HealthyNCT06383117
Understanding Effects of Calcium on the Gut-Bone Axis
A study testing Calcium carbonate in people with Healthy and Adult, run by University of Georgia at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- What is being tested?
- Calcium carbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2023to 23 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Generally healthy
- Aged 18-45
- Speaks/reads English
Who cannot join
- Diagnosis with a medical condition known to impact bone health, nutritional status, activity levels, or food digestion, absorption, or metabolism
- Self-reported body mass index (BMI) that is either <18.5 or >29.9
- Self-reported body weight less than 115 lbs.
- Inability to swallow pill capsules
- Less than 18 years of age
- Greater than 45 years of age
Show all 15Show fewer
- For females, peri-menopausal or post-menopausal
- Are allergic or unwilling to consume any of the following foods: wheat, gluten, peanuts
- Inability to swallow pill capsules
- Regularly takes any daily prescription medication
- Females using any form of hormonal birth control
- Females with a non-normal or absent menstrual cycle (based on self-report)
- Females will be excluded if they are currently pregnant or breastfeeding (based on self-report)
- Females will be excluded if they gave birth to a child in the last year (based on self-report)
- People with a history of kidney stones or prior diagnosis of other kidney problems
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Georgia Clinical and Translational Research Unit
Athens, Georgia, 30606
About this study
Official title: Georgia Clinical and Translational Science Alliance (Georgia CTSA) - KL2 Scholar Award
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.
Read the detailed description
The investigators will enroll 13 healthy adults to complete a randomized crossover trial aimed at determining effects of calcium on post-prandial changes in bone metabolism. Each subject will complete two mixed meal tolerance tests (MMTTs) on two separate days, completed within 8 weeks of one another. During both MMTTs, subjects will consume an identical test meal that has a known amount of energy, macronutrients, and micronutrients. The meal will be provided by study staff. At the start of the test meal, subjects will take either a calcium or placebo pill that is provided by the study staff. Blood measurements will be acquired at time points relative to the start of the pill/meal ingestion, which is referred to as minute 0. Blood will be collected at several time points during the 3-hour post-prandial period. Blood will be assayed for measures such as biomarkers of bone metabolism, ionized calcium, and hormones. Changes in these measures during the post-prandial period will be compared between the two meals.
Randomization: After a subject is determined to be eligible for the study and is enrolled, they will be randomized to either group A or group B. Group randomization will dictate the order in which either the calcium or placebo supplement are taken (at either visit 1 or visit 2). The subject and study team will be blinded.
Visit number 1 and 2 will use identical study protocols and procedures, with the exception of the supplement (calcium vs. Placebo) that is provided based on randomization. Questionnaires will only be completed at visit 1 with the exception of a short questionnaire capturing any possible changes in health status between the two visits. Visit 2 will be held within 8 weeks after visit 1.
MMTT: Prior to the appointment, subjects will be instructed to not consume any food or drink, other than water. They will also be reminded to not consume gum, candy, coffee etc. prior to the appointment. The test includes consuming a test meal and having blood drawn over the course of 3 hours. Following a 9-hour overnight fast, participants will be asked to have blood drawn by a qualified and experienced phlebotomist or nurse who will follow standard sterile techniques. Participants will have one fasting blood draw measurement before consuming the supplement (calcium or placebo) and meal. Following this measurement, participants will be asked to consume the test pill(s) and meal (and 12oz water), in no more than 10 minutes. In total, 75 mL of blood will be collected during each experiment. Using standard serum tubes ("red top tubes") and tubes pre-treated with protease inhibitors, blood collection will be completed at time points relative to commencement of ingestion of the meal, which will be referred to as "minute 0." Blood will be collected at minutes -1, 10, 15, 20, 30, 60, 90, 120, and 180. At minutes 10, 15, and 20, 2 mL will be collected using tubes pre-treated with protease inhibitors. At minutes -1, 30, 60, 90, 120, and 180, 7 mL will be collected using red top tubes and tubes pre-treated with protease inhibitors. After each of the blood collection time points, including time point -1, an additional 3 mL will be collected as 'waste' to clear the blood collection line for subsequent collections. Following the final measurement, participants will be offered a snack. Food cannot be consumed during the test. The participant will be monitored by trained medical staff (phlebotomists or nurses). Following completion of the study, blood specimens will be shipped to other labs that the investigators regularly collaborate with, such as University of Pennsylvania Translational Core Laboratory or UGA's Cytometry Core or Athens-Piedmont medical center.
