Investigating how coffee affects metabolic health in adults with prediabetes and obesity
Effects of Three-Month Coffee Consumption on Metabolic Biomarkers in Adults With Prediabetes and Obesity: a Randomized, Double-blind, Placebo-controlled Clinical Trial
This study is testing if drinking coffee can improve metabolic health in adults who have prediabetes and obesity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 59 Years |
| Sex | All |
| Sponsor | Nanjing First Hospital, Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06330727 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to explore the effects of coffee consumption on metabolic markers and inflammation in adults diagnosed with prediabetes and obesity. A total of 100 participants will be recruited and randomly assigned to either a coffee capsule group or a control group receiving corn starch capsules. The coffee group will consume 3.6 grams of coffee capsules daily, while the control group will not receive coffee. The study will assess changes in glucose and lipid metabolism over the trial period, providing insights into the potential benefits of coffee for metabolic health.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 59 with a body mass index of 28 kg/m2 or higher and diagnosed with prediabetes.
Not a fit: Patients who have been diagnosed with diabetes or have other significant health conditions affecting glucose and lipid metabolism may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence that coffee consumption may improve metabolic health and reduce the risk of type 2 diabetes in individuals with prediabetes and obesity.
How similar studies have performed: While epidemiological studies suggest a link between coffee consumption and reduced diabetes risk, randomized controlled trials specifically targeting prediabetes are limited, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age between 18 and 59 years old; 2. Diagnosis of Prediabetes according to the WHO criteria (fasting glucose=6.1-6.9 mmol/L and/or 2-hour post-OGTT glucose=7.8- 11.0 mmol/L); 3. Body mass index ( BMI ) ≥ 28kg/m2; 4. No coffee intake in the past month; 5. Provide written informed consent and be willing to participate. Exclusion Criteria: 1. Patients with diagnosis of diabetes, or taking anti-diabetic medication; 2. Patients with cardiovascular or cerebrovascular diseases, cancer, renal disease, liver disease, other chronic diseases affecting glucose and lipid metabolism, etc; 3. Participants with known hypersensitivity or intolerance to coffee, or unwilling to accept coffee; 4. Pregnancy, planned pregnancy, or lactation; 5. Investigators, for any reason, consider the participants inappropriate for the study (e.g., uncontrolled bipolar disease).
Where this trial is running
Nanjing, Jiangsu
- Nanjing First Hospital — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Jun Wang, M.D.,phD. — Health Management Center of Nanjing First Hospital
- Study coordinator: Jun Wang, M.D.,phD.
- Email: wangjun868@126.com
- Phone: 8613382079966
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.