An interventional study of yogurt in Osteoporosis, sponsored by Universidad de la Republica. Completed. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-05.
Sponsored by Universidad de la Republica · Not applicable, Interventional, and Prevention
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.
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.
Exclusion Criteria:
Participants are given the symbiotic yogurt daily (180 ml)
Dietary Supplement: yogurt
Participants are given the control yogurt daily (180 ml)
Dietary Supplement: yogurt
Change in calcium absorption
Fractional calcium absorption measured with stable isotopes
Time frame: Day 21 and Day 63
Serum 25(OH) vitamin D
Serum 25 (OH) vitamin D values expressed in nmol/liter
Time frame: Day 1
Bone mineral content and bone mineral density
Bone mineral content and bone mineral density values expressed as Z scores.
Time frame: Day 1
Dietary calcium intake
Values expressed in mg/d
Time frame: Day 1
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Universidad de la Republica