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

NCT03420716 | Completed

• 1 other identifier: URepublica 01
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoporosis

Keywords

functional foods; dairy foods; calcium absorption; prebiotics and probiotics; young women; bone health

Outcome Measures

Primary Outcomes (1)

• Change in calcium absorption

  Fractional calcium absorption measured with stable isotopes

  Day 21 and Day 63

Secondary Outcomes (3)

• Serum 25(OH) vitamin D

  Day 1

• Bone mineral content and bone mineral density

  Day 1

• Dietary calcium intake

  Day 1

Study Arms (2)

functional yogurt

EXPERIMENTAL

Participants are given the symbiotic yogurt daily (180 ml)

Dietary Supplement: yogurt

control yogurt

EXPERIMENTAL

Participants are given the control yogurt daily (180 ml)

Dietary Supplement: yogurt

Interventions

yogurt DIETARY_SUPPLEMENT

control yogurt; functional yogurt

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ages 18 to 35 years
• generally healthy

You may not qualify if:

• pregnancy/lactation
• BMI \<18,5 kg/m2
• BMI\> 29 kg/m2
• metabolic disorders, bone, liver or kidney disease that may affect calcium metabolism
• smoking

Sponsors & Collaborators

• Universidad de la Republica: lead

Related Publications (1)

• 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.

  PMID: 35411924 DERIVED

MeSH Terms

Conditions

Osteoporosis

Interventions

Yogurt

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cultured Milk Products; Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Fermented Foods; Dairy Products; Food; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Type of yogurt fed is blind for participants and investigators
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 3 weeks on symbiotic yogurt or control yogurt, with a 3 week wash out period in between. Type of yougurt consumed first is randomized.

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: February 5, 2018
• Study Start: September 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: February 5, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share