Efficacy and Safety of CKDB-322, a Combination of Lactiplantibacillus plantarum Q180 and Phaeodactylum tricornutum, for Reducing Body Fat and Abdominal Adiposity in Overweight Adults.

CKDB-322 supplementation produced statistically significant reductions in body fat mass and body fat percentage compared to placebo as measured by DEXA.

• Randomized, double-blind, placebo-controlled trial design over 12 weeks
• CKDB-322 group (n = 50) received 1.0 × 10^9 CFU of L. plantarum Q180 and 200 mg of P. tricornutum daily
• Placebo group consisted of n = 50 participants
• Reductions in body fat mass and body fat percentage were statistically significant (p < 0.05)
• Body fat was measured using dual-energy X-ray absorptiometry (DEXA)

CT analyses revealed significant reductions in abdominal fat area in the CKDB-322 group compared to placebo.

• Abdominal fat area was assessed using computed tomography (CT)
• Reductions in abdominal fat area reached statistical significance (p < 0.05)
• Participants were required to have a waist circumference of ≥90 cm for men or ≥85 cm for women at enrollment

Additional improvements in body weight and anthropometric parameters were observed in the CKDB-322 group.

• Participants were aged 19–65 years with a BMI of 25–30 kg/m²
• Body weight and anthropometric measures showed improvements in the CKDB-322 group
• These changes were described as statistically significant improvements in 'multiple adiposity-related outcomes'

Serum triglycerides and leptin levels decreased significantly in the CKDB-322 group compared to placebo.

• Metabolic biomarker analyses included serum triglycerides and leptin
• Both triglycerides and leptin reductions were statistically significant compared to the placebo group
• These findings suggest modulation of metabolic pathways associated with adiposity

Exploratory microbiome analyses indicated an increase in the relative abundance of Lactobacillus in the CKDB-322 group, suggesting potential modulation of the gut-adipose axis.

• Gut microbiome composition was assessed as an exploratory outcome
• Increased relative abundance of Lactobacillus was observed in the CKDB-322 group
• Authors interpreted this finding as suggesting 'potential modulation of the gut-adipose axis'
• These analyses were described as exploratory rather than primary endpoints

CKDB-322 was well tolerated with no clinically significant adverse events or laboratory abnormalities over the 12-week trial.

• Safety was evaluated throughout the 12-week intervention period
• No clinically significant adverse events were reported
• No laboratory abnormalities were identified
• CKDB-322 was described as demonstrating 'a favorable safety profile'