Understanding Effects of Calcium on the Gut-Bone Axis
Completed · Not applicable · Has a placebo group
Conditions studied: Healthy, Adult, Calcium, Bone Resorption, Endocrine; Obesity
In brief
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.
Key facts
- Study ID
- NCT06383117
- Run by
- University of Georgia
- People needed
- 14
- Starts
- 2023-10-17
- Expected to finish
- 2024-02-23
- Last updated by the study team
- 2024-04-25
Who can join
Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Generally healthy
- Aged 18-45
- Speaks/reads English
You may not qualify if…
- 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
- 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
Where it is running
- University of Georgia Clinical and Translational Research Unit — Athens, Georgia, United States
Full record on ClinicalTrials.gov
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