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:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT04617951
Eligibility Criteria:
Inclusion Criteria:
* \<110% of the standard lean body mass as measured using the body composition analyzer
* Body mass index (BMI) ranging from 18.5 to 30.0 kg/m2
* Those who have an average protein intake of 60 g or more/day.
Exclusion Criteria:
* Abnormal liver or renal function (more than twice the normal upper limit of the research institute)
* Uncontrolled diabetes mellitus (\>160 mg/dL of fasting blood sugar)
* History of fracture during the previous year
* Uncontrolled hypertension (\>160/100 mmHg)
* Uncontrolled thyroid diseases.
* History of serious cerebro-cardiovascular diseases or cancer such as angina or myocardial infarction within 6 months
* History of any central bone fracture within 1 year
* History of medication for psychiatric diseases such as severe depression, schizophrenia, drug intoxication.
* Alcohol abuser
* Allergic reaction to Ishige Okamurae
* Those who participated in other drug clinical trials within 1 month from the screening date.
* Severe gastrointestinal symptoms such as heartburn and indigestion
* Those who are pregnant, lactating, or plan to become pregnant during the clinical trial
* Those who are judged to be unsuitable by the PI for other reasons
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
85 Years
Study:
NCT04617951
Study Brief:
Protocol Section:
NCT04617951