PrediabetesNCT06330727
Effects of Coffee Consumption on Metabolic Markers in Adults With Prediabetes and Obesity
A study testing Coffee capsule and Corn starch capsule in people with Prediabetes, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Prediabetes
- What is being tested?
- Coffee capsule and Corn starch capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 5 Feb 2024to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing First Hospital
Nanjing, Jiangsu, 210006
Jun Wang, M.D., PhD., 8613382079966, wangjun868@163.com
Lin Li, PhD., 8615380998768, guobaolimu@126.com
About this study
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
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.
Read the 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:
- 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.
- 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.
- 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).
- 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:
- 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).
- 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.
- 2-week continuous glucose measurement using blinded continuous glucose monitor/sensor on upper arm.
- 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).
- 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.
- Conditions
- Prediabetes
- Being tested
- Coffee capsule, Corn starch capsule
- Keywords
- Prediabetes, Obesity, Coffee, Glucose metabolism, Lipid metabolism, Inflammation
- Medical subject headings
- Prediabetic State, Obesity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coffee capsuleDietary supplement
Also called 0 sugar 0 fat black coffee, instant black coffee. Product standard code: Q/QC 0001S. Food production license number: SC10644190004159.
Take 12 coffee capsules containing 3.6 g instant black coffee powder per day (take 6 coffee capsules twice daily with breakfast and lunch).
Corn starch capsuleDietary supplement
Also called Edible corn starch. Product standard code: GB 31637. Food production license number: SC10313102300041.
Take 12 placebo capsules containing 3.6 g corn starch per day (take 6 placebo capsules twice daily with breakfast and lunch).
| Study group | Role | What they receive |
|---|---|---|
| Coffee capsule | Active comparator | participants in this arm ingest coffee capsules with 1.8g instant black coffee powder twice daily with breakfast and lunch. Receives: Dietary Supplement: Coffee capsule |
| Placebo | Placebo comparator | participants in this arm consume cornstarch capsules (without coffee) twice daily with breakfast and lunch. Receives: Dietary Supplement: Corn starch capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous glucose monitoring parameters
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.
Measured: at baseline, after three-month intervention
glucose from a 75 g-oral glucose tolerance test （mmol/L）
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.
Measured: at baseline, after one-month intervention, after three-month intervention
insulin from a 75 g-oral glucose tolerance test （pmol/L）
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.
Measured: at baseline, after one-month intervention, after three-month intervention
C-peptide from a 75 g-oral glucose tolerance test (ng/ml)
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).
Measured: at baseline, after one-month intervention, after three-month intervention
glucagon from a 75 g-oral glucose tolerance test（pmol/L）
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).
Measured: at baseline, after one-month intervention, after three-month intervention
Glycated hemoglobin (HbA1c) ( % )
Reflect the levels of blood sugar in the past two to three months.
Measured: at baseline, after three-month intervention
Fasting total cholesterol (mmol/L)
Serum total cholesterol concentrations under fasting conditions.
Measured: at baseline, after one-month intervention, after three-month intervention
Fasting high-density lipoprotein-cholesterol (mmol/L)
Serum high-density lipoprotein-cholesterol (HDL-C) concentrations under fasting conditions.
Measured: at baseline, after one-month intervention, after three-month intervention
Fasting low-density lipoprotein-cholesterol (mmol/L)
Serum low-density lipoprotein-cholesterol ( LDL-C) concentrations under fasting conditions.
Measured: at baseline, after one-month intervention, after three-month intervention
Fasting triglycerides (mmol/L)
Serum triglycerides concentrations under fasting conditions.
Measured: at baseline, after one-month intervention, after three-month intervention
Secondary outcomes (14)
C-reactive protein
Serum levels of inflammatory factors: high-sensitivity C-reactive protein (CRP).
Measured: at baseline, after one-month intervention, after three-month intervention
Interleukin-6
Serum levels of inflammatory factors: interleukin-6 (IL-6).
Measured: at baseline, after one-month intervention, after three-month intervention
Body mass index ( kg/m^2)
Calculation of body mass index (BMI) using body weight and height.
Measured: at baseline, after one-month intervention, after three-month intervention
Fat mass (FM)
Assessed using an InBody bioelectrical impedance analyzer.
Measured: at baseline, after one-month intervention, after three-month intervention
body fat percentage (BF)
Assessed using an InBody bioelectrical impedance analyzer.
Measured: at baseline, after one-month intervention, after three-month intervention
visceral fat
Assessed using an InBody bioelectrical impedance analyzer.
Measured: at baseline, after one-month intervention, after three-month intervention
skeletal muscle mass (SMM)
Assessed using an InBody bioelectrical impedance analyzer.