Questionnaires: A Health History questionnaire (HHQ) will be administered to determine fracture history, medication use, menstrual health (females), etc. A demographics questionnaire will gather information on race, ethnicity, and sex. The demographic questionnaire and HHQ will be administered at the first in-person lab visit. The International Physical Activity Questionnaire will be completed for subjective assessment of physical activity and sedentary behaviors. A Food Frequency Questionnaire will be administered to assess nutrition patterns. These questionnaires will be completed by the study participants on RedCap. At visit two, a short health questionnaire will be administered to assess if there were any health changes since visit 1. In our statistical analyses, the investigators will consider data on diet, physical activity, etc. as potential confounding variables, and the investigators will use them as covariates if necessary. Mainly, these data will be used for descriptive purposes. In the instance that a change in health status between visit 1 and 2 (e.g., new medication), this information will be used to guide interpretation of results and to determine whether 'sensitivity' statistical analyses are warranted.
- Conditions
- Healthy, Adult, Calcium, Bone Resorption, Endocrine; Obesity
- Being tested
- Calcium carbonate, Placebo Control
- Keywords
- calcium, post-prandial, bone, GIP, GLP-1, CTX, P1NP, PTH, mixed meal tolerance test, MMTT, glucose, Vitamin D
- Medical subject headings
- Bone Resorption, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium carbonateDietary supplement
2 capsules containing 600 mg of calcium carbonate each
Placebo ControlDietary supplement
2 capsules containing methylcellulose
| Study group | Role | What they receive |
|---|---|---|
| Placebo control, then calcium carbonate | Experimental | At visit 1, participants will be instructed to consume 2 capsules (containing the placebo: vegetable based cellulose) immediately before consuming a standardized meal. Within 8 weeks, at visit 2, participants will be instructed to consume 2 capsules (containing the calcium carbonate, 1200 mg total) immediately before consuming a standardized meal. Receives: Dietary Supplement: Calcium carbonate; Dietary Supplement: Placebo Control |
| Calcium carbonate, then placebo control | Experimental | At visit 1, participants will be instructed to consume 2 capsules (containing the calcium carbonate, 1200 mg total) immediately before consuming a standardized meal. Within 8 weeks, at visit 2, participants will be instructed to consume 2 capsules (containing the placebo: vegetable based cellulose) immediately before consuming a standardized meal. Receives: Dietary Supplement: Calcium carbonate; Dietary Supplement: Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in GIP (gastric inhibitory peptide) area under the curve between calcium and placebo
Comparison of GIP response to a mixed-meal test between calcium and placebo.
Measured: Area under the curve value during calcium arm compared to area under the curve value during placebo arm. GIP area under the curve will be computed using GIP values from minutes -1, 10, 15, 20, 30, 60, 90, 120, and 180 during a mixed-meal test.
Difference in GLP-1 (glucagon-like peptide 1) area under the curve between calcium and placebo
Comparison of GLP-1 response to a mixed-meal test between calcium and placebo.
Measured: Area under the curve value during calcium arm compared to area under the curve value during placebo arm. GLP-1 area under the curve will be computed using GLP-1 values from minutes -1, 10, 15, 20, 30, 60, 90, 120, and 180 during a mixed-meal test.
Secondary outcomes (2)
Difference in CTX (carboxy-terminal collagen crosslinks) area under the curve between calcium and placebo
Comparison of CTX response to a mixed-meal test between calcium and placebo.
Measured: Area under the curve value during calcium arm compared to area under the curve value during placebo arm. CTX area under the curve will be computed using CTX values from minutes -1, 30, 120, 180 during a mixed-meal test.
Difference in P1NP (N-terminal propeptide) area under the curve between calcium and placebo
Comparison of P1NP response to a mixed-meal test between calcium and placebo.
Measured: Area under the curve value during calcium arm compared to area under the curve value during placebo arm. P1NP area under the curve will be computed using P1NP values from minutes -1, 30, 120, 180 during a mixed-meal test.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start17 Oct 2023
- Primary completion23 Feb 2024
- Study completion23 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized placebo crossover trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Georgia
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Joseph Kindler, University of Georgia
- Investigators
- Joseph M Kindler, PhD, Principal investigator, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06383117
- Sponsor's protocol ID
- UL1TR002378
- Other IDs
- KL2TR002381
- Status last verified
- Apr 2024
- First submitted
- 12 Apr 2024
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD (individual participant data) that underlie results in a publication will be made available to other researchers upon reasonable request. The team will follow Institutional policies and procedures for data sharing, including appropriate approvals and complete de-identification of data and/or specimens.
