NCT04836637

ValoRization of Dairy Sidestreams to Fight Calcium dEficits iN Postmenopausal Women

ValoRization of Dairy Sidestreams to Fight Calcium dEficits iN Postmenopausal Women - A Randomized Controlled Double-blinded Intervention Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 420 (actual)
• Sponsor: University of Copenhagen · Academic / Other
• Sex: Female
• Age: 45 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to investigate the effects of 12-months supplementation with calcium-enriched permeate, taken alone or in conjunction with inulin, on changes in markers of bone formation and resorption and in bone mass density (BMD) in apparently healthy postmenopausal women compared with calcium-carbonate or maltodextrin supplementation.

Detailed description

The study will include an information visit, a randomization visit, a month 3 visit and a final visit at month 12. Besides, two visits at month 6 and 9 for dispensing of trial products. Outcome parameters will be measured using blood samples obtained at the randomization visit, the month 3 visit and at the final visit at month 12. Outcome parameters will moreover be analyzed based on DXA scan obtained at the randomization visit and at the final visit at 12 months.

Conditions

• Osteoporosis, Postmenopausal

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Maltodextrin	Three capsules are to be consumed with one sachet dissolved in 200 ml. of water for breakfast and later for dinner resulting in a total of six capsules and two sachets via oral consumption daily.
DIETARY_SUPPLEMENT	Calcium-carbonate	Three capsules are to be consumed with one sachet dissolved in 200 ml. of water for breakfast and later for dinner resulting in a total of six capsules and two sachets via oral consumption daily.
DIETARY_SUPPLEMENT	Calcium-enriched permeate	Three capsules are to be consumed with one sachet dissolved in 200 ml. of water for breakfast and later for dinner resulting in a total of six capsules and two sachets via oral consumption daily.
DIETARY_SUPPLEMENT	Calcium-enriched permeate with Inulin	Three capsules are to be consumed with one sachet dissolved in 200 ml. of water for breakfast and later for dinner resulting in a total of six capsules and two sachets via oral consumption daily.

Timeline

• Start date: 2021-05-17
• Primary completion: 2023-07-04
• Completion: 2023-07-04
• First posted: 2021-04-08
• Last updated: 2023-10-06

Locations

2 sites across 1 country: Denmark