Trial Outcomes & Findings for 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 (NCT NCT03155269)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

114 participants

Primary outcome timeframe

At baseline and at 6 months

Results posted on

2019-04-12

Participant Flow

Participants were recruited from one center in India.

A total of 117 participates were screened, out of which 114 participants were enrolled and allocated to a randomized treatment in the study (57 participants in each group), and 3 participants were not randomized due to withdrawl of consent.

Participant milestones

Participant milestones
Measure	Test Product Participants received the protein rich beverage powder fortified with multi-micronutrients (MMN). The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months.	Reference Product Participants received the low protein non fortified isocaloric beverage powder. The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months.
Overall Study STARTED	57	57
Overall Study COMPLETED	52	50
Overall Study NOT COMPLETED	5	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Test Product Participants received the protein rich beverage powder fortified with multi-micronutrients (MMN). The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months.	Reference Product Participants received the low protein non fortified isocaloric beverage powder. The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months.
Overall Study Withdrawal by Subject	4	5
Overall Study Lost to Follow-up	1	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test Product n=57 Participants Participants received the protein rich beverage powder fortified with multi-micronutrients (MMN). The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months.	Reference Product n=57 Participants Participants received the low protein non fortified isocaloric beverage powder. The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months.	Total n=114 Participants Total of all reporting groups
Age, Continuous	35.0 Years STANDARD_DEVIATION 4.41 • n=5 Participants	34.2 Years STANDARD_DEVIATION 4.79 • n=7 Participants	34.6 Years STANDARD_DEVIATION 4.60 • n=5 Participants
Sex: Female, Male Female	57 Participants n=5 Participants	57 Participants n=7 Participants	114 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	57 Participants n=5 Participants	57 Participants n=7 Participants	114 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Agr group Age 25- <35 years	26 Participants n=5 Participants	27 Participants n=7 Participants	53 Participants n=5 Participants
Agr group Age 35- <=45 years	31 Participants n=5 Participants	30 Participants n=7 Participants	61 Participants n=5 Participants
Height	152.8 Centimeters (cm) STANDARD_DEVIATION 4.92 • n=5 Participants	154.1 Centimeters (cm) STANDARD_DEVIATION 5.27 • n=7 Participants	153.4 Centimeters (cm) STANDARD_DEVIATION 5.12 • n=5 Participants
Weight	57.5 Kilograms (kg) STANDARD_DEVIATION 7.14 • n=5 Participants	59.6 Kilograms (kg) STANDARD_DEVIATION 8.52 • n=7 Participants	58.5 Kilograms (kg) STANDARD_DEVIATION 7.89 • n=5 Participants
Body Mass Index	24.7 Kilograms per meter squares (kg/m^2) STANDARD_DEVIATION 2.98 • n=5 Participants	25.0 Kilograms per meter squares (kg/m^2) STANDARD_DEVIATION 2.84 • n=7 Participants	24.8 Kilograms per meter squares (kg/m^2) STANDARD_DEVIATION 2.90 • n=5 Participants

PRIMARY outcome

Timeframe: At baseline and at 6 months

Population: The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.

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.

Outcome measures

Outcome measures
Measure	Test Product n=52 Participants Participants received the protein rich beverage powder fortified with multi-micronutrients (MMN). The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months.	Reference Product n=50 Participants Participants received the low protein non fortified isocaloric beverage powder. The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months.
Change From Baseline in Serum Cross Linking C-telopeptide of Type 1 Collagen (s-CTX-1) at 6 Months At Baseline	0.4440 Micrograms per litres (mcg/L) Standard Deviation 0.11932	0.4410 Micrograms per litres (mcg/L) Standard Deviation 0.16213
Change From Baseline in Serum Cross Linking C-telopeptide of Type 1 Collagen (s-CTX-1) at 6 Months At 6 months	0.2828 Micrograms per litres (mcg/L) Standard Deviation 0.14218	0.3245 Micrograms per litres (mcg/L) Standard Deviation 0.16755
Change From Baseline in Serum Cross Linking C-telopeptide of Type 1 Collagen (s-CTX-1) at 6 Months Change from baseline at 6 months	-0.1612 Micrograms per litres (mcg/L) Standard Deviation 0.15011	-0.1165 Micrograms per litres (mcg/L) Standard Deviation 0.16574

PRIMARY outcome

Timeframe: At baseline and 6 months

Population: The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.

