Symbiotic Yogurt, Calcium Absorption and Bone Health in Young Adult Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03420716
Recruitment Status : Completed
First Posted : February 2, 2018
Last Update Posted : February 2, 2018
Information provided by (Responsible Party):
Carmen Marino Donangelo, Universidad de la Republica

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.

Condition or disease Intervention/treatment
Osteoporosis Dietary Supplement: yogurt

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Type of yogurt fed is blind for participants and investigators
Primary Purpose: Prevention
Official Title: Effect of Regular Consumption of a Symbiotic Yogurt on Calcium Absorption and Bone Health in Young Adult Women
Actual Study Start Date : September 2014
Primary Completion Date : December 2015
Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium
U.S. FDA Resources

Arm Intervention/treatment
Experimental: functional yogurt
Participants are given the symbiotic yogurt daily (180 ml)
Dietary Supplement: yogurt
Experimental: control yogurt
Participants are given the control yogurt daily (180 ml)
Dietary Supplement: yogurt

Primary Outcome Measures :
  1. Change in calcium absorption [ Time Frame: Day 21 and Day 63 ]
    Fractional calcium absorption measured with stable isotopes

Secondary Outcome Measures :
  1. Serum 25(OH) vitamin D [ Time Frame: Day 1 ]
    Serum 25 (OH) vitamin D values expressed in nmol/liter

  2. Bone mineral content and bone mineral density [ Time Frame: Day 1 ]
    Bone mineral content and bone mineral density values expressed as Z scores.

  3. Dietary calcium intake [ Time Frame: Day 1 ]
    Values expressed in mg/d

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Responsible Party: Carmen Marino Donangelo, Professor, Universidad de la Republica Identifier: NCT03420716     History of Changes
Other Study ID Numbers: URepublica 01
First Posted: February 2, 2018    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Carmen Marino Donangelo, Universidad de la Republica:
functional foods
dairy foods
calcium absorption
prebiotics and probiotics
young women
bone health

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs