Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2025-12-25 @ 3:33 AM
NCT ID:
NCT04651205
Eligibility Criteria:
Inclusion Criteria:
1. aged 18 years and older
2. have been following LCHF diets for at least 2 months
3. carbohydrate intake is less than 130 g/day or less than 26% of energy intake
4. have stable body weight (weight change ≤ 2 kg within two months period)
5. no diagnosed or suspected eating disorder.
Exclusion Criteria:
1. currently taking Mg and B1 supplements within the last 3 months
2. underweight defined by BMI below 18.5 kg/m2
3. have been diagnosed with T1DM or other types of diabetes apart from T2DM.
4. if potential participants have been diagnosed with T2DM, they will be excluded if they are on anti-diabetic drugs and/or insulin (see 7.) or if they are currently following a complete diet for weight loss (e.g. meal replacement, Slimfast, etc.)
5. currently taking anti-diabetic drugs (e.g. metformin, sulfonylurea, GLP-1 agonist, DPP4-inhibitor, SGLT-2 inhibitor, etc) nor insulin use
6. currently taking medications that interact with Mg supplement
7. currently taking medications that may affect glucose metabolism such as steroids, hormonal therapy (e.g. hormone replacement therapy in postmenopausal), antipsychotics.
8. pregnant and lactating women.
9. have gastrointestinal tract diseases e.g. Inflammatory bowel diseases, irritable bowel syndrome, coeliac disease, including other diseases that involve malabsorption.
10. have kidney disease or impair renal function
11. have auto-immune/connective tissue diseases, malignancy.
12. currently dieting or losing 5% of body weight or more during the last 6 months (or planning to do so in the following year).
13. currently participating in other intervention studies.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04651205
Study Brief:
Protocol Section:
NCT04651205