NCT06383117Completed
Understanding Effects of Calcium on the Gut-Bone Axis
Georgia Clinical and Translational Science Alliance (Georgia CTSA) - KL2 Scholar Award
Source: ClinicalTrials.gov · Last updated 25 Apr 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 14 (actual)
- First submitted
- 12 Apr 2024
- Start date
- 17 Oct 2023
- Primary completion date
- 23 Feb 2024
- Lead sponsor
- University of Georgia
- Diseases
- Obesity
- NCT number
- NCT06383117
What you commit to
- Study type: Interventional
- Participants enrolled: 14
- From 17 Oct 2023 to the primary completion date, 23 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Regularly takes any daily prescription medication
- People with a history of kidney stones or prior diagnosis of other kidney problems
Other illness
- Diagnosis with a medical condition known to impact bone health, nutritional status, activity levels, or food digestion, absorption, or metabolism
- Are allergic or unwilling to consume any of the following foods: wheat, gluten, peanuts
Age
- Less than 18 years of age
- Greater than 45 years of age
Other
- 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
- For females, peri-menopausal or post-menopausal
- Inability to swallow pill capsules
- 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)
Who the study is looking for
- Generally healthy
- Aged 18-45
- Speaks/reads English
Age in the registry: 18 years to 45 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Georgia Clinical and Translational Research Unit Coordinator of this site? Confirm its status | Athens | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.