Impact of a Nutritional Supplement on Bone Turnover Markers in Indian Healthy Premenopausal Women (25-45 Yrs; Inclusive) After 6 Months of Intervention: a Randomised Double Blind Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Growth and Development
- Sponsor
- GlaxoSmithKline
- Enrollment
- 114
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Serum Cross Linking C-telopeptide of Type 1 Collagen (s-CTX-1) at 6 Months
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed Description
This will be a double blind, single-center, randomized-controlled trial testing the effect of fortified beverage on bone turnover markers as compared to placebo control in 25-45 years old premenopausal women. The study will consist of two groups: Group 1 (Test) - Protein rich beverage powder fortified with MMN and Group 2 (control) - Low protein non-fortified iso-caloric beverage powder.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- •Female Participants.
- •Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon physical examination.
- •BMI between 18.0-30 (kg/m2, Kilograms Per Meter Square) inclusive.
- •Women who understand, willing, able and likely to comply with all study procedures and restrictions.
Exclusion Criteria
- •Women who are known to be pregnant or who are intending to become pregnant over the duration of the study or Women who have a positive urine pregnancy test.
- •Women who have attained physiological menopause defined as those who have not had a menstrual period for consecutive 12 months.
- •Women who are breast-feeding.
- •Current (within 14 days of the start of the study) or regular use of any prescription, over the counter (OTC), vitamin supplements herbal medicine unless the medication has been approved by the study physician.
- •Treatment with bisphosphonates (any dose within the previous 2 years) or other medications known to affect bone (within the previous 6 months).
- •History of metabolic bone disease.
- •Any hormonal disorders or disturbances.
- •Bone fracture in last 12 months.
- •Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- •Participant is lactose intolerant.
Outcomes
Primary Outcomes
Change From Baseline in Serum Cross Linking C-telopeptide of Type 1 Collagen (s-CTX-1) at 6 Months
Time Frame: 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.
Change From Baseline in the Ratio of Carboxylated (c-OC) to Under-carboxylated Osteocalcin (Uc-OC) at 6 Months
Time Frame: 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.
Secondary Outcomes
- Change From Baseline in Serum Cross Linking C-telopeptide of Type 1 Collagen (s-CTX-1) at 3 Months(At baseline and at 3 months)
- Change From Baseline in the Ratio of Carboxylated (c-OC) to Under-carboxylated Osteocalcin (Uc-OC) at 3 Months(At baseline and at 3 months)
- Change From Baseline in Serum N-terminal Telopeptide of Type 1 Collagen (s-NTX-1) at 3 Months and 6 Months(At baseline, at 3 months and 6 months)
- Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at 3 Months and 6 Months(At baseline, at 3 months and 6 months)
- Change From Baseline in Serum Folic Acid (Folate) at 3 Months and 6 Months(At baseline, at 3 months and 6 months)
- Change From Baseline in Serum Vitamin-B12 at 3 Months and 6 Months(At baseline, at 3 months and 6 months)
- Change From Baseline in Urinary Cross Linking C-telopeptide of Type 1 Collagen at 3 Months and 6 Months(At baseline, at 3 and 6 months)
- Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (s-P1NP) at 3 Months and 6 Months(At baseline, at 3 months and 6 months)
- Change From Baseline in Serum Parathyroid Hormone (s-PTH) at 3 Months and 6 Months(At baseline, at 3 months and 6 months)
- Change From Baseline in Urinary Calcium at 3 Months and 6 Months(At baseline, at 3 months and 6 months)
- Change From Baseline in Total Alkaline Phosphatase (ALP) at 3 Months and 6 Months(At baseline, at 3 months and 6 months)
- Change From Baseline in Plasma Vitamin-B6 at 3 Months and 6 Months(At baseline, at 3 months and 6 months)
- Change From Baseline in Serum Calcium at 3 Months and 6 Months(At baseline, at 3 months and 6 months)
- Change From Baseline in Serum Phosphorus at 3 Months and 6 Months(At baseline, at 3 months and 6 months)
- Change From Baseline in Serum Vitamin D3 Using 25-hydroxycholecalciferol (25 OH D3) at 3 Months and 6 Months(At baseline, at 3 months and 6 months)
- Change From Baseline in Serum Selenium (Se) at 3 Months and 6 Months(At baseline, at 3 months and 6 months)
- Change From Baseline in Plasma Zinc (Zn) at 3 Months and 6 Months(At baseline, at 3 months and 6 months)