32)
Baseline 141.24  10.67 140.28  8.99
30 113.24  20.53 114.10  27.25
60 109.05  22.52 112.09  30.22
Difference
( Baseline – 30)
p value
*-28.00  18.37
<0.0001
*-26.18  27.13
<0.0001
Difference
( Baseline – 60)
p value
*-32.19  20.78
<0.0001
*-28.19  29.22
<0.0001
By Student‘t’ Test * =Significant NS = Not significant

7. EFFECT ON LDL CHOLESTEROL
COMPARISON OF CHANGES IN MEAN LDL CHOLESTEROL BETWEEN THE
GROUPS
109.05113.24
141.24
112.09114.1
140.28
0
20
40
60
80
100
120
140
160
180
200
BASELINE 30 60
DURATION IN DAYS
MEANLDLCHOLESTEROL
DIABETIC
NON DIABETIC

8. EFFECT ON TRIGLYCERIDES
• A statistically significant fall from baseline in
Triglycerides was observed on Day 30 and Day 60
• Day 30: 16.0% decrease in Diabetic group, 15.9%
in Non Diabetic group
• Day 60: 15.2% decrease in Diabetic group, 12.3%
decrease in Non Diabetic group

9. EFFECT ON TRIGLYCERIDES
Duration in days
Mean triglycerides (  SD)
Diabetic (N=31) Non- diabetic(N=32)
Baseline 180.54  35.31 170.94  25.87
30 151.71  39.46 143.92  37.74
60 153.15  36.71 149.97  44.99
Difference
( Baseline – 30)
p value
*-28.83  24.42
<0.0001
*-27.02  31.60
<0.0001
Difference
( Baseline – 60)
p value
*-27.39  20.95
<0.0001
*-20.97  42.62
0.0091
By Student‘t’ Test * =Significant NS = Not significant

10. EFFECT ON TRIGLYCERIDES
COMPARISON OF CHANGES IN MEAN TRIGLYCERIDE BETWEEN THE GROUPS
153.15151.71
180.54
149.97143.92
170.94
0
50
100
150
200
250
300
350
400
BASELINE 30 60
DURATION IN DAYS
MEANTRIGLYCERIDE
DIABETIC
NON DIABETIC

11. EFFECT ON MEAN CHOLESTEROL
• A statistically significant fall from baseline in
Mean Cholesterol was observed on Day 30 and
Day 60
• Day 30: 14.0% decrease in Diabetic group, 14.6%
in Non Diabetic group
• Day 60: 14.7% decrease in Diabetic group, 15.5%
decrease in Non Diabetic group

12. EFFECT ON MEAN CHOLESTEROL
Duration in days
Mean Total Cholesterol (  SD)
Diabetic (N=31) Non- diabetic(N=32)
Baseline 221.96  18.55 216.71  12.34
30 190.87  31.19 185.05  30.77
60 189.42  32.83 183.09  33.02
Difference
( Baseline – 30)
p value
*-31.09  21.20
<0.0001
*-31.66  29.38
<0.0001
Difference
( Baseline – 60)
p value
*-32.54  24.13
<0.0001
*-33.62  33.28
<0.0001
X
By Student‘t’ Test * =Significant NS = Not significant

13. EFFECT ON MEAN CHOLESTEROL
COMPARISON OF CHANGES IN MEAN CHOLESTEROL BETWEEN THE
GROUPS
221.96
190.87 189.42
216.71
185.05 183.09
0
50
100
150
200
250
300
BASELINE 30 60
DURATION IN DAYS
MEANCHOLESTEROL
DIABETIC
NON DIABETIC

14. EFFECT ON QUALITY OF LIFE
• Subjects in the Diabetic and Non Diabetic group
showed a statistically significant improvement in
Quality of Life on Day 60.
16.1
54.8
22.6
6.5
12.9
77.4
9.7
9.7
87.1
3.2
25
31.2
34.4
9.4
15.6
65.6
18.8
6.3
12.5
81.2
0
10
20
30
40
50
60
70
80
90
100
PERCENTAGEOFCASES
Baseline 30 60 Baseline 30 60
DIABETIC NON DIABETIC
GROUPS
COMPARISION OF CHANGES IN PROPORTION OF CASES RATING
THEIR QUALITY OF LIFE
Very Good
Good
Neither Poor nor Good
Poor
Very poor

15. EFFECT ON QUALITY OF LIFE
Assessment
Diabetic (N=31) Non- diabetic (N=32)
Baseline
No. %
30 Day
No. %
60 DAY
No. %
Baseline
No. %
30 Day
No. %
60 DAY
No. %
Very poor 05 16.1 - - - - 08 25.0 - - - -
Poor 17 54.8 04 12.9 - - 10 31.2 05 15.6 02 06.3
Neither Poor nor
Good
07 22.6 24 77.4 03 09.7 11 34.4 21 65.6 04 12.5
Good 02 06.5 03 09.7 27 87.1 03 09.4 06 18.8 26 81.2
Very Good - - - - 01 03.2 - - - - - -
p value
(Within groups)
0.6409
(NS)
*<0.0001 0.2807
(NS)
*<0.0001
By Student‘t’ Test * =Significant NS = Not significant