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Georgia Clinical and Translational Science Alliance (Georgia CTSA) - KL2 Scholar Award
- ClinicalTrials.gov ID
- NCT06383117
- Acronym / sponsor ID
- UL1TR002378
- Conditions
- Healthy, Adult, Calcium, Bone Resorption, Endocrine; Obesity
- Keywords
- calcium, post-prandial, bone, GIP, GLP-1, CTX, P1NP, PTH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of GeorgiaUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- 23 Feb 2024 (actual)
- Study completion
- 23 Feb 2024 (actual)
- First posted
- 25 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators will enroll 13 healthy adults to complete a randomized crossover trial aimed at determining effects of calcium on post-prandial changes in bone metabolism. Each subject will complete two mixed meal tolerance tests (MMTTs) on two separate days, completed within 8 weeks of one another. During both MMTTs, subjects will consume an identical test meal that has a known amount of energy, macronutrients, and micronutrients. The meal will be provided by study staff. At the start of the test meal, subjects will take either a calcium or placebo pill that is provided by the study staff. Blood measurements will be acquired at time points relative to the start of the pill/meal ingestion, which is referred to as minute 0. Blood will be collected at several time points during the 3-hour post-prandial period. Blood will be assayed for measures such as biomarkers of bone metabolism, ionized calcium, and hormones. Changes in these measures during the post-prandial period will be compared between the two meals.
Randomization: After a subject is determined to be eligible for the study and is enrolled, they will be randomized to either group A or group B. Group randomization will dictate the order in which either the calcium or placebo supplement are taken (at either visit 1 or visit 2). The subject and study team will be blinded.
Visit number 1 and 2 will use identical study protocols and procedures, with the exception of the supplement (calcium vs. Placebo) that is provided based on randomization. Questionnaires will only be completed at visit 1 with the exception of a short questionnaire capturing any possible changes in health status between the two visits. Visit 2 will be held within 8 weeks after visit 1.
MMTT: Prior to the appointment, subjects will be instructed to not consume any food or drink, other than water. They will also be reminded to not consume gum, candy, coffee etc. prior to the appointment. The test includes consuming a test meal and having blood drawn over the course of 3 hours. Following a 9-hour overnight fast, participants will be asked to have blood drawn by a qualified and experienced phlebotomist or nurse who will follow standard sterile techniques. Participants will have one fasting blood draw measurement before consuming the supplement (calcium or placebo) and meal. Following this measurement, participants will be asked to consume the test pill(s) and meal (and 12oz water), in no more than 10 minutes. In total, 75 mL of blood will be collected during each experiment. Using standard serum tubes ("red top tubes") and tubes pre-treated with protease inhibitors, blood collection will be completed at time points relative to commencement of ingestion of the meal, which will be referred to as "minute 0." Blood will be collected at minutes -1, 10, 15, 20, 30, 60, 90, 120, and 180. At minutes 10, 15, and 20, 2 mL will be collected using tubes pre-treated with protease inhibitors. At minutes -1, 30, 60, 90, 120, and 180, 7 mL will be collected using red top tubes and tubes pre-treated with protease inhibitors. After each of the blood collection time points, including time point -1, an additional 3 mL will be collected as 'waste' to clear the blood collection line for subsequent collections. Following the final measurement, participants will be offered a snack. Food cannot be consumed during the test. The participant will be monitored by trained medical staff (phlebotomists or nurses). Following completion of the study, blood specimens will be shipped to other labs that the investigators regularly collaborate with, such as University of Pennsylvania Translational Core Laboratory or UGA's Cytometry Core or Athens-Piedmont medical center.
Questionnaires: A Health History questionnaire (HHQ) will be administered to determine fracture history, medication use, menstrual health (females), etc. A demographics questionnaire will gather information on race, ethnicity, and sex. The demographic questionnaire and HHQ will be administered at the first in-person lab visit. The International Physical Activity Questionnaire will be completed for subjective assessment of physical activity and sedentary behaviors. A Food Frequency Questionnaire will be administered to assess nutrition patterns. These questionnaires will be completed by the study participants on RedCap. At visit two, a short health questionnaire will be administered to assess if there were any health changes since visit 1. In our statistical analyses, the investigators will consider data on diet, physical activity, etc. as potential confounding variables, and the investigators will use them as covariates if necessary. Mainly, these data will be used for descriptive purposes. In the instance that a change in health status between visit 1 and 2 (e.g., new medication), this information will be used to guide interpretation of results and to determine whether 'sensitivity' statistical analyses are warranted.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized placebo crossover trial
| Arm | Type | Receives |
|---|---|---|
| Placebo control, then calcium carbonate | Experimental | Dietary Supplement: Calcium carbonate, Dietary Supplement: Placebo ControlAt visit 1, participants will be instructed to consume 2 capsules (containing the placebo: vegetable based cellulose) immediately before consuming a standardized meal. Within 8 weeks, at visit 2, participants will be instructed to consume 2 capsules (containing the calcium carbonate, 1200 mg total) immediately before consuming a standardized meal. |
| Calcium carbonate, then placebo control | Experimental | Dietary Supplement: Calcium carbonate, Dietary Supplement: Placebo ControlAt visit 1, participants will be instructed to consume 2 capsules (containing the calcium carbonate, 1200 mg total) immediately before consuming a standardized meal. Within 8 weeks, at visit 2, participants will be instructed to consume 2 capsules (containing the placebo: vegetable based cellulose) immediately before consuming a standardized meal. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Generally healthy
- Aged 18-45
- Speaks/reads English
Key exclusion criteria (15 listed)
- Diagnosis with a medical condition known to impact bone health, nutritional status, activity levels, or food digestion, absorption, or metabolism
- Self-reported body mass index (BMI) that is either <18.5 or >29.9
- Self-reported body weight less than 115 lbs.
- Inability to swallow pill capsules
- Less than 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium carbonate2 capsules containing 600 mg of calcium carbonate each | Dietary supplement | Calcium carbonate, then placebo control, Placebo control, then calcium carbonate |
| Placebo Control2 capsules containing methylcellulose | Dietary supplement | Calcium carbonate, then placebo control, Placebo control, then calcium carbonate |
Primary outcome
Difference in GIP (gastric inhibitory peptide) area under the curve between calcium and placebo
Time frame: Area under the curve value during calcium arm compared to area under the curve value during placebo arm. GIP area under the curve will be computed using GIP values from minutes -1, 10, 15, 20, 30, 60, 90, 120, and 180 during a mixed-meal test.
Comparison of GIP response to a mixed-meal test between calcium and placebo.
Difference in GLP-1 (glucagon-like peptide 1) area under the curve between calcium and placebo
Time frame: Area under the curve value during calcium arm compared to area under the curve value during placebo arm. GLP-1 area under the curve will be computed using GLP-1 values from minutes -1, 10, 15, 20, 30, 60, 90, 120, and 180 during a mixed-meal test.
Comparison of GLP-1 response to a mixed-meal test between calcium and placebo.
2 secondary outcomes
Difference in CTX (carboxy-terminal collagen crosslinks) area under the curve between calcium and placebo
Time frame: Area under the curve value during calcium arm compared to area under the curve value during placebo arm. CTX area under the curve will be computed using CTX values from minutes -1, 30, 120, 180 during a mixed-meal test.
Difference in P1NP (N-terminal propeptide) area under the curve between calcium and placebo
Time frame: Area under the curve value during calcium arm compared to area under the curve value during placebo arm. P1NP area under the curve will be computed using P1NP values from minutes -1, 30, 120, 180 during a mixed-meal test.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Individual participant dataSharing planned: Yes. All IPD (individual participant data) that underlie results in a publication will be made available to other researchers upon reasonable request. The team will follow Institutional policies and procedures for data sharing, including appropriate approvals and complete de-identification of data and/or specimens.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph M Kindler, PhD principal investigator
University of Georgia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium carbonate in people with Healthy and Adult, run by University of Georgia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in GIP (gastric inhibitory peptide) area under the curve between calcium and placebo (time frame: Area under the curve value during calcium arm compared to area under the curve value during placebo arm. GIP area under the curve will be computed using GIP values from minutes -1, 10, 15, 20, 30, 60, 90, 120, and 180 during a mixed-meal test.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.