To Investigate the Impact of a Nutritional Supplement on Bone Turnover Markers in Indian Healthy Premenopausal Women (25- 45 Years) After 6 Months of Intervention
CompletedNAResults postedLast updated 12 April 2019
What this trial tests
NA trial testing Fortified Beverage Powder in Growth and Development in 114 participants. Completed in 16 January 2018.
Adults 25 to 45, female only, with Growth and Development. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Serum Cross Linking C-telopeptide of Type 1 Collagen (s-CTX-1) at 6 MonthsPrimary· At baseline and at 6 months
s-CTX-1 is a bone resorption marker which is used to assess the bone health. After 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. CTX-1 serum was analysed using biochemical tests from the samples stored. Decreased s-CTX-1 is associated with improved bone health.
At Baseline
Group
Value
95% CI
Test Product
0.4440
± 0.11932
Reference Product
0.4410
± 0.16213
At 6 months
Group
Value
95% CI
Test Product
0.2828
± 0.14218
Reference Product
0.3245
± 0.16755
Change from baseline at 6 months
Group
Value
95% CI
Test Product
-0.1612
± 0.15011
Reference Product
-0.1165
± 0.16574
Change From Baseline in the Ratio of Carboxylated (c-OC) to Under-carboxylated Osteocalcin (Uc-OC) at 6 MonthsPrimary· At baseline and 6 months
c-OC/ uc-OC is considered as a surrogate marker of bone formation which is used to assess the bone health. After 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. c-OC/ uc-OC levels were analysed using biochemical tests from the samples stored. Increased c-OC/ uc-OC is associated with improved bone health.
At baseline
Group
Value
95% CI
Test Product
1.208
± 0.7573
Reference Product
1.138
± 0.6747
At 6 months
Group
Value
95% CI
Test Product
1.492
± 0.6666
Reference Product
1.251
± 0.4858
Change from baseline at 6 months
Group
Value
95% CI
Test Product
0.284
± 0.8961
Reference Product
0.113
± 0.7160
Change From Baseline in Serum Cross Linking C-telopeptide of Type 1 Collagen (s-CTX-1) at 3 MonthsSecondary· At baseline and at 3 months
s-CTX-1 is a bone resorption marker which is used to assess the bone health. After 3 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. CTX-1 serum was analysed using biochemical tests from the samples stored. Decreased s-CTX-1 is associated with improved bone health.
At baseline
Group
Value
95% CI
Test Product
0.4440
± 0.11932
Reference Product
0.4410
± 0.16213
At 3 months
Group
Value
95% CI
Test Product
0.2996
± 0.15762
Reference Product
0.3302
± 0.16693
Change from baseline at 3 months
Group
Value
95% CI
Test Product
-0.1444
± 0.14563
Reference Product
-0.1108
± 0.13265
Change From Baseline in the Ratio of Carboxylated (c-OC) to Under-carboxylated Osteocalcin (Uc-OC) at 3 MonthsSecondary· At baseline and at 3 months
c-OC/ uc-OC is considered as a surrogate marker of bone formation which is used to assess the bone health. After 3 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. c-OC/ uc-OC levels were analysed using biochemical tests from the samples stored. Increased c-OC/ uc-OC is associated with improved bone health.
At baseline
Group
Value
95% CI
Test Product
1.208
± 0.7573
Reference Product
1.138
± 0.6747
At 3 months
Group
Value
95% CI
Test Product
1.706
± 1.2083
Reference Product
1.192
± 0.8305
Change from baseline at 3 months
Group
Value
95% CI
Test Product
0.498
± 1.3043
Reference Product
0.054
± 0.8868
Change From Baseline in Urinary Cross Linking C-telopeptide of Type 1 Collagen at 3 Months and 6 MonthsSecondary· At baseline, at 3 and 6 months
Urinary-CTX-1 is a bone resorption surrogate marker which is used to assess the bone health. After 3 months and 6 months of taking the allocated product, spot urinary sample were collected. CTX-1 urine levels were analysed using biochemical tests from the samples stored. Decreased urinary CTX-1 is associated with improved bone health.
