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

NCT03155269 | Completed Results

• 1 other identifier: 207192
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Growth and Development

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Serum Cross Linking C-telopeptide of Type 1 Collagen (s-CTX-1) 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 and at 6 months

• Change From Baseline in the Ratio of Carboxylated (c-OC) to Under-carboxylated Osteocalcin (Uc-OC) at 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 and 6 months

Secondary Outcomes (17)

• 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 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 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 Serum Procollagen Type 1 N-terminal Propeptide (s-P1NP) at 3 Months and 6 Months

  At baseline, at 3 months and 6 months

Study Arms (2)

Group 1- Protein rich beverage powder fortified with MMN

EXPERIMENTAL

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 morning and evening for 6 months.

Dietary Supplement: Fortified Beverage Powder

Group 2 -Low protein non-fortified iso-caloric beverage powder

OTHER

Participants will be administered orally two doses (in morning and evening) of low protein non fortified isocaloric beverage (30 grams powder made up in 200 mL water) daily for 6 months.

Dietary Supplement: Non fortified beverage Powder

Interventions

Fortified Beverage Powder DIETARY_SUPPLEMENT

The tumbler will be filled with water up to the 200 mL mark. The entire contents of one sachet (Fortified beverage powder) will be gradually emptied in the tumbler with intermittent stirring to avoid formation of lumps. The reconstituted product will be consumed by the participants immediately orally.

Group 1- Protein rich beverage powder fortified with MMN

Non fortified beverage Powder DIETARY_SUPPLEMENT

The tumbler will be filled with water up to the 200 mL mark. The entire contents of one sachet (Non fortified beverage powder) will be gradually emptied in the tumbler with intermittent stirring to avoid formation of lumps. The reconstituted product will be consumed by the participants immediately orally.

Group 2 -Low protein non-fortified iso-caloric beverage powder

Eligibility Criteria

• Age: 25 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Pune, 411001, India

Location

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

• GSK Clinical Trials

  GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 16, 2017
• Study Start: May 25, 2017
• Primary Completion: January 16, 2018
• Study Completion: January 16, 2018
• Last Updated: April 12, 2019
• Results First Posted: April 12, 2019

Record last verified: 2019-01

Locations

IN (1)