Measured: at baseline, after one-month intervention, after three-month intervention
fat-free mass (FFM)
Assessed using an InBody bioelectrical impedance analyzer.
Measured: at baseline, after one-month intervention, after three-month intervention
Adiponectin
high-molecular-weight adiponectin
Measured: at baseline, after one-month intervention, after three-month intervention
Systolic blood pressure（mmHg）
After 20 min of rest, blood pressure will be measured between 8:00 and 9:00 in the morning by an experienced nurse and the average of three consecutive measurements will be recorded.
Measured: at baseline, after one-month intervention, after three-month intervention
Diastolic blood pressure（mmHg）
After 20 min of rest, blood pressure will be measured between 8:00 and 9:00 in the morning by an experienced nurse and the average of three consecutive measurements will be recorded.
Measured: at baseline, after one-month intervention, after three-month intervention
Heart rate （bpm）
After 20 min of rest, heart rate will be measured between 8:00 and 9:00 in the morning by an experienced nurse and the average of three consecutive measurements will be recorded.
Measured: at baseline, after one-month intervention, after three-month intervention
Controlled attenuation parameter (CAP)
Controlled attenuation parameter (CAP) by transient hepatic elastography (THE) assesses the degree of hepatic steatosis.
Measured: at baseline, after one-month intervention, after three-month intervention
Standard deviation of heart rate variability (SDNN)
Heart Rhythm Variation Analysis.
Measured: at baseline, after one-month intervention, after three-month intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start5 Feb 2024
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Wang, M.D.,phD., Principal investigator, Health Management Center of Nanjing First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330727
- Sponsor's protocol ID
- KY20231109-09
- Status last verified
- Mar 2024
- First submitted
- 11 Mar 2024
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ding M, Bhupathiraju SN, Chen M, van Dam RM, Hu FB. Caffeinated and decaffeinated coffee consumption and risk of type 2 diabetes: a systematic review and a dose-response meta-analysis. Diabetes Care. 2014 Feb;37(2):569-86. doi: 10.2337/dc13-1203.
PubMed 24459154Scheen AJ, Letiexhe MR, Ernest P. [Prevention of type 2 diabetes: lifestyle changes or pharmacological interventions?]. Rev Med Liege. 2003 Apr;58(4):206-10. French.
PubMed 12868322Schulze MB, Hu FB. Primary prevention of diabetes: what can be done and how much can be prevented? Annu Rev Public Health. 2005;26:445-67. doi: 10.1146/annurev.publhealth.26.021304.144532.
PubMed 15760297Magis D, Geronooz I, Scheen AJ. [Smoking, insulin resistance and type 2 diabetes]. Rev Med Liege. 2002 Sep;57(9):575-81. French.
PubMed 12440345Higdon JV, Frei B. Coffee and health: a review of recent human research. Crit Rev Food Sci Nutr. 2006;46(2):101-23. doi: 10.1080/10408390500400009.
PubMed 16507475van Dam RM. Coffee and type 2 diabetes: from beans to beta-cells. Nutr Metab Cardiovasc Dis. 2006 Jan;16(1):69-77. doi: 10.1016/j.numecd.2005.10.003. Epub 2005 Dec 13.
PubMed 16399494Bellou V, Belbasis L, Tzoulaki I, Evangelou E. Risk factors for type 2 diabetes mellitus: An exposure-wide umbrella review of meta-analyses. PLoS One. 2018 Mar 20;13(3):e0194127. doi: 10.1371/journal.pone.0194127. eCollection 2018.
PubMed 29558518Kondo Y, Goto A, Noma H, Iso H, Hayashi K, Noda M. Effects of Coffee and Tea Consumption on Glucose Metabolism: A Systematic Review and Network Meta-Analysis. Nutrients. 2018 Dec 27;11(1):48. doi: 10.3390/nu11010048.
PubMed 30591664Bae JM. Coffee consumption and risk of type 2 diabetes mellitus in Asians: A meta-epidemiological study of population-based cohort studies. World J Diabetes. 2021 Jun 15;12(6):908-915. doi: 10.4239/wjd.v12.i6.908.
PubMed 34168737Di Maso M, Boffetta P, Negri E, La Vecchia C, Bravi F. Caffeinated Coffee Consumption and Health Outcomes in the US Population: A Dose-Response Meta-Analysis and Estimation of Disease Cases and Deaths Avoided. Adv Nutr. 2021 Jul 30;12(4):1160-1176. doi: 10.1093/advances/nmaa177.
PubMed 33570108Osama H, Abdelrahman MA, Madney YM, Harb HS, Saeed H, Abdelrahim MEA. Coffee and type 2 diabetes risk: Is the association mediated by adiponectin, leptin, c-reactive protein or Interleukin-6? A systematic review and meta-analysis. Int J Clin Pract. 2021 Jun;75(6):e13983. doi: 10.1111/ijcp.13983. Epub 2021 Jan 21.
