NCT04836637

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

May 17, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2023

Completed
Last Updated

October 6, 2023

Status Verified

October 1, 2023

Enrollment Period

2.1 years

First QC Date

March 30, 2021

Last Update Submit

October 5, 2023

Conditions

Osteoporosis, Postmenopausal

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (4)

  • Changes in blood parameters of iPTH

    1 year

  • Changes in blood parameters of Vitamin D

    1 year

  • Changes in blood parameters of total calcium

    1 year

  • Changes in blood parameters of phosphate

    1 year

Other Outcomes (7)

  • Changes in BMI

    1 year

  • Changes in physical activity

    1 year

  • Changes in habitual dietary intake

    1 year

  • +4 more other outcomes

Study Arms (4)

Product with placebo (no calcium supplementation).

PLACEBO COMPARATOR

Maltodextrin with 0 mg calcium in capsules and sachets consumed orally daily for one year.

Dietary Supplement: Maltodextrin

Product with calcium-carbonate

ACTIVE COMPARATOR

800 mg calcium as calcium-carbonate in capsules and sachets consumed orally daily for one year.

Dietary Supplement: Calcium-carbonate

Product with calcium-enriched permeate "Capolac"

EXPERIMENTAL

800 mg of calcium from calcium-enriched permeate in capsules and sachets consumed orally daily for one year.

Dietary Supplement: Calcium-enriched permeate

Product with calcium-enriched permeate "Capolac" and Inulin

EXPERIMENTAL

800 mg of calcium from calcium-enriched permeate and 12 g inulin in capsules and sachets consumed orally daily for one year.

Dietary Supplement: Calcium-enriched permeate with Inulin

Interventions

MaltodextrinDIETARY_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.

Product with placebo (no calcium supplementation).
Calcium-carbonateDIETARY_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.

Product with calcium-carbonate
Calcium-enriched permeateDIETARY_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.

Also known as: Capolac
Product with calcium-enriched permeate "Capolac"
Calcium-enriched permeate with InulinDIETARY_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.

Also known as: Capolac Inulin
Product with calcium-enriched permeate "Capolac" and Inulin

Eligibility Criteria

Age45 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Copenhagen, Frederiksberg, Denmark

Location

Zealand University Hospital

Køge, 4600, Denmark

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

maltodextrinCalcium CarbonateInulin

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Calcium CompoundsInorganic ChemicalsCarbonatesCarbonic AcidCarbon Compounds, InorganicMineralsStarchGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesFructansPolysaccharides

Study Officials

  • Mette F Hitz, Doctor

    Zealand University Hospital, Køge

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 30, 2021

First Posted

April 8, 2021

Study Start

May 17, 2021

Primary Completion

July 4, 2023

Study Completion

July 4, 2023

Last Updated

October 6, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

The results will be analyzed and attempted published in international journals regardsless of whether the study leads to positive, negative or inconclusive results. The study protocol will be registered and made publicly avalailable at www.clinicaltrials.gov.

Locations

DK(2)