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.

Outcome measures

Outcome measures
Measure	Test Product n=52 Participants Participants received the protein rich beverage powder fortified with multi-micronutrients (MMN). The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months.	Reference Product n=50 Participants Participants received the low protein non fortified isocaloric beverage powder. The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months.
Change From Baseline in the Ratio of Carboxylated (c-OC) to Under-carboxylated Osteocalcin (Uc-OC) at 6 Months At baseline	1.208 Ratio Standard Deviation 0.7573	1.138 Ratio Standard Deviation 0.6747
Change From Baseline in the Ratio of Carboxylated (c-OC) to Under-carboxylated Osteocalcin (Uc-OC) at 6 Months At 6 months	1.492 Ratio Standard Deviation 0.6666	1.251 Ratio Standard Deviation 0.4858
Change From Baseline in the Ratio of Carboxylated (c-OC) to Under-carboxylated Osteocalcin (Uc-OC) at 6 Months Change from baseline at 6 months	0.284 Ratio Standard Deviation 0.8961	0.113 Ratio Standard Deviation 0.7160

SECONDARY outcome

Timeframe: At baseline and at 3 months

Population: The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.

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.

Outcome measures

Outcome measures
Measure	Test Product n=52 Participants Participants received the protein rich beverage powder fortified with multi-micronutrients (MMN). The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months.	Reference Product n=50 Participants Participants received the low protein non fortified isocaloric beverage powder. The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months.
Change From Baseline in Serum Cross Linking C-telopeptide of Type 1 Collagen (s-CTX-1) at 3 Months At baseline	0.4440 mcg/L Standard Deviation 0.11932	0.4410 mcg/L Standard Deviation 0.16213
Change From Baseline in Serum Cross Linking C-telopeptide of Type 1 Collagen (s-CTX-1) at 3 Months At 3 months	0.2996 mcg/L Standard Deviation 0.15762	0.3302 mcg/L Standard Deviation 0.16693
Change From Baseline in Serum Cross Linking C-telopeptide of Type 1 Collagen (s-CTX-1) at 3 Months Change from baseline at 3 months	-0.1444 mcg/L Standard Deviation 0.14563	-0.1108 mcg/L Standard Deviation 0.13265

SECONDARY outcome

Timeframe: At baseline and at 3 months

Population: The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.

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.

Outcome measures

Outcome measures
Measure	Test Product n=52 Participants Participants received the protein rich beverage powder fortified with multi-micronutrients (MMN). The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months.	Reference Product n=50 Participants Participants received the low protein non fortified isocaloric beverage powder. The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months.
Change From Baseline in the Ratio of Carboxylated (c-OC) to Under-carboxylated Osteocalcin (Uc-OC) at 3 Months At baseline	1.208 Ratio Standard Deviation 0.7573	1.138 Ratio Standard Deviation 0.6747
Change From Baseline in the Ratio of Carboxylated (c-OC) to Under-carboxylated Osteocalcin (Uc-OC) at 3 Months At 3 months	1.706 Ratio Standard Deviation 1.2083	1.192 Ratio Standard Deviation 0.8305
Change From Baseline in the Ratio of Carboxylated (c-OC) to Under-carboxylated Osteocalcin (Uc-OC) at 3 Months Change from baseline at 3 months	0.498 Ratio Standard Deviation 1.3043	0.054 Ratio Standard Deviation 0.8868

SECONDARY outcome

Timeframe: At baseline, at 3 and 6 months

Population: The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.

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.