Safety and Efficacy of a Novel Green Coffee Bean Extract (GCB‐70) in Overweight Subjects

Abstract

Obesity is now a worldwide epidemic and a novel natural therapeutic intervention is warranted. We have developed a novel, patent‐pending (PCT/IN2015/000236 dated 10th June 2015), water‐soluble green coffee bean extract, GCB‐70) enriched in 70% total chlorogenic acid including 45% caffeoylquinic acid and <1% caffeine in our laboratories. Our earlier studies demonstrated its novel antioxidant efficacy and its potential efficacy in weight management in rodents. This open‐labelled investigation evaluated the efficacy of GCB‐70 in 100 men and women overweight subjects (age: 18–65 years; body weight: 84.04 ± 1.46 kg) and BMI; 31.45 ± 4.49 kg/m2) over a period of 12 weeks. Institutional Review Board (IRB) and other institutional regulatory approvals were obtained for this study. This study was also registered in www.clinicaltrials.gov NCT02703025 Unique Protocol ID: Protocol #CR‐GCB‐ 70/ 07/14). Capsules (500 mg each, b.d.) were administered by the subjects 30–60 min prior to lunch and dinner. This study examined the body weight, BMI, WC and fasting glucose at 0, 4, 8 and 12 weeks of treatment. HbA1c, plasma leptin levels and thyroid stimulating hormone (TSH) were assessed at 0 and 12 weeks of treatment. Furthermore, extensive blood chemistry, adverse events, and physical health of the subjects were extensively evaluated to demonstrate the broad spectrum safety of GCB‐70. Body weight was reduced by 1.9%, 3.9% and 5.9% in male volunteers at 4, 8 and 12 weeks of treatment, respectively, while under these same conditions approximately 2.3%, 3.8% and 6.0% reductions were observed in female volunteers. BMI was reduced by 1.3%, 3.9% and 5.9% in male volunteers at 4, 8 and 12 weeks of treatment, respectively, while under these same conditions approximately 2.3%, 3.9% and 6.1% reductions were observed in female volunteers. Significant reductions in WC and fasting glucose were observed at these same time points in both male and female volunteers. HbA1c and plasma leptin levels were significantly reduced at 90‐days of treatments as compared to the corresponding baseline values, respectively. Blood chemistry data demonstrated the broad spectrum safety of GCB‐70. Overall, the results demonstrate that GCB‐70 is novel, safe and low caffeine antioxidant supplement effective in healthy weight management.Support or Funding InformationThe Study Was Funded by Cepham Inc, Piscataway, NJ