None listed
Conditions
Interventions
Intervention1: Fortified Beverage Powder: Participants will be administered orally two doses of cereal based fortified beverage (30 grams powder made up in 200 milliliter (mL) water) daily in the morn
Sponsors
GlaxoSmithKline Consumer Healthcare GSKCH
Eligibility
Inclusion 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 to 30 Kilograms Per Meter Square) inclusive Women who understand willing able and likely to comply with all study procedures and restrictions
Exclusion criteria
Exclusion criteria: Pregnant women or who are intending to become pregnant over the duration of the study, Women who have attained physiological menopause, Women who are breast-feeding Current or regular use of any prescription, over the counter (OTC), vitamin supplements herbal medicine, Treatment with bisphosphonates or other medications known to affect bone, History of metabolic bone disease, hormonal disorders or disturbances, Bone fracture, intolerance or hypersensitivity to the study materials, Lactose intoletrance, Participation in another clinical study, Previous participation in this study, history of alcohol or other substance abuse, Smoker, Currently taking any other health food drinks/beverages or supplements, Women who used medication known to influence bone mass and the use of calcium, vitamin D, and multivitamin supplements on a regular basis were stopped 2 months before the onset of the trial. Ongoing conditions known to cause abnormalities of calcium metabolism or skeletal health, malabsorption syndromes (such as coeliac or Crohnâ??s disease), hyperthyroidism, hyperparathyroidism, hypo- or hypercalcaemia, osteomalacia, Pagetâ??s disease, and diabetes, Fracture in the past 12 months, chronic kidney disease, obesity, Severely anemic , Undertaking excessive exercise Contraceptive injections within the previous year, Known histories of surgeries such as bilateral oophrectomy (surgical removal of ovaries), Diagnosed hypogondal states such as Turner syndrome, Klinfelter syndrome, Kallman ,syndrome, anorexia nervosa, hypothalamic amenorrhea or hyperprolactinemia, Hemotological disorders, Rheumatological and autoimmune disorders, Miscellaneous conditions and diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in serum C-telopeptide of type 1 collagen and in the ratio of carboxylated (c-OC) to under-carboxylated Osteocalcin (uc-OC)Timepoint: At 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in 25-hydroxycholecalciferol (25 OH D3)Timepoint: At 3 and 6 months;Change from baseline in bone specific alkaline phosphatase (BSAP)Timepoint: At 3 and 6 months;Change from baseline in Plasma Vitamin B6Timepoint: At 3 and 6 months;Change from baseline in plasma Zinc (Zn)Timepoint: At 3 and 6 months;Change from baseline in s-CTX-1Timepoint: At 3 months;Change from baseline in serum calciumTimepoint: At 3 and 6 months;Change from baseline in serum folic acidTimepoint: At 3 and 6 months;Change from baseline in serum N-terminal telopeptide of type 1 collagen (s-NTX-1)Timepoint: At 3 and 6 months;Change from baseline in Serum Parathyroid Hormone (s-PTH)Timepoint: At 3 and 6 months;Change from baseline in serum phosphorusTimepoint: At 3 and 6 months;Change from baseline in serum procollagen type 1 N-terminal propeptide (s-P1NP)Timepoint: At 3 and 6 months;Change from baseline in serum selenium (Se)Timepoint: At 3 and 6 months;Change from baseline in serum Vitamin B12Timepoint: At 3 and 6 months;Change from baseline in the ratio of c-oc to uc-OCTimepoint: At 3 months;Change from baseline in total alkaline phosphatase (ALP)Timepoint: At 3 and 6 months;Change from baseline in urinary calciumTimepoint: At 3 and 6 months;Change from baseline in Urinary CTX-1Timepoint: At 3 and 6 months | — |
Countries
India
Contacts
Public ContactDR PRAMOD B UMARJI
B.J. Govt. Medical College and Sassoon General Hospital
Outcome results
None listed