PubMed 33400346Shahinfar H, Jayedi A, Khan TA, Shab-Bidar S. Coffee consumption and cardiovascular diseases and mortality in patients with type 2 diabetes: A systematic review and dose-response meta-analysis of cohort studies. Nutr Metab Cardiovasc Dis. 2021 Aug 26;31(9):2526-2538. doi: 10.1016/j.numecd.2021.05.014. Epub 2021 May 24.
PubMed 34112583Carlstrom M, Larsson SC. Coffee consumption and reduced risk of developing type 2 diabetes: a systematic review with meta-analysis. Nutr Rev. 2018 Jun 1;76(6):395-417. doi: 10.1093/nutrit/nuy014.
PubMed 29590460Bhupathiraju SN, Pan A, Manson JE, Willett WC, van Dam RM, Hu FB. Changes in coffee intake and subsequent risk of type 2 diabetes: three large cohorts of US men and women. Diabetologia. 2014 Jul;57(7):1346-54. doi: 10.1007/s00125-014-3235-7. Epub 2014 Apr 26.
PubMed 24771089van Dam RM, Feskens EJ. Coffee consumption and risk of type 2 diabetes mellitus. Lancet. 2002 Nov 9;360(9344):1477-8. doi: 10.1016/S0140-6736(02)11436-X.
PubMed 12433517
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06330727
- Acronym / sponsor ID
- KY20231109-09
- Conditions
- Prediabetes
- Keywords
- Prediabetes, Obesity, Coffee, Glucose metabolism, Lipid metabolism, Inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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.
- 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).
- 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:
- 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).
- 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.
- 2-week continuous glucose measurement using blinded continuous glucose monitor/sensor on upper arm.
- 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).
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coffee capsule | Active comparator | Dietary Supplement: Coffee capsuleparticipants in this arm ingest coffee capsules with 1.8g instant black coffee powder twice daily with breakfast and lunch. |
| Placebo | Placebo comparator | Dietary Supplement: Corn starch capsuleparticipants in this arm consume cornstarch capsules (without coffee) twice daily with breakfast and lunch. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coffee capsuleAlso: 0 sugar 0 fat black coffee, instant black coffee. Product standard code: Q/QC 0001S. Food production license number: SC10644190004159.Take 12 coffee capsules containing 3.6 g instant black coffee powder per day (take 6 coffee capsules twice daily with breakfast and lunch). | Dietary supplement | Coffee capsule |
| Corn starch capsuleAlso: Edible corn starch. Product standard code: GB 31637. Food production license number: SC10313102300041.Take 12 placebo capsules containing 3.6 g corn starch per day (take 6 placebo capsules twice daily with breakfast and lunch). | Dietary supplement | Placebo |
Primary outcome
Continuous glucose monitoring parameters
Time frame: 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）
Time frame: 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.
insulin from a 75 g-oral glucose tolerance test （pmol/L）
Time frame: 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)
Time frame: 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）
Time frame: 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).
Glycated hemoglobin (HbA1c) ( % )
Time frame: at baseline, after three-month intervention
Reflect the levels of blood sugar in the past two to three months.
Fasting total cholesterol (mmol/L)
Time frame: at baseline, after one-month intervention, after three-month intervention
Serum total cholesterol concentrations under fasting conditions.
Fasting high-density lipoprotein-cholesterol (mmol/L)
Time frame: 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)
Time frame: 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)
Time frame: at baseline, after one-month intervention, after three-month intervention
Serum triglycerides concentrations under fasting conditions.
14 secondary outcomes
C-reactive protein
Time frame: at baseline, after one-month intervention, after three-month intervention
Interleukin-6
Time frame: at baseline, after one-month intervention, after three-month intervention
Body mass index ( kg/m^2)
Time frame: at baseline, after one-month intervention, after three-month intervention
Fat mass (FM)
Time frame: at baseline, after one-month intervention, after three-month intervention
body fat percentage (BF)
Time frame: at baseline, after one-month intervention, after three-month intervention
visceral fat
Time frame: at baseline, after one-month intervention, after three-month intervention
skeletal muscle mass (SMM)
Time frame: at baseline, after one-month intervention, after three-month intervention
fat-free mass (FFM)
Time frame: at baseline, after one-month intervention, after three-month intervention
Adiponectin
Time frame: at baseline, after one-month intervention, after three-month intervention
Systolic blood pressure（mmHg）
Time frame: at baseline, after one-month intervention, after three-month intervention
Diastolic blood pressure（mmHg）
Time frame: at baseline, after one-month intervention, after three-month intervention
Heart rate （bpm）
Time frame: at baseline, after one-month intervention, after three-month intervention
Controlled attenuation parameter (CAP)
Time frame: at baseline, after one-month intervention, after three-month intervention
Standard deviation of heart rate variability (SDNN)
Time frame: at baseline, after one-month intervention, after three-month intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Background: PubMed 24459154Ding M, Bhupathiraju SN, Chen M, van Dam RM, Hu FB. Caffeinated and decaffeinated coffee consumption and risk of type 2 diabetes: a systematic review and a dose-response meta-analysis. Diabetes Care. 2014 Feb;37(2):569-86. doi: 10.2337/dc13-1203.
