protocolSection identificationModule nctId: NCT06383117, orgStudyIdInfo id: UL1TR002378, type: NIH, link: https://reporter.nih.gov/quickSearch/UL1TR002378, secondaryIdInfos id: KL2TR002381, type: NIH, link: https://reporter.nih.gov/quickSearch/KL2TR002381, briefTitle: Understanding Effects of Calcium on the Gut-Bone Axis, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-10-17, primaryCompletionDateStruct date: 2024-02-23, completionDateStruct date: 2024-02-23, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: University of Georgia, class: OTHER, collaborators name: National Center for Advancing Translational Sciences (NCATS), descriptionModule briefSummary: The study team is inviting 13 healthy people to complete a study to explore how calcium affects hormones and bones after eating. Participants will be asked to complete two study visits within eight weeks. Before each visit, participants will be asked to not eat or drink (except water) for 9 hours. At each visit, participants will eat the same meal provided by the research team. Along with their meal, they will take a pill - in one session, this will be a calcium supplement, and in the other, a placebo (a pill with no calcium), but they won't know which one they are taking at which session. A phlebotomist will draw blood before the meal and pill, then again several times after eating. Blood draws will take place over three hours. During that time, participants will complete questionnaires about health, diet, and physical activity.Blood will be analyzed to check on various health indicators, like bone health markers and certain hormones, to see how they change after the meal. The difference in these health indicators between the calcium and placebo sessions will help the study team understand the impact of calcium on health after eating. This could help increase knowledge of the impact of calcium on hormones and bone health., conditionsModule conditions: Healthy, conditions: Adult, conditions: Calcium, conditions: Bone Resorption, conditions: Endocrine; Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Randomized placebo crossover trial, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, maskingDescription: Investigator, participants, team distributing pills blinded to treatment arm, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 14, type: ACTUAL, armsInterventionsModule interventions name: Calcium carbonate, interventions name: Placebo Control, outcomesModule primaryOutcomes measure: Difference in GIP (gastric inhibitory peptide) area under the curve between calcium and placebo, primaryOutcomes measure: Difference in GLP-1 (glucagon-like peptide 1) area under the curve between calcium and placebo, secondaryOutcomes measure: Difference in CTX (carboxy-terminal collagen crosslinks) area under the curve between calcium and placebo, secondaryOutcomes measure: Difference in P1NP (N-terminal propeptide) area under the curve between calcium and placebo, otherOutcomes measure: Difference in insulin area under the curve between calcium and placebo, otherOutcomes measure: Difference in glucose area under the curve between calcium and placebo, otherOutcomes measure: Difference in PTH (parathyroid hormone) area under the curve between calcium and placebo, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Georgia Clinical and Translational Research Unit, city: Athens, state: Georgia, zip: 30606, country: United States, geoPoint lat: 33.96095, lon: -83.37794, hasResults: False