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Completed

NCT Number: NCT04836637

ValoRization of Dairy Sidestreams to Fight Calcium dEficits iN Postmenopausal Women

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.

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Key information

Age range

45 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Copenhagen University, Department of Nutrition, Exercise and Sports, Section for Clinical and Preventive Nutrition, Copenhagen, Frederiksberg, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Maltodextrin

Dietary Supplement

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

Dietary Supplement

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

Dietary Supplement

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.

Other names: Capolac

Calcium-enriched permeate with Inulin

Dietary Supplement

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.

Other names: Capolac Inulin

Primary outcomes

  1. The change in bone turnover marker CTX.

    Time frame: 1 year

    Changes in fasting blood samples of bone turnover marker CTX attained at randomization, 3 months visit and 12 months visit (final visit)

  2. The change in bone turnover marker P1NP.

    Time frame: 1 year

    Changes in fasting blood samples of bone turnover marker (P1NP) attained at randomization, 3 months visit and 12 months visit (final visit)

  3. The change in loss of bone mineral density.

    Time frame: 1 year

    Changes in DXA scan results of BMD (femur) and BMD (lumbar spine) attained at randomization and 12 months visit (final visit)

Secondary outcomes

  1. Changes in blood parameters of iPTH

    Time frame: 1 year

    Changes in fasting blood samples of iPTH attained at randomization and 12 months visit (final visit)

  2. Changes in blood parameters of Vitamin D

    Time frame: 1 year

    Changes in fasting blood samples of vitamin D attained at randomization and 12 months visit (final visit)

  3. Changes in blood parameters of total calcium

    Time frame: 1 year

    Changes in fasting blood samples of total calcium attained at randomization and 12 months visit (final visit)

  4. Changes in blood parameters of phosphate

    Time frame: 1 year

    Changes in fasting blood samples of phosphate attained at randomization and 12 months visit (final visit)

Other outcomes

  1. Changes in BMI

    Time frame: 1 year

    Changes in BMI from randomization to 12 months visit (final visit)

  2. Changes in physical activity

    Time frame: 1 year

    Changes in physical activity level attained by IPAQ from randomization to 12 months visit (final visit)

  3. Changes in habitual dietary intake

    Time frame: 1 year

    Changes in habitual dietary intake attained by Myfood24 7-day recording from randomization to 12 months visit (final visit)

  4. Changes in fecal pH

    Time frame: 1 year

    Changes in fecal pH from randomization to 12 months visit (final visit)

  5. Changes in gut microbiome

    Time frame: 1 year

    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)

  6. Changes in urinary metabolites

    Time frame: 1 year

    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.

  7. Changes in fecal metabolites

    Time frame: 1 year

    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.

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Zealand University Hospital

Registry information

Official study title

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

Acronym: RENEW

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 8, 2021
Registry last updated
Oct 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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