nctId: NCT06330727 id: KY20231109-09 briefTitle: Effects of Coffee Consumption on Metabolic Markers in Adults With Prediabetes and Obesity overallStatus: RECRUITING date: 2024-02-05 date: 2024-10 date: 2024-10 date: 2024-03-26 date: 2024-03-26 name: Nanjing First Hospital, Nanjing Medical University class: OTHER briefSummary: Epidemiological studies have shown an inverse association between coffee consumption and risk of type 2 diabetes. However, the randomized controlled trials in prediabetes are limited to evaluate the effects of coffee. The purpose of this study is to investigate the effects of coffee on metabolic factors and inflammation in individuals with prediabetes and obesity. A double-blind, randomized controlled trial is designed to explore the effects of coffee consumption on participants with prediabetes and obesity. A total of 100 eligible participants with prediabetes and obesity will be recruited from the Health Management Center of Nanjing First Hospital. These participants are randomly assigned in a 1:1 ratio to either the coffee capsule group or the control group. The coffee capsule group will be instructed to consume 3.6 g of coffee capsules per day (0.3 g per capsule, 6 capsules per serving, twice a day, once in the morning and once in the middle of the day). The control group will be asked to consume 3.6 g of cornstarch capsules (0.3 g per capsule, 6 capsules per serving, twice a day, once in the morning and once in the middle of the day). 75 g oral glucose tolerance test, 2-week blinded continuous glucose measurement and others will be performed before and after the 3-month intervention. During the three months of intervention, the information on dietary intake, physical activity and sleep of participants will be systematically collected. To comprehensively assess the impact of coffee intake on prediabetes and obesity, we will analyze the effects of coffee capsules on various metabolic and inflammatory markers, including glucose metabolism, lipid profiles, blood pressure, adiponectin, high sensitivity C-reactive protein, interleukin-6, body mass index, body composition, the degree of hepatic steatosis and so on. We will further adjust for potential confounding factors such as lifestyle factors to better understand the underlying biological mechanisms driving this association. conditions: Prediabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 100 type: ESTIMATED name: Coffee capsule name: Corn starch capsule measure: Continuous glucose monitoring parameters measure: glucose from a 75 g-oral glucose tolerance test （mmol/L） measure: insulin from a 75 g-oral glucose tolerance test （pmol/L） measure: C-peptide from a 75 g-oral glucose tolerance test (ng/ml) measure: glucagon from a 75 g-oral glucose tolerance test（pmol/L） measure: Glycated hemoglobin (HbA1c) ( % ) measure: Fasting total cholesterol (mmol/L) measure: Fasting high-density lipoprotein-cholesterol (mmol/L) measure: Fasting low-density lipoprotein-cholesterol (mmol/L) measure: Fasting triglycerides (mmol/L) measure: C-reactive protein measure: Interleukin-6 measure: Body mass index ( kg/m^2) measure: Fat mass (FM) measure: body fat percentage (BF) measure: visceral fat measure: skeletal muscle mass (SMM) measure: fat-free mass (FFM) measure: Adiponectin measure: Systolic blood pressure（mmHg） measure: Diastolic blood pressure（mmHg） measure: Heart rate （bpm） measure: Controlled attenuation parameter (CAP) measure: Standard deviation of heart rate variability (SDNN) sex: ALL minimumAge: 18 Years maximumAge: 59 Years stdAges: ADULT facility: Nanjing First Hospital status: RECRUITING city: Nanjing state: Jiangsu zip: 210006 country: China name: Jun Wang, M.D., PhD. role: CONTACT phone: 8613382079966 email: wangjun868@163.com name: Lin Li, PhD. role: CONTACT phone: 8615380998768 email: guobaolimu@126.com lat: 32.06167 lon: 118.77778 hasResults: False