Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06383117 |
Other study ID # |
UL1TR002378 |
Secondary ID |
KL2TR002381 |
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 17, 2023 |
Est. completion date |
February 23, 2024 |
Study information
Verified date |
April 2024 |
Source |
University of Georgia |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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. 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.
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.