ValoRization of Dairy Sidestreams to Fight Calcium dEficits iN Postmenopausal Women

Osteoporosis, Postmenopausal Clinical Trial

— RENEW  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04836637
• Other study ID #: M236
• Status: Completed
• Phase: N/A
• Start date: May 17, 2021
• Est. completion date: July 4, 2023

Study information

• Verified date: October 2023
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: July 4, 2023
• Est. primary completion date: July 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

• Subject is between 45 years and 65 years of age by the time of inclusion.

• Subject has been menopausal for at least 1 year, defined as 12 months after last bleeding and up to 10 years.

• Subject is Caucasian.

• Has a BMI below 35.0.

• Holder of a computer.

• Has a sufficient vitamin D status (plasma 25OHD concentration > 50 nmol/L).

• Subject is willing and able to provide written informed consent prior to participation.

Exclusion Criteria:

• Subject taking supplements or medicine that affects calcium and bone metabolism e.g. diuretics or hormone replacement therapy evaluated by the investigator.

• Intake of antibiotics in the last 3 months before enrollment.

• Subject with an osteoporosis diagnosis or history of osteoporotic fractures.

• Presence of renal, gastrointestinal, hepatic or endocrinological diseases.

• Subject with any serious illness or history of cancer within the past 5 years (except adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer).

• Known or suspected abuse of alcohol or recreational drugs.

• Known milk allergy.

• Known or suspected hypersensitivity to trial products or related products.

• Blood donation except from the donation in this study.

• Subject where it is not possible to obtain sufficient data.

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Denmark	Copenhagen University, Department of Nutrition, Exercise and Sports, Section for Clinical and Preventive Nutrition	Copenhagen	Frederiksberg
Denmark	Zealand University Hospital	Køge

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in BMI	Changes in BMI from randomization to 12 months visit (final visit)	1 year
Other	Changes in physical activity	Changes in physical activity level attained by IPAQ from randomization to 12 months visit (final visit)	1 year
Other	Changes in habitual dietary intake	Changes in habitual dietary intake attained by Myfood24 7-day recording from randomization to 12 months visit (final visit)	1 year
Other	Changes in fecal pH	Changes in fecal pH from randomization to 12 months visit (final visit)	1 year
Other	Changes in gut microbiome	Changes in microbial taxonomy and microbial gene content measured via sequencing of DNA extracted from fecal samples from randomization to 12 months visit (final visit)	1 year
Other	Changes in urinary metabolites	Changes in urine metabolites from randomization to 12 months visit (final visit) by NMR spectroscopy to detect and quantify about 50 metabolites including creatinine, amines, amino acids, alcohols, carboxylic acids including short-chain fatty acids, keto acids, purine, pyridine and pyrimidine derivatives, sugars and derivatives.	1 year
Other	Changes in fecal metabolites	Changes in fecal metabolites from randomization to 12 months visit (final visit) by NMR spectroscopy to detect and quantify about 50 metabolites including creatine, creatinine, amines, amino acids, carboxylic acids including short-chain fatty acids, keto acids, nucleotides and derivatives.	1 year
Primary	The change in bone turnover marker CTX.	Changes in fasting blood samples of bone turnover marker CTX attained at randomization, 3 months visit and 12 months visit (final visit)	1 year
Primary	The change in bone turnover marker P1NP.	Changes in fasting blood samples of bone turnover marker (P1NP) attained at randomization, 3 months visit and 12 months visit (final visit)	1 year
Primary	The change in loss of bone mineral density.	Changes in DXA scan results of BMD (femur) and BMD (lumbar spine) attained at randomization and 12 months visit (final visit)	1 year
Secondary	Changes in blood parameters of iPTH	Changes in fasting blood samples of iPTH attained at randomization and 12 months visit (final visit)	1 year
Secondary	Changes in blood parameters of Vitamin D	Changes in fasting blood samples of vitamin D attained at randomization and 12 months visit (final visit)	1 year
Secondary	Changes in blood parameters of total calcium	Changes in fasting blood samples of total calcium attained at randomization and 12 months visit (final visit)	1 year
Secondary	Changes in blood parameters of phosphate	Changes in fasting blood samples of phosphate attained at randomization and 12 months visit (final visit)	1 year