Trials / Completed
CompletedNCT03155269
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
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 114 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- Female
- Age
- 25 Years – 45 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Fortified Beverage Powder | 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. |
| DIETARY_SUPPLEMENT | Non fortified beverage Powder | 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. |
Timeline
- Start date
- 2017-05-25
- Primary completion
- 2018-01-16
- Completion
- 2018-01-16
- First posted
- 2017-05-16
- Last updated
- 2019-04-12
- Results posted
- 2019-04-12
Locations
1 site across 1 country: India
Source: ClinicalTrials.gov record NCT03155269. Inclusion in this directory is not an endorsement.