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NCT Number: NCT03420716

Symbiotic Yogurt, 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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Yogurt

Dietary Supplement

Primary outcomes

  1. Change in calcium absorption

    Time frame: Day 21 and Day 63

    Fractional calcium absorption measured with stable isotopes

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Universidad de la Republica

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Feb 5, 2018
Registry last updated
Feb 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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