At baseline
Group
Value
95% CI
Test Product
23.153
± 17.3511
Reference Product
25.137
± 22.8524
At 3 months
Group
Value
95% CI
Test Product
21.105
± 16.8386
Reference Product
31.864
± 27.5339
Change from baseline at 3 months
Group
Value
95% CI
Test Product
-1.309
± 20.8967
Reference Product
6.727
± 22.7372
At 6 months
Group
Value
95% CI
Test Product
16.318
± 17.1383
Reference Product
18.708
± 20.6598
Change from baseline at 6 months
Group
Value
95% CI
Test Product
-6.835
± 22.1252
Reference Product
-6.429
± 27.9624
Change From Baseline in Serum N-terminal Telopeptide of Type 1 Collagen (s-NTX-1) at 3 Months and 6 MonthsSecondary· At baseline, at 3 months and 6 months
NTX-1 is a bone resorption surrogate marker which is used to assess the bone health. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. NTX-1 serum was analysed using biochemical tests from the samples stored. Decreased s-NTX-1 is associated with improved bone health. The unit of measurement is nanomole bone collagen equivalent (NM BCE).
At baseline
Group
Value
95% CI
Test Product
11.64
± 3.373
Reference Product
11.87
± 3.093
At 3 months
Group
Value
95% CI
Test Product
10.68
± 6.315
Reference Product
10.00
± 5.720
Change from baseline at 3 months
Group
Value
95% CI
Test Product
-0.97
± 6.466
Reference Product
-1.99
± 5.861
At 6 months
Group
Value
95% CI
Test Product
8.22
± 3.146
Reference Product
9.38
± 4.157
Change from baseline at 6 months
Group
Value
95% CI
Test Product
-3.43
± 4.072
Reference Product
-2.49
± 4.296
Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (s-P1NP) at 3 Months and 6 MonthsSecondary· At baseline, at 3 months and 6 months
P1NP is a bone formation surrogate marker which is used to assess the bone health being the most abundant protein of bone matrix. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. P1NP serum was analysed using biochemical tests from the samples stored. Increased s-P1NP is associated with improved bone health.
At baseline
Group
Value
95% CI
Test Product
59.61
± 22.044
Reference Product
58.70
± 23.133
At 3 months
Group
Value
95% CI
Test Product
46.64
± 17.982
Reference Product
54.22
± 20.592
Change from baseline at 3 months
Group
Value
95% CI
Test Product
-12.96
± 15.929
Reference Product
-4.85
± 16.498
At 6 months
Group
Value
95% CI
Test Product
43.86
± 14.194
Reference Product
51.12
± 22.586
Change from baseline at 6 months
Group
Value
95% CI
Test Product
-15.75
± 18.272
Reference Product
-7.58
± 18.037
Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at 3 Months and 6 MonthsSecondary· At baseline, at 3 months and 6 months
BSAP is a bone formation surrogate marker which is used to assess the bone health. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. BSAP serum was analysed using biochemical tests from the samples stored. Increased s-BSAP is associated with improved bone health.
At baseline
Group
Value
95% CI
Test Product
11.071
± 4.1076
Reference Product
10.774
± 3.0623
At 3 months
Group
Value
95% CI
Test Product
9.441
± 4.3417
Reference Product
10.188
± 3.0810
Change from baseline at 3 months
Group
Value
95% CI
Test Product
-1.649
± 1.8695
Reference Product
-0.586
± 1.7019
At 6 months
Group
Value
95% CI
Test Product
10.013
± 3.3193
Reference Product
11.754
± 3.3887
Change from baseline at 6 months
Group
Value
95% CI
Test Product
-1.058
± 4.1670
Reference Product
0.980
± 1.4648
Change From Baseline in Serum Parathyroid Hormone (s-PTH) at 3 Months and 6 MonthsSecondary· At baseline, at 3 months and 6 months
PTH is used to compare calcium concentration status which defines the healthy bones. Intact PTH is the biologically active form and is secreted when the calcium level is low. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. PTH serum was analysed using biochemical tests from the samples stored. Decreased s-PTH is associated with improved bone health.
