Effects of Coffee Consumption on Metabolic Markers in Adults With Prediabetes and Obesity

NCT06330727 | Recruiting DMC

• 1 other identifier: KY20231109-09
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 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

Keywords

Prediabetes; Obesity; Coffee; Glucose metabolism; Lipid metabolism; Inflammation

Outcome Measures

Primary Outcomes (10)

• 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.

  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.

  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.

  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).

  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).

  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.

  at baseline, after three-month intervention

• Fasting total cholesterol (mmol/L)

  Serum total cholesterol concentrations under fasting conditions.

  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.

  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.

  at baseline, after one-month intervention, after three-month intervention

• Fasting triglycerides (mmol/L)

  Serum triglycerides concentrations under fasting conditions.

  at baseline, after one-month intervention, after three-month intervention

Secondary Outcomes (14)

• C-reactive protein

  at baseline, after one-month intervention, after three-month intervention

• Interleukin-6

  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

• 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

Study Arms (2)

Coffee capsule

ACTIVE COMPARATOR

participants in this arm ingest coffee capsules with 1.8g instant black coffee powder twice daily with breakfast and lunch.

Dietary Supplement: Coffee capsule

Placebo

PLACEBO COMPARATOR

participants in this arm consume cornstarch capsules (without coffee) twice daily with breakfast and lunch.

Dietary Supplement: Corn starch capsule

Interventions

Coffee capsule DIETARY_SUPPLEMENT

Take 12 coffee capsules containing 3.6 g instant black coffee powder per day (take 6 coffee capsules twice daily with breakfast and lunch).

Also known as: 0 sugar 0 fat black coffee, instant black coffee. Product standard code: Q/QC 0001S. Food production license number: SC10644190004159.

Coffee capsule

Corn starch capsule DIETARY_SUPPLEMENT

Take 12 placebo capsules containing 3.6 g corn starch per day (take 6 placebo capsules twice daily with breakfast and lunch).

Also known as: Edible corn starch. Product standard code: GB 31637. Food production license number: SC10313102300041.

Placebo

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

RECRUITING

Related Publications (29)

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MeSH Terms

Conditions

Prediabetic State; Obesity; Inflammation

Interventions

Coffee; Starch

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Officials

• Jun Wang, M.D.,phD.

  Health Management Center of Nanjing First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Wang, M.D.,phD.

CONTACT

8613382079966; wangjun868@126.com

Lin Li, phD.

CONTACT

8615380998768; guobaolimu@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 26, 2024
• Study Start: February 5, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)