Investigating the utility of prunus mume extract supplementation combined with choline in patients with type 2 diabetes mellitus: a randomized, prospective, two-arm study in primary healthcare.
(NAFLD) in adults, with a focus on metabolic, inflammatory, and hepatic biomarkers.
Prospective participants will be drawn from a pool of adult patients with Diabetes Mellitus Type 2 who are monitored at the Principal Investigator's private practice in the city of Heraklion, Crete, among those who meet the inclusion criteria and do not fall under the exclusion criteria. This is a randomized, prospective, two-arm interventional study. Recruitment will be based on the overview of possible participants’ most recent laboratory tests and medical history. Participants will undergo liver ultrasound screening to detect and quantify fatty infiltration and assess liver fibrosis using ultrasound elastography. Eligible participants will be randomly allocated into the control or the intervention group. Participants in the intervention group receive a dietary supplement containing 150 mg Prunus mume extract combined with 82.5 mg Choline bitartrate, administered orally once daily for a period of three months. Participants in the control group do not receive Prunus mume extract or any placebo and continue with their usual care and habitual lifestyle throughout the study period. Randomisation is performed using a predefined allocation procedure to assign participants to either the intervention or control group. All participants undergo the same assessments, including measurements related to liver function, metabolic status, and inflammatory markers, at baseline and at the end of the intervention period.
1. Adults with a Diagnosis of Diabetes Mellitus Type 2 2. The ability and willingness to provide written informed consent 3. The ability to comply with the study procedures and assessments
1. Evidence of liver disease of other aetiology (e.g. viral hepatitis, autoimmune liver disease, alcoholic liver disease) 2. Known allergies or hypersensitivity to components of the investigational product (Prunus mume extract and Choline) 3. Known severe Renal Disease or Severe Chronic Heart Failure 4. Active neoplasms or a history of cancer other than hepatocellular carcinoma 5. Taking medication that may affect choline metabolism or cause liver damage 6. Pregnancy or breastfeeding, or intention to become pregnant during the study period 7. Participation in another clinical or interventional study within a recent period prior to enrolment