OSTEOPENIAPhase 3bonefoodsNCT02629341
Functional Yogurt Powder Effect on Bone Health Biomarkers
A Phase 3 study testing Functional yogurt powder in people with OSTEOPENIA, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 50 to 65 years, women only
- Conditions the study is for
- OSTEOPENIA
- What is being tested?
- Functional yogurt powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2015to Jul 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- 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.
- 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).
- Conditions
- OSTEOPENIA
- Being tested
- Functional yogurt powder, Control yogurt powder
- Keywords
- woman osteopenia osteoporosis enriched calcium vit D yogurt
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional yogurt powderDietary supplement
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
Control yogurt powderDietary supplement
Once daily during 24 weeks, 150g of yogurt powder not enriched, isocaloric and with an equal macronutrient composition than the functional yogurt
| Study group | Role | What they receive |
|---|---|---|
| Functional yogurt powder | Active comparator | 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 Receives: Dietary Supplement: Functional yogurt powder |
| Control yogurt powder | Placebo comparator | This arm will receive one daily serving of the control yogurt which consists of a regular yogurt not enriched Receives: Dietary Supplement: Control yogurt powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in plasma 25(OH)D concentration
Measured: 0 and 24 weeks
Secondary outcomes (12)
Change from baseline Body composition by Dual-energy X-ray absorptiometry (DXA)
Measured: 0 and 24 weeks
Change from baseline calcium levels in blood
Measured: 0 and 24 weeks
Change from baseline Parathyroid hormone (PTH)
Measured: 0 and 24 weeks
Change from baseline adrenocorticotropic hormone (ACTH)
Measured: 0 and 24 weeks
Change from baseline Calcitonin
Measured: 0 and 24 weeks
Change from baseline osteocalcin
Measured: 0 and 24 weeks
Change from baseline Osteopontin
Measured: 0 and 24 weeks
Change from baseline Osteoprotegerin
Measured: 0 and 24 weeks
Change from baseline sclerostin
Measured: 0 and 24 weeks
Change from baseline phosphorus
Measured: 0 and 24 weeks
Change from baseline N-terminal telopeptide
Measured: 0 and 24 weeks
Change from baseline the C-terminal telopeptide
Measured: 0 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2015 (estimated)
- Study startJan 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OSTEOPENIAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carmen Gomez Candela, MD, PhD, Principal investigator, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02629341
- Sponsor's protocol ID
- BONEFOODS
- Acronym
- bonefoods
- Status last verified
- Dec 2015
- First submitted
- 10 Dec 2015
- Last updated
- 14 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Yogurt Powder Effect on Bone Health Biomarkers
- ClinicalTrials.gov ID
- NCT02629341
- Acronym / sponsor ID
- bonefoods / BONEFOODS
- Conditions
- OSTEOPENIA
- Keywords
- woman osteopenia osteoporosis enriched calcium vit D yogurt
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 14 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional yogurt powder | Active comparator | Dietary Supplement: Functional yogurt powderThis 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 |
| Control yogurt powder | Placebo comparator | Dietary Supplement: Control yogurt powderThis arm will receive one daily serving of the control yogurt which consists of a regular yogurt not enriched |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
- Signed informed consent.
Key exclusion criteria (22 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional yogurt powderOnce 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 | Dietary supplement | Functional yogurt powder |
| Control yogurt powderOnce daily during 24 weeks, 150g of yogurt powder not enriched, isocaloric and with an equal macronutrient composition than the functional yogurt | Dietary supplement | Control yogurt powder |
Primary outcome
changes in plasma 25(OH)D concentration
Time frame: 0 and 24 weeks
12 secondary outcomes
Change from baseline Body composition by Dual-energy X-ray absorptiometry (DXA)
Time frame: 0 and 24 weeks
Change from baseline calcium levels in blood
Time frame: 0 and 24 weeks
Change from baseline Parathyroid hormone (PTH)
Time frame: 0 and 24 weeks
Change from baseline adrenocorticotropic hormone (ACTH)
Time frame: 0 and 24 weeks
Change from baseline Calcitonin
Time frame: 0 and 24 weeks
Change from baseline osteocalcin
Time frame: 0 and 24 weeks
Change from baseline Osteopontin
Time frame: 0 and 24 weeks
Change from baseline Osteoprotegerin
Time frame: 0 and 24 weeks
Change from baseline sclerostin
Time frame: 0 and 24 weeks
Change from baseline phosphorus
Time frame: 0 and 24 weeks
Change from baseline N-terminal telopeptide
Time frame: 0 and 24 weeks
Change from baseline the C-terminal telopeptide
Time frame: 0 and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
Related trials for OSTEOPENIA
Not yet recruitingPhase 2
Melatonin in Posterior Mandible Extraction Socket
Bone Loss
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
Active, not recruiting
AI-Supported Mobile High-Impact and Strengthening Exercise Program in Postmenopausal Women With Low Bone Density
Osteopenia
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
RecruitingObservational study
Observational Study of Bone Complications in People With Post-menopausal Breast Cancer Who Have Stopped Treatment With Denosumab and Aromatase Inhibitors
Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen Gomez Candela, MD, PhD principal investigator
Hospital Universitario La Paz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Functional yogurt powder in people with OSTEOPENIA, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in plasma 25(OH)D concentration (time frame: 0 and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2015.