Black ginger extract effect on weight, body fat and hunger in overweight adults

INTERVENTION: This is a single‐centre, prospective, randomized, double‐blind, placebo‐controlled, parallel‐group clinical study in overweight adults. Eligible participants are randomized in a 1:1:1 ratio. Block randomisation is used to allocate participants to each group: black ginger extract, ginger powder or placebo for 8 weeks. Participants in the intervention group receive 300 mg of black ginger extract orally once daily for 8 weeks. Participants in the active comparator group receive ginger powder orally once daily for 8 weeks. Participants in the control group receive a matching placebo orally once daily for 8 weeks. The study products and placebo are packaged in identical containers labelled with the trial number to maintain blinding of both participants and investigators. Randomization is performed using a pre‐specified allocation schedule to ensure equal distribution among the three study arms. Anthropometric measurements, including body weight, body mass index, fat mass and lean mass, are assessed at baseline and after 2, 4 and 8 weeks of treatment. Blood samples are collected following an overnight fast at baseline and at week 8 to measure serum adiponectin, leptin and glucagon‐like peptide‐1 concentrations. Safety assessments include physical examinations, laboratory evaluations and monitoring of adverse events throughout the study period. CONDITION: Overweight and obesity‐related metabolic risk in overweight adults. ; Nutritional, Metabolic, Endocrine PRIMARY OUTCOME: Fat mass, lean mass, and BMI measured using bioelectrical impedance analysis at day 0, day 14, day 30 and day 56 Weight measured using a calibrated digital weighing scale at day 0, day 14, day 30 and day 56 SECONDARY OUTCOME: Serum adiponectin measured using enzyme‐linked immunosorbent assay at day 0, day 14, day 30 and day 56 Serum leptin measured using enzyme‐linked immunosorbent assay at day 0, day 14, day 30 and day 56 Serum levels of glucagon‐like peptide‐1 measured using radioimmunoassay at day 0, day 14, day 30 and day 56 INCLUSION CRITERIA: 1. Male or female adults aged 18 years and above 2. Body mass inde Xbetween 25.0 and 29.9 kg/m² (inclusive) 3. Generally healthy with no known chronic systemic illness 4. Able and willing to provide written informed consent 5. Willing to comply with study procedures and attend scheduled visits throughout the study period