Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06330727
Status:
RECRUITING
Last Update Posted:
2024-03-26
First Post:
2024-03-11
Brief Title:
Effects of Coffee Consumption on Metabolic Markers in Adults With Prediabetes and Obesity
Sponsor:
Nanjing First Hospital Nanjing Medical University
Organization:
Nanjing First Hospital Nanjing Medical University
Study Overview
Official Title:
Effects of Three-Month Coffee Consumption on Metabolic Biomarkers in Adults With Prediabetes and Obesity a Randomized Double-blind Placebo-controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 11 ratio to either the coffee capsule group or the control group The coffee capsule group will be instructed to consume 36 g of coffee capsules per day 03 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 36 g of cornstarch capsules 03 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
Detailed Description:
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
1 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 kgm2 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 61 mmolL but 70 mmolL andor 2-hour glucose tolerance blood glucose 78 mmolL but 111 mmolL 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
2 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
3 Definition of the intervention group and placebo group the intervention group serves as the coffee capsule group and will receive 36 g of coffee capsules per day 03 gcapsule 6 capsulestime 2 timesday once in the morning and once in the middle of the day The placebo group control group is required to consume 36 g of cornstarch capsules per day 03 gcapsule 6 capsulestime 2 timesday once in the morning and once in the middle of the day
4 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
1 regular assessments Demographic characteristics and medical information will be collected including age gender occupation education level income medication history hormones contraceptives etc and family history of chronic diseases Besides using questionnaires we also collect lifestyle information such as smoking drinking diet intake physical activity and sleep of participants Specifically the Simplified Food Frequency Questionnaire FFQ25 and 24-hour Diet Record Questionnaire DR are employed to assess the dietary intake of participants in the past six months and the previous 24 hours one day each in the middle of the week and on the weekend respectively International Physical Activity Questionnaire IPAQ is utilized to assess various aspects of physical activity including time frequency and intensity The sleep information sleep time sleep quality etc is evaluated by Pittsburgh sleep quality index PSQI
2 A 75 g oral glucose tolerance test 75 g-OGTT Blood samples are taken fasting and 30 120 minutes after the glucose load Blood samples are analyzed for glucose insulin C-peptide and glucagon
3 2-week continuous glucose measurement using blinded continuous glucose monitorsensor on upper arm
4 Fasting blood samples glycated hemoglobin HbA1c total cholesterol high-density lipoprotein-cholesterol HDL-C low-density lipoprotein-cholesterol LDL-C triglycerides high sensitivity C-reactive protein CRP interleukin 6 IL-6
5 Furthermore blood pressure transient hepatic elastography for the assessment of fatty liver degree body composition analysis and heart rhythm variation analysis are collected using corresponding instrument and equipment inspection Additionally blood urine and stool samples will be collected for further analysis
1 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 kgm2 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 61 mmolL but 70 mmolL andor 2-hour glucose tolerance blood glucose 78 mmolL but 111 mmolL 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
2 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
3 Definition of the intervention group and placebo group the intervention group serves as the coffee capsule group and will receive 36 g of coffee capsules per day 03 gcapsule 6 capsulestime 2 timesday once in the morning and once in the middle of the day The placebo group control group is required to consume 36 g of cornstarch capsules per day 03 gcapsule 6 capsulestime 2 timesday once in the morning and once in the middle of the day
4 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
1 regular assessments Demographic characteristics and medical information will be collected including age gender occupation education level income medication history hormones contraceptives etc and family history of chronic diseases Besides using questionnaires we also collect lifestyle information such as smoking drinking diet intake physical activity and sleep of participants Specifically the Simplified Food Frequency Questionnaire FFQ25 and 24-hour Diet Record Questionnaire DR are employed to assess the dietary intake of participants in the past six months and the previous 24 hours one day each in the middle of the week and on the weekend respectively International Physical Activity Questionnaire IPAQ is utilized to assess various aspects of physical activity including time frequency and intensity The sleep information sleep time sleep quality etc is evaluated by Pittsburgh sleep quality index PSQI
2 A 75 g oral glucose tolerance test 75 g-OGTT Blood samples are taken fasting and 30 120 minutes after the glucose load Blood samples are analyzed for glucose insulin C-peptide and glucagon
3 2-week continuous glucose measurement using blinded continuous glucose monitorsensor on upper arm
4 Fasting blood samples glycated hemoglobin HbA1c total cholesterol high-density lipoprotein-cholesterol HDL-C low-density lipoprotein-cholesterol LDL-C triglycerides high sensitivity C-reactive protein CRP interleukin 6 IL-6
5 Furthermore blood pressure transient hepatic elastography for the assessment of fatty liver degree body composition analysis and heart rhythm variation analysis are collected using corresponding instrument and equipment inspection Additionally blood urine and stool samples will be collected for further analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None