Effects of Liposomal Encapsulation on Calcium Powder Absorption and Metabolism

Osteoporosis Clinical Trial

Official title:

Effects of Liposomal Encapsulation on Calcium Powder Absorption and Metabolism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06372158
• Other study ID #: NYCU112181AE
• Status: Recruiting
• Phase: N/A
• Start date: April 8, 2024
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: National Yang Ming University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Compared with traditional calcium supplements, liposome calcium can increase the bioavailability of calcium and reduce the waste caused by gastric acid destruction of calcium. This allows calcium to be released slowly in the intestines, reducing the risk of indigestion or other side effects caused by excessive intake at one time. Liposomal calcium can be taken orally directly. It does not need to be dissolved in water before taking like other calcium supplements, making it more convenient to use. Based on the above advantages, liposomal calcium is a relatively safe and easy-to-absorb calcium supplement, suitable for long-term use, and can meet the body's demand for calcium. According to the recommendations of the World Health Organization, the daily calcium intake for adults should be 1000-1300 mg. In Taiwan, the seventh edition of the revised reference intake of dietary nutrients for Chinese people recommends that the daily intake for adults should be 1,000 mg. The calcium dose used in this study was 500 mg. The purpose was to explore whether the sustained-release characteristics of liposome coating technology can improve the absorption rate after consuming calcium powder and achieve better bioavailability. It is expected that microlipids made by lecithin can Lipid calcium powder increases its maintenance time in the blood, thereby increasing the supplementary effect of calcium, and is an alternative to calcium supplements.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• Adults aged 20-60 years old, without heart, liver, kidney, endocrine or major organic diseases (patient report), and able to fully cooperate with the experiment.

Exclusion Criteria:

1. Patients with renal insufficiency and dialysis

2. Cancer patients

3. Underweight (BMI#17) or obese (BMI#27)

4. Those taking medications for chronic diseases

5. Blood pressure systolic blood pressure # 130 mmHg or diastolic blood pressure # 85 mmHg

6. Fasting blood glucose # 100 mg/dL

7. Fasting triglycerides # 150 mg/dL, total cholesterol # 200 mg/dL

8. Have a history of vitamin C allergy

9. People suffering from mental illness

10. Pregnant and breastfeeding women

11. Patients with hemosiderosis

12. Kidney stone patients

13. Supplements for those who take calcium for a long time

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Dietary Supplement:
• Stage 1
Number 1-10 :General vitamin C powder group (Contains 1500 mg Ca); Number 11-20: liposomal encapsulation Ca powder group (Contains 1500 mg of Ca and lecithin and is coated)
• Stage 2
Number 11-20 :General vitamin C powder group (Contains 1500 mg Ca); Number 1-10: liposomal encapsulation Ca powder group (Contains 1500 mg of Ca and lecithin and is coated)

Locations

Country	Name	City	State
Taiwan	National Yang Ming Chiao Tung University	Taipei	Beitou Dist.
Taiwan	National Yang Ming Chiao Tung University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	General examination	BMI(Body Mass Index is a simple calculation using a person's height and weight. The formula is BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared) and blood pressure	Day 14 and 28
Primary	Hematology Test	Fasting blood glucose, triglycerides, total cholesterol, Blood urea nitrogen, Creatinine(Blood urea nitrogen (BUN) and creatinine tests can be used together to find the BUN-to-creatinine ratio (BUN:creatinine). A BUN-to-creatinine ratio can help your doctor check for problems, such as dehydration, that may cause abnormal BUN and creatinine levels.), GOT, GPT	Day 14 and 28