Maltodextrin
Dietary SupplementThree 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.
NCT Number: NCT04836637
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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Notify Me45 year–75 year
Female
Interventional
Not applicable
Copenhagen University, Department of Nutrition, Exercise and Sports, Section for Clinical and Preventive Nutrition, Copenhagen, Frederiksberg, Denmark
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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
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
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)
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)
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)
Time frame: 1 year
Changes in fasting blood samples of iPTH attained at randomization and 12 months visit (final visit)
Time frame: 1 year
Changes in fasting blood samples of vitamin D attained at randomization and 12 months visit (final visit)
Time frame: 1 year
Changes in fasting blood samples of total calcium attained at randomization and 12 months visit (final visit)
Time frame: 1 year
Changes in fasting blood samples of phosphate attained at randomization and 12 months visit (final visit)
Time frame: 1 year
Changes in BMI from randomization to 12 months visit (final visit)
Time frame: 1 year
Changes in physical activity level attained by IPAQ from randomization to 12 months visit (final visit)
Time frame: 1 year
Changes in habitual dietary intake attained by Myfood24 7-day recording from randomization to 12 months visit (final visit)
Time frame: 1 year
Changes in fecal pH from randomization to 12 months visit (final visit)
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)
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.
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.
University of Copenhagen
Other
ValoRization of Dairy Sidestreams to Fight Calcium dEficits iN Postmenopausal Women - A Randomized Controlled Double-blinded Intervention Trial
Acronym: RENEW
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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