Effects of Three-Month Coffee Consumption on Metabolic Biomarkers in Adults With Prediabetes and Obesity: a Randomized, Double-blind, Placebo-controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Continuous glucose monitoring parameters
研究概览
简要总结
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.
详细描述
Participants with both prediabetes and obesity who undergo physical examinations at the Health Management Center of Nanjing First Hospital will be recruited for this study. The details of this study design are as follows:
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Inclusion and exclusion criteria for participants. Inclusion criteria are as follows: 1) Age between 18 and 59 years old; 2) Body mass index (BMI) ≥ 28 kg/m2; 3) No consumption of coffee in the past month; 4) Provide written informed consent; 5) Abnormal glucose tolerance, as per the 1999 WHO diagnostic criteria for prediabetes, includes impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or a combination of both, with blood glucose fluctuations within an abnormal range (fasting blood glucose ≥6.1 mmol/L but <7.0 mmol/L, and/or 2-hour glucose tolerance blood glucose ≥7.8 mmol/L but <11.1 mmol/L). The exclusion criteria for participants include individuals who 1) have been diagnosed with diabetes or are taking anti-diabetic drugs; 2) have a history of diseases such as cancer, liver and kidney dysfunction, existing cardiovascular and cerebrovascular diseases, and other diseases that may affect glucose and lipid metabolism; 3) self-report gastrointestinal reaction or intolerance to coffee and reject coffee consumption; 4) are pregnant or planning to become pregnant in the near future; 5) are deemed unsuitable to participate in this study by researcher believes that they are not to participate in this study.
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Sample size calculation: Based on the estimation of research purpose, research design, expected effect size, and statistical analysis method, the sample size is determined to be 100 cases, including fifty cases in the intervention group and fifty cases in the control group.
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Definition of the intervention group and placebo group: the intervention group serves as the coffee capsule group, and will receive 3.6 g of coffee capsules per day (0.3 g/capsule, 6 capsules/time, 2 times/day, once in the morning and once in the middle of the day). The placebo group (control group) is required to consume 3.6 g of cornstarch capsules per day (0.3 g/capsule, 6 capsules/time, 2 times/day, once in the morning and once in the middle of the day).
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Follow-up and data collection: this follow-up period will span three months. Before and after the 3-month intervention the participants will partake in:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 59 years old;
- •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);
- •Body mass index ( BMI ) ≥ 28kg/m2;
- •No coffee intake in the past month;
- •Provide written informed consent and be willing to participate.
排除标准
- •Patients with diagnosis of diabetes, or taking anti-diabetic medication;
- •Patients with cardiovascular or cerebrovascular diseases, cancer, renal disease, liver disease, other chronic diseases affecting glucose and lipid metabolism, etc;
- •Participants with known hypersensitivity or intolerance to coffee, or unwilling to accept coffee;
- •Pregnancy, planned pregnancy, or lactation;
- •Investigators, for any reason, consider the participants inappropriate for the study (e.g., uncontrolled bipolar disease).
研究组 & 干预措施
Coffee capsule
participants in this arm ingest coffee capsules with 1.8g instant black coffee powder twice daily with breakfast and lunch.
干预措施: Coffee capsule (Dietary Supplement)
Placebo
participants in this arm consume cornstarch capsules (without coffee) twice daily with breakfast and lunch.
干预措施: Corn starch capsule (Dietary Supplement)
结局指标
主要结局
Continuous glucose monitoring parameters
时间窗: at baseline, after three-month intervention
14 days blinded intermittent-scanned continuous glucose monitoring (CGM): the FreeStyle Libre Pro system is utilized to record glycemic data, with the readout of the device exclusively performed by researchers. During the day, participants will be blinded to their glucose values.
glucose from a 75 g-oral glucose tolerance test （mmol/L）
时间窗: at baseline, after one-month intervention, after three-month intervention
Blood samples will be drawn at time points 0 min, 30 min, 120 min for glucose measurements during a 75 g-oral glucose tolerance test (75 g-OGTT). Incremental glucose area under the curve (gAUC) will be calculated using the trapezoidal method.
Glycated hemoglobin (HbA1c) ( % )
时间窗: at baseline, after three-month intervention
Reflect the levels of blood sugar in the past two to three months.
insulin from a 75 g-oral glucose tolerance test （pmol/L）
时间窗: at baseline, after one-month intervention, after three-month intervention
Blood samples will be drawn at time points 0 min, 30 min, 120 min for insulin measurements during a 75 g-oral glucose tolerance test (75 g-OGTT). Incremental insulin area under the curve (iAUC) will be calculated using the trapezoidal method.
C-peptide from a 75 g-oral glucose tolerance test (ng/ml)
时间窗: at baseline, after one-month intervention, after three-month intervention
Blood samples will be drawn at time points 0 min, 30 min, 120 min for C-peptide measurements during a 75 g-oral glucose tolerance test (75 g-OGTT).
glucagon from a 75 g-oral glucose tolerance test（pmol/L）
时间窗: at baseline, after one-month intervention, after three-month intervention
Blood samples will be drawn at time points 0 min, 30 min, 120 min for glucagon measurements during a 75 g-oral glucose tolerance test (75 g-OGTT).
Fasting total cholesterol (mmol/L)
时间窗: at baseline, after one-month intervention, after three-month intervention
Serum total cholesterol concentrations under fasting conditions.
Fasting high-density lipoprotein-cholesterol (mmol/L)
时间窗: at baseline, after one-month intervention, after three-month intervention
Serum high-density lipoprotein-cholesterol (HDL-C) concentrations under fasting conditions.
Fasting low-density lipoprotein-cholesterol (mmol/L)
时间窗: at baseline, after one-month intervention, after three-month intervention
Serum low-density lipoprotein-cholesterol ( LDL-C) concentrations under fasting conditions.
Fasting triglycerides (mmol/L)
时间窗: at baseline, after one-month intervention, after three-month intervention
Serum triglycerides concentrations under fasting conditions.
次要结局
- Standard deviation of heart rate variability (SDNN)(at baseline, after one-month intervention, after three-month intervention)
- C-reactive protein(at baseline, after one-month intervention, after three-month intervention)
- Body mass index ( kg/m^2)(at baseline, after one-month intervention, after three-month intervention)
- Interleukin-6(at baseline, after one-month intervention, after three-month intervention)
- Fat mass (FM)(at baseline, after one-month intervention, after three-month intervention)
- body fat percentage (BF)(at baseline, after one-month intervention, after three-month intervention)
- skeletal muscle mass (SMM)(at baseline, after one-month intervention, after three-month intervention)
- Adiponectin(at baseline, after one-month intervention, after three-month intervention)
- Systolic blood pressure（mmHg）(at baseline, after one-month intervention, after three-month intervention)
- Diastolic blood pressure（mmHg）(at baseline, after one-month intervention, after three-month intervention)
- Heart rate （bpm）(at baseline, after one-month intervention, after three-month intervention)
- visceral fat(at baseline, after one-month intervention, after three-month intervention)
- fat-free mass (FFM)(at baseline, after one-month intervention, after three-month intervention)
- Controlled attenuation parameter (CAP)(at baseline, after one-month intervention, after three-month intervention)