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

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Nutrova Functional Fibre: Clinical Study Results (http://nutrova.com/functional-fibre)

  • 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