Clinical trial NCT03155269: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Growth and Development
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2017-05-16
Enrollment: 114
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.
* Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit.
* Previous participation in this study.
* Recent history (within the last 1 year) of alcohol or other substance abuse.
* More than 2 Units of alcohol per day
* Smokers
* Currently taking any other health food drinks/beverages or supplements (including nutritional supplements e.g. multivitamins and/or herbal supplements e.g. ginkgo) or has been on supplements within a month prior to study start.
* 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.
* An employee of the sponsor or the study site or members of their immediate family.
* Ongoing conditions known to cause abnormalities of calcium metabolism or skeletal health, malabsorption syndromes (such as coeliac or Crohn's disease), hyperthyroidism, hyperparathyroidism, hypo- or hypercalcaemia, osteomalacia, Paget's disease, and diabetes.
* Fracture in the past 12 months.
* Known chronic kidney disease or alcoholism.
* Obesity women ( Body Mass Index, BMI\>30) and Thinness i.e. BMI\<18 kg/m2
* Severely anemic (Hemoglobin, Hb\<8 g/dl, Grams Per Decilitre).
* Undertaking excessive exercise (\>2 strenuous\* exercise sessions per week)
* 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 e.g. Hemophilia, Leukemia and lymphomas monoclonal multiple myeloma, sickle cell disease, Thalassemia etc.
* Rheumatological and autoimmune disorders such as ankylosing spondylitis, rheumatoid arthritis, systemic lupus etc.
* Miscellaneous conditions and diseases such as Human Immunodeficiency Virus/acquired immunodeficiency syndrome (HIV/AIDS), alcoholism, amyloidosis, chronic metabolic acidosis, Chronic Obstructive Pulmonary Disease (COPD), congestive heart failure, depression etc.

Primary outcomes:
measure: Change From Baseline in Serum Cross Linking C-telopeptide of Type 1 Collagen (s-CTX-1) at 6 Months
timeFrame: At baseline and at 6 months
measure: Change From Baseline in the Ratio of Carboxylated (c-OC) to Under-carboxylated Osteocalcin (Uc-OC) at 6 Months
timeFrame: At baseline and 6 months
Secondary outcomes:
measure: Change From Baseline in Serum Cross Linking C-telopeptide of Type 1 Collagen (s-CTX-1) at 3 Months
timeFrame: At baseline and at 3 months
measure: Change From Baseline in the Ratio of Carboxylated (c-OC) to Under-carboxylated Osteocalcin (Uc-OC) at 3 Months
timeFrame: At baseline and at 3 months
measure: Change From Baseline in Urinary Cross Linking C-telopeptide of Type 1 Collagen at 3 Months and 6 Months
timeFrame: At baseline, at 3 and 6 months
measure: Change From Baseline in Serum N-terminal Telopeptide of Type 1 Collagen (s-NTX-1) at 3 Months and 6 Months
timeFrame: At baseline, at 3 months and 6 months
measure: Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (s-P1NP) at 3 Months and 6 Months
timeFrame: At baseline, at 3 months and 6 months
measure: Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at 3 Months and 6 Months
timeFrame: At baseline, at 3 months and 6 months
measure: Change From Baseline in Serum Parathyroid Hormone (s-PTH) at 3 Months and 6 Months
timeFrame: At baseline, at 3 months and 6 months
measure: Change From Baseline in Urinary Calcium at 3 Months and 6 Months
timeFrame: At baseline, at 3 months and 6 months
measure: Change From Baseline in Serum Calcium at 3 Months and 6 Months
timeFrame: At baseline, at 3 months and 6 months
measure: Change From Baseline in Serum Phosphorus at 3 Months and 6 Months
timeFrame: At baseline, at 3 months and 6 months
measure: Change From Baseline in Total Alkaline Phosphatase (ALP) at 3 Months and 6 Months
timeFrame: At baseline, at 3 months and 6 months
measure: Change From Baseline in Serum Vitamin D3 Using 25-hydroxycholecalciferol (25 OH D3) at 3 Months and 6 Months
timeFrame: At baseline, at 3 months and 6 months
measure: Change From Baseline in Serum Selenium (Se) at 3 Months and 6 Months
timeFrame: At baseline, at 3 months and 6 months
measure: Change From Baseline in Plasma Zinc (Zn) at 3 Months and 6 Months
timeFrame: At baseline, at 3 months and 6 months
measure: Change From Baseline in Serum Folic Acid (Folate) at 3 Months and 6 Months
timeFrame: At baseline, at 3 months and 6 months
measure: Change From Baseline in Plasma Vitamin-B6 at 3 Months and 6 Months
timeFrame: At baseline, at 3 months and 6 months
measure: Change From Baseline in Serum Vitamin-B12 at 3 Months and 6 Months
timeFrame: At baseline, at 3 months and 6 months
Other outcomes:
Locations:
city: Pune
country: India
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
affiliation: GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: