Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06383117
Status:
COMPLETED
Last Update Posted:
2024-04-25
First Post:
2024-04-12
Brief Title:
Understanding Effects of Calcium on the Gut-Bone Axis
Sponsor:
University of Georgia
Organization:
University of Georgia
Study Overview
Official Title:
Georgia Clinical and Translational Science Alliance Georgia CTSA - KL2 Scholar Award
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 wont 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
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 pillmeal 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 pills 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 UGAs 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 eg new medication this information will be used to guide interpretation of results and to determine whether sensitivity statistical analyses are warranted
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 pills 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 UGAs 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 eg new medication this information will be used to guide interpretation of results and to determine whether sensitivity statistical analyses are warranted
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| KL2TR002381 | NIH | None | httpsreporternihgovquickSearchKL2TR002381 |