Understanding Effects of Calcium on the Gut-Bone Axis

NCT06383117 | Completed

• 2 other identifiers: UL1TR002378KL2TR002381
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Healthy; Adult; Calcium; Bone Resorption; Endocrine; Obesity

Keywords

calcium; post-prandial; bone; GIP; GLP-1; CTX; P1NP; PTH; mixed meal tolerance test; MMTT; glucose; Vitamin D

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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

  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.

Other Outcomes (3)

• Difference in insulin area under the curve between calcium and placebo

  Area under the curve value during calcium arm compared to area under the curve value during placebo arm. Insulin area under the curve will be computed using insulin values from minutes -1, 30, 60, 90, 120, 180 during a mixed-meal test.

• Difference in glucose area under the curve between calcium and placebo

  Area under the curve value during calcium arm compared to area under the curve value during placebo arm. Glucose area under the curve will be computed using glucose values from minutes -1, 30, 60, 90, 120, 180 during a mixed-meal test.

• Difference in PTH (parathyroid hormone) area under the curve between calcium and placebo

  Area under the curve value during calcium arm compared to area under the curve value during placebo arm. PTH area under the curve will be computed using PTH values from minutes -1, 30, 120, 180 during a mixed-meal test.

Study Arms (2)

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.

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.

Dietary Supplement: Calcium carbonate; Dietary Supplement: Placebo Control

Interventions

Calcium carbonate DIETARY_SUPPLEMENT

2 capsules containing 600 mg of calcium carbonate each

Calcium carbonate, then placebo control; Placebo control, then calcium carbonate

Placebo Control DIETARY_SUPPLEMENT

2 capsules containing methylcellulose

Calcium carbonate, then placebo control; Placebo control, then calcium carbonate

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• University of Georgia: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

University of Georgia Clinical and Translational Research Unit

Athens, Georgia, 30606, United States

Location

MeSH Terms

Conditions

Bone Resorption; Obesity

Interventions

Calcium Carbonate

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals

Study Officials

• Joseph M Kindler, PhD

  University of Georgia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator, participants, team distributing pills blinded to treatment arm
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized placebo crossover trial

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: April 25, 2024
• Study Start: October 17, 2023
• Primary Completion: February 23, 2024
• Study Completion: February 23, 2024
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be made available upon reasonable request by one year after the results are published
• Access Criteria: Detailed request for data will be made directly to the Principal Investigator who will be responsible for reviewing and responding to requests.

Locations

US (1)