Functional Yogurt Powder Effect on Bone Health Biomarkers (bonefoods)

December 10, 2015 updated by: Instituto de Investigación Hospital Universitario La Paz
The purpose of this study was to evaluate the therapeutic effect of a functional yogurt powder on menopausal, middle-aged women at high risk of osteoporosis. The functional yogurt powder containing Calcium, D, K, C vitamins, Zn, Mg, L-leucin and the Lactobacillus plantarum 3547 probiotic, was developed to benefit bone health and in the long term may contribute to the prevention of osteoporosis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Randomized, parallel, double-blind, placebo controlled clinical trial to evaluate the effect of a functional yogurt powder on bone health biomarkers in menopause, middle-aged women at high risk of osteoporosis.

78 volunteers will be recruited at the La Paz University Hospital of Madrid. Participants should meet the next inclusion criteria: being menopausal, aged between 50 and 65 years, IMC≥18.5 <35 Kg/m2 and having a diagnosis of osteopenia without pharmacological treatment (Volunteers without osteopenia diagnosis should meet two of the next: dairy intake under 2 servings a day, sedentary lifestyle and/or smokers of more than 5 cigarettes a day).

Participants will be randomized in two arms:

  1. Functional yogurt powder arm: they will receive over 24 weeks a daily serving of the functional yogurt powder containing Calcium, D, K, C vitamins, Zn, Mg, L-leucin and the Lactobacillus plantarum 3547 probiotic.
  2. Control yogurt powder arm: they will receive over 24 weeks a daily serving of the control yogurt powder (not enriched).

All participants will be advised to follow a healthy diet and practice physical activity.

Follow up will include 3 individualized visits and 4 group visits to check the product intake compliance and the tolerance to the product. The primary outcome, vitamin D level, will be measured at the beginning (basal condition) and at the end of the intervention (24 weeks). Other bone health biomarkers (Parathyroid hormone (PTH) calcium, phosphorus, calcitonin, osteocalcin, adrenocorticotropic hormone (ACTH),osteopontin, osteoprotegerin, sclerostin,the N-terminal telopeptide (NTx) and C-terminal telopeptide CTx) and safety issues (transaminases and creatinine) will be measured at the same time points (0 and 24 weeks).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
79

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28046
        • Hospital Universitairo La Paz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • With healthy weight, overweight or obesity type I (IMC ≥18.5 <35 Kg/m2);

  • With diagnosis of osteopenia without pharmacological treatment or that meet at least two of the following criteria:

    • Dairy intake under 2 servings daily in the last year
    • Sedentary lifestyle (measured with the International physical activity questionary IPAQ)
    • Smokers of more than 5 cigarettes daily
  • Signed informed consent.

Exclusion Criteria:

  • Severe diseases (hepatic, kidney, cancer…)
  • Renal failure (defined as serum creatinine level >200 mol/L)
  • Phosphate binding antacids (> 6 months a year)
  • Oral glucocorticoids (>5 mg/day of prednison equivalent in the last 8 months or a total dose of 2g of prednison equivalent in the last 12 months)
  • Local treatment with injectable glucocorticoids (>5 injections/year)
  • Treatment with inhaled glucocorticoids (>6months in the last year and more than 2 mg/day of prednison equivalent)
  • Previous or concomitant treatment for metabolic bone disease
  • Use of hormone replacement therapy (oral estrogen, estradiol vaginal ring, antiestrogen, progesterone)
  • Anabolic steroid use in the last 3 months or more than one in the last 6 months
  • Estradiol implants in the last 3 years
  • Isoflavan use in the last 6 months or more than once a month for the last 12 months
  • Calcitonin use in the last month or more than 1 month in the last 6 months
  • Concomitant use of nutritional supplements with silicon, horsetail extracts, bamboo, colloidal silicic acid or silanol derivatives in the last 6 months
  • Hyperparathyroidism and/or hyperthyroidism
  • Chronic intestinal disease (Gastritis, ulcerative colitis, irritable bowel disease, pseudomembranous colitis, inflammatory bowel disease, Crohn disease, etc)
  • Dementia, mental disease or diminished cognitive function
  • Mayor surgery in the last month or gastrointestinal surgery in the last 3 months
  • Prebiotic, probiotic ad/or symbiotic consumption, antioxidant supplements, supplements with omega 3, vitamins or minerals in the last 2 weeks prior to the start of the study
  • Participation in programs and / or drug use for weight control in the last 6 months
  • Alcohol consumption over 30g/day

  • Habitual laxative use and non acceptance in giving up its use during the study

    • Individuals using topic glucocorticoids can enter the trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Functional yogurt powder
This arm will receive one daily serving of the functional yogurt which is enriched in Calcium, D, K, C vitamins, Zn, Mg, L-leucin and the Lactobacillus plantarum 3547 probiotic
Dietary supplement: Functional yogurt powder

Once daily during 24 weeks, 150g of yogurt powder enriched with:

Calcium (mg) 501 D3 Vitamin (Colecalciferol) (μg(UI)) 6(240) K Vitamin (μg) 80 C Vitamin (mg) 100 Zinc (mg) 10,39 Magnesium (mg) 250,5 L-Leucin (g) 1 Lactobacillus plantarum 3547 (ufc) 1x10e10
Placebo Comparator: Control yogurt powder
This arm will receive one daily serving of the control yogurt which consists of a regular yogurt not enriched
Dietary supplement: Control yogurt powder
Once daily during 24 weeks, 150g of yogurt powder not enriched, isocaloric and with an equal macronutrient composition than the functional yogurt

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
changes in plasma 25(OH)D concentration
Time Frame: 0 and 24 weeks
0 and 24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from baseline Body composition by Dual-energy X-ray absorptiometry (DXA)
Time Frame: 0 and 24 weeks
0 and 24 weeks
Change from baseline calcium levels in blood
Time Frame: 0 and 24 weeks
0 and 24 weeks
Change from baseline Parathyroid hormone (PTH)
Time Frame: 0 and 24 weeks
0 and 24 weeks
Change from baseline adrenocorticotropic hormone (ACTH)
Time Frame: 0 and 24 weeks
0 and 24 weeks
Change from baseline Calcitonin
Time Frame: 0 and 24 weeks
0 and 24 weeks
Change from baseline osteocalcin
Time Frame: 0 and 24 weeks
0 and 24 weeks
Change from baseline Osteopontin
Time Frame: 0 and 24 weeks
0 and 24 weeks
Change from baseline Osteoprotegerin
Time Frame: 0 and 24 weeks
0 and 24 weeks
Change from baseline sclerostin
Time Frame: 0 and 24 weeks
0 and 24 weeks
Change from baseline phosphorus
Time Frame: 0 and 24 weeks
0 and 24 weeks
Change from baseline N-terminal telopeptide
Time Frame: 0 and 24 weeks
0 and 24 weeks
Change from baseline the C-terminal telopeptide
Time Frame: 0 and 24 weeks
0 and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Instituto de Investigación Hospital Universitario La Paz

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Carmen Gomez Candela, MD, PhD, Hospital Universitario La Paz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 14, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 14, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BONEFOODS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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