At baseline
Group
Value
95% CI
Test Product
5.73
± 2.875
Reference Product
5.35
± 2.499
At 3 months
Group
Value
95% CI
Test Product
4.99
± 3.394
Reference Product
5.75
± 2.602
Change from baseline at 3 months
Group
Value
95% CI
Test Product
-0.66
± 2.798
Reference Product
0.34
± 2.479
At 6 months
Group
Value
95% CI
Test Product
7.27
± 3.429
Reference Product
8.09
± 4.303
Change from baseline at 6 months
Group
Value
95% CI
Test Product
1.53
± 3.126
Reference Product
2.69
± 4.143
Change From Baseline in Urinary Calcium at 3 Months and 6 MonthsSecondary· At baseline, at 3 months and 6 months
Urinary calcium is used to compare calcium concentration status which defines the healthy bones. After 3 months and 6 months of taking the allocated product, spot urinary sample were collected. Urinary calcium was analysed using biochemical tests from the samples stored. Decreased urinary calcium is associated with improved bone health.
At baseline
Group
Value
95% CI
Test Product
104.5
± 78.26
Reference Product
104.0
± 82.26
At 3 months
Group
Value
95% CI
Test Product
161.5
± 142.60
Reference Product
116.9
± 131.53
Change from baseline at 3 months
Group
Value
95% CI
Test Product
61.3
± 126.75
Reference Product
16.4
± 98.00
At 6 months
Group
Value
95% CI
Test Product
338.3
± 440.08
Reference Product
549.7
± 851.54
Change from baseline at 6 months
Group
Value
95% CI
Test Product
235.3
± 451.33
Reference Product
448.9
± 846.48
Change From Baseline in Serum Calcium at 3 Months and 6 MonthsSecondary· At baseline, at 3 months and 6 months
Serum calcium is used to compare calcium concentration status which defines the healthy bones. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Serum calcium was analysed using biochemical tests from the samples stored. Increased serum calcium is associated with improved bone health.
At baseline
Group
Value
95% CI
Test Product
2.299
± 0.0629
Reference Product
2.296
± 0.0703
At 3 months
Group
Value
95% CI
Test Product
2.266
± 0.0778
Reference Product
2.258
± 0.0862
Change from baseline at 3 months
Group
Value
95% CI
Test Product
-0.038
± 0.0854
Reference Product
-0.037
± 0.0825
At 6 months
Group
Value
95% CI
Test Product
2.359
± 0.0835
Reference Product
2.326
± 0.0792
Change from baseline at 6 months
Group
Value
95% CI
Test Product
0.060
± 0.0873
Reference Product
0.030
± 0.0821
Change From Baseline in Serum Phosphorus at 3 Months and 6 MonthsSecondary· At baseline, at 3 months and 6 months
Serum phosphorus is a diagnostic marker for assessment of healthy bones. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Serum phosphorus was analysed using biochemical tests from the samples stored. Increased serum phosphorus is associated with improved bone health.
At baseline
Group
Value
95% CI
Test Product
1.138
± 0.1286
Reference Product
1.127
± 0.1378
At 3 months
Group
Value
95% CI
Test Product
1.157
± 0.1879
Reference Product
1.184
± 0.1621
Change from baseline at 3 months
Group
Value
95% CI
Test Product
0.023
± 0.1832
Reference Product
0.062
± 0.1580
At 6 months
Group
Value
95% CI
Test Product
1.127
± 0.1493
Reference Product
1.123
± 0.1810
Change from baseline at 6 months
Group
Value
95% CI
Test Product
-0.012
± 0.1617
Reference Product
-0.004
± 0.1940
Adverse events — posted to ClinicalTrials.gov
Time frame: 180 days +/- 7.
Reporting threshold: 1%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
To investigate the effect of nutritional supplement on bone turnover markers (which are sensitive and respond quickly to nutrition or drug intervention) in Indian healthy premenopausal women after 6 months of intervention.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 12 April 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03155269.