Symbiotic Yogurt, Calcium Absorption and Bone Health in Young Adult Women
Primary Purpose
Osteoporosis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
yogurt
Sponsored by
About this trial
This is an interventional prevention trial for Osteoporosis focused on measuring functional foods, dairy foods, calcium absorption, prebiotics and probiotics, young women, bone health
Eligibility Criteria
Inclusion Criteria:
- ages 18 to 35 years
- generally healthy
Exclusion Criteria:
- pregnancy/lactation
- BMI <18,5 kg/m2
- BMI> 29 kg/m2
- metabolic disorders, bone, liver or kidney disease that may affect calcium metabolism
- smoking
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
functional yogurt
control yogurt
Arm Description
Participants are given the symbiotic yogurt daily (180 ml)
Participants are given the control yogurt daily (180 ml)
Outcomes
Primary Outcome Measures
Change in calcium absorption
Fractional calcium absorption measured with stable isotopes
Secondary Outcome Measures
Serum 25(OH) vitamin D
Serum 25 (OH) vitamin D values expressed in nmol/liter
Bone mineral content and bone mineral density
Bone mineral content and bone mineral density values expressed as Z scores.
Dietary calcium intake
Values expressed in mg/d
Full Information
NCT ID
NCT03420716
First Posted
January 12, 2018
Last Updated
February 1, 2018
Sponsor
Universidad de la Republica
1. Study Identification
Unique Protocol Identification Number
NCT03420716
Brief Title
Symbiotic Yogurt, Calcium Absorption and Bone Health in Young Adult Women
Official Title
Effect of Regular Consumption of a Symbiotic Yogurt on Calcium Absorption and Bone Health in Young Adult Women
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de la Republica
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Prebiotics have been linked to increased calcium absorption in animal and human studies (particularly in adolescents and in premenopausal women). Similarly, probiotics have been found to benefit calcium homeostasis in pregnant women, and to promote bio-mineralization in animal models. The effect of symbiotic on calcium absorption has been tested in rats, but not in human studies. The primary objective of this study is to investigate the effect of daily consumption of a functional symbiotic yogurt containing inulin and Lactobacillus rhamnosus compared to a control yogurt, on calcium absorption in young adult women. A secondary objective is to relate changes in calcium absorption following yogurt consumption, with calcium metabolism, vitamin D status, bone mass, calcium intake and overall composition of habitual diet.
Detailed Description
A potential strategy to reduce the risk of osteoporosis later in life is to promote optimal bone mass during early adulthood by including in the diet functional foods that maximize the efficiency of calcium absorption. This approach is specially important in women because of their greater risk for osteoporosis than men. In this study, we hypothesized that the daily consumption of a yogurt containing inulin and Lactobacillus rhamnosus (symbiotic yogurt) increases the efficiency of calcium absorption in young adult women when compared to daily consumption of a yogurt of similar composition but without prebiotic or probiotic (control yogurt). Subjects in this study will be randomly assigned to consume daily the symbiotic yogurt or the control yogurt during two 3-week periods with a wash-out period of 3-weeks, in a cross-over design. Calcium absorption will be measured by stable calcium isotope methodology. Bone mass (BMD, BMC) will be measured by dual-Y ray absorptiometry. Serum intact parathyroid hormone, 25-hydroxyvitamin D and dietary intake will be measured by conventional methods.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
functional foods, dairy foods, calcium absorption, prebiotics and probiotics, young women, bone health
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
3 weeks on symbiotic yogurt or control yogurt, with a 3 week wash out period in between. Type of yougurt consumed first is randomized.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Type of yogurt fed is blind for participants and investigators
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
functional yogurt
Arm Type
Experimental
Arm Description
Participants are given the symbiotic yogurt daily (180 ml)
Arm Title
control yogurt
Arm Type
Experimental
Arm Description
Participants are given the control yogurt daily (180 ml)
Intervention Type
Dietary Supplement
Intervention Name(s)
yogurt
Primary Outcome Measure Information:
Title
Change in calcium absorption
Description
Fractional calcium absorption measured with stable isotopes
Time Frame
Day 21 and Day 63
Secondary Outcome Measure Information:
Title
Serum 25(OH) vitamin D
Description
Serum 25 (OH) vitamin D values expressed in nmol/liter
Time Frame
Day 1
Title
Bone mineral content and bone mineral density
Description
Bone mineral content and bone mineral density values expressed as Z scores.
Time Frame
Day 1
Title
Dietary calcium intake
Description
Values expressed in mg/d
Time Frame
Day 1
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
ages 18 to 35 years
generally healthy
Exclusion Criteria:
pregnancy/lactation
BMI <18,5 kg/m2
BMI> 29 kg/m2
metabolic disorders, bone, liver or kidney disease that may affect calcium metabolism
smoking
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35411924
Citation
Cornes R, Sintes C, Pena A, Albin S, O'Brien KO, Abrams SA, Donangelo CM. Daily Intake of a Functional Synbiotic Yogurt Increases Calcium Absorption in Young Adult Women. J Nutr. 2022 Jul 6;152(7):1647-1654. doi: 10.1093/jn/nxac088.
Results Reference
derived
Learn more about this trial
Symbiotic Yogurt, Calcium Absorption and Bone Health in Young Adult Women
We'll reach out to this number within 24 hrs