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

Effect of Regular Consumption of a Symbiotic Yogurt on Calcium Absorption and Bone Health in Young Adult Women

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.

Study Overview

• Status: Completed
• Conditions: Osteoporosis
• Intervention / Treatment: 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
• Enrollment (Actual): 54
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in calcium absorption	Fractional calcium absorption measured with stable isotopes	Day 21 and Day 63

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum 25(OH) vitamin D	Serum 25 (OH) vitamin D values expressed in nmol/liter	Day 1
Bone mineral content and bone mineral density	Bone mineral content and bone mineral density values expressed as Z scores.	Day 1
Dietary calcium intake	Values expressed in mg/d	Day 1

Collaborators and Investigators

• Sponsor: Universidad de la Republica

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: January 12, 2018
• First Submitted That Met QC Criteria: February 1, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Actual): February 5, 2018
• Last Update Submitted That Met QC Criteria: February 1, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: bone health; calcium absorption; young women; functional foods; dairy foods; prebiotics and probiotics
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis
• Other Study ID Numbers: URepublica 01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No