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Functional Yogurt Powder Effect on Bone Health Biomarkers (bonefoods)

Primary Purpose

OSTEOPENIA

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Functional yogurt powder
Control yogurt powder
Sponsored by
Instituto de Investigación Hospital Universitario La Paz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for OSTEOPENIA focused on measuring woman osteopenia osteoporosis enriched calcium vit D yogurt

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitairo La Paz

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Functional yogurt powder

Control yogurt powder

Arm Description

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

This arm will receive one daily serving of the control yogurt which consists of a regular yogurt not enriched

Outcomes

Primary Outcome Measures

changes in plasma 25(OH)D concentration

Secondary Outcome Measures

Change from baseline Body composition by Dual-energy X-ray absorptiometry (DXA)
Change from baseline calcium levels in blood
Change from baseline Parathyroid hormone (PTH)
Change from baseline adrenocorticotropic hormone (ACTH)
Change from baseline Calcitonin
Change from baseline osteocalcin
Change from baseline Osteopontin
Change from baseline Osteoprotegerin
Change from baseline sclerostin
Change from baseline phosphorus
Change from baseline N-terminal telopeptide
Change from baseline the C-terminal telopeptide

Full Information

First Posted
December 10, 2015
Last Updated
December 10, 2015
Sponsor
Instituto de Investigación Hospital Universitario La Paz
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1. Study Identification

Unique Protocol Identification Number
NCT02629341
Brief Title
Functional Yogurt Powder Effect on Bone Health Biomarkers
Acronym
bonefoods
Official Title
Functional Yogurt Powder Effect on Bone Health Biomarkers
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Hospital Universitario La Paz

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
OSTEOPENIA
Keywords
woman osteopenia osteoporosis enriched calcium vit D yogurt

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Functional yogurt powder
Arm Type
Active Comparator
Arm Description
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
Arm Title
Control yogurt powder
Arm Type
Placebo Comparator
Arm Description
This arm will receive one daily serving of the control yogurt which consists of a regular yogurt not enriched
Intervention Type
Dietary Supplement
Intervention Name(s)
Functional yogurt powder
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Control yogurt powder
Intervention Description
Once daily during 24 weeks, 150g of yogurt powder not enriched, isocaloric and with an equal macronutrient composition than the functional yogurt
Primary Outcome Measure Information:
Title
changes in plasma 25(OH)D concentration
Time Frame
0 and 24 weeks
Secondary Outcome Measure Information:
Title
Change from baseline Body composition by Dual-energy X-ray absorptiometry (DXA)
Time Frame
0 and 24 weeks
Title
Change from baseline calcium levels in blood
Time Frame
0 and 24 weeks
Title
Change from baseline Parathyroid hormone (PTH)
Time Frame
0 and 24 weeks
Title
Change from baseline adrenocorticotropic hormone (ACTH)
Time Frame
0 and 24 weeks
Title
Change from baseline Calcitonin
Time Frame
0 and 24 weeks
Title
Change from baseline osteocalcin
Time Frame
0 and 24 weeks
Title
Change from baseline Osteopontin
Time Frame
0 and 24 weeks
Title
Change from baseline Osteoprotegerin
Time Frame
0 and 24 weeks
Title
Change from baseline sclerostin
Time Frame
0 and 24 weeks
Title
Change from baseline phosphorus
Time Frame
0 and 24 weeks
Title
Change from baseline N-terminal telopeptide
Time Frame
0 and 24 weeks
Title
Change from baseline the C-terminal telopeptide
Time Frame
0 and 24 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen Gomez Candela, MD, PhD
Organizational Affiliation
Hospital Universitario La Paz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitairo La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain

12. IPD Sharing Statement

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Functional Yogurt Powder Effect on Bone Health Biomarkers

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