- Background: PubMed 12868322Scheen AJ, Letiexhe MR, Ernest P. [Prevention of type 2 diabetes: lifestyle changes or pharmacological interventions?]. Rev Med Liege. 2003 Apr;58(4):206-10. French.
- Background: PubMed 15760297Schulze MB, Hu FB. Primary prevention of diabetes: what can be done and how much can be prevented? Annu Rev Public Health. 2005;26:445-67. doi: 10.1146/annurev.publhealth.26.021304.144532.
- Background: PubMed 12440345Magis D, Geronooz I, Scheen AJ. [Smoking, insulin resistance and type 2 diabetes]. Rev Med Liege. 2002 Sep;57(9):575-81. French.
- Background: PubMed 16507475Higdon JV, Frei B. Coffee and health: a review of recent human research. Crit Rev Food Sci Nutr. 2006;46(2):101-23. doi: 10.1080/10408390500400009.
- Background: PubMed 16399494van Dam RM. Coffee and type 2 diabetes: from beans to beta-cells. Nutr Metab Cardiovasc Dis. 2006 Jan;16(1):69-77. doi: 10.1016/j.numecd.2005.10.003. Epub 2005 Dec 13.
- Background: PubMed 29558518Bellou V, Belbasis L, Tzoulaki I, Evangelou E. Risk factors for type 2 diabetes mellitus: An exposure-wide umbrella review of meta-analyses. PLoS One. 2018 Mar 20;13(3):e0194127. doi: 10.1371/journal.pone.0194127. eCollection 2018.
- Background: PubMed 30591664Kondo Y, Goto A, Noma H, Iso H, Hayashi K, Noda M. Effects of Coffee and Tea Consumption on Glucose Metabolism: A Systematic Review and Network Meta-Analysis. Nutrients. 2018 Dec 27;11(1):48. doi: 10.3390/nu11010048.
- Background: PubMed 34168737Bae JM. Coffee consumption and risk of type 2 diabetes mellitus in Asians: A meta-epidemiological study of population-based cohort studies. World J Diabetes. 2021 Jun 15;12(6):908-915. doi: 10.4239/wjd.v12.i6.908.
- Background: PubMed 33570108Di Maso M, Boffetta P, Negri E, La Vecchia C, Bravi F. Caffeinated Coffee Consumption and Health Outcomes in the US Population: A Dose-Response Meta-Analysis and Estimation of Disease Cases and Deaths Avoided. Adv Nutr. 2021 Jul 30;12(4):1160-1176. doi: 10.1093/advances/nmaa177.
- Background: PubMed 33400346Osama H, Abdelrahman MA, Madney YM, Harb HS, Saeed H, Abdelrahim MEA. Coffee and type 2 diabetes risk: Is the association mediated by adiponectin, leptin, c-reactive protein or Interleukin-6? A systematic review and meta-analysis. Int J Clin Pract. 2021 Jun;75(6):e13983. doi: 10.1111/ijcp.13983. Epub 2021 Jan 21.
- Background: PubMed 34112583Shahinfar H, Jayedi A, Khan TA, Shab-Bidar S. Coffee consumption and cardiovascular diseases and mortality in patients with type 2 diabetes: A systematic review and dose-response meta-analysis of cohort studies. Nutr Metab Cardiovasc Dis. 2021 Aug 26;31(9):2526-2538. doi: 10.1016/j.numecd.2021.05.014. Epub 2021 May 24.
- Individual participant dataSharing planned: No
Related trials for Prediabetes
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
Recruiting
CGM-Enhanced DPP to Prevent Type 2 Diabetes in Adults With Prediabetes
PreDiabetes
Not yet recruiting
Different Aerobic-to-Resistance Training Ratios in Adults Aged 50 Years and Older With Prediabetes
Prediabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Wang, M.D.,phD. principal investigator
Health Management Center of Nanjing First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coffee capsule and Corn starch capsule in people with Prediabetes, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Wang, M.D.,phD. (8613382079966, wangjun868@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous glucose monitoring parameters (time frame: at baseline, after three-month intervention). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06330727, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024; AzTrials last refreshed its copy on 8 Nov 2026.