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
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 59
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
China
Nanjing First Hospital
RECRUITING
Nanjing
Contact Information
Primary
Jun Wang, M.D.,phD.
wangjun868@126.com
8613382079966
Backup
Lin Li, phD.
guobaolimu@126.com
8615380998768
Time Frame
Start Date: 2024-02-05
Estimated Completion Date: 2024-10
Participants
Target number of participants: 100
Treatments
Active_comparator: Coffee capsule
participants in this arm ingest coffee capsules with 1.8g instant black coffee powder twice daily with breakfast and lunch.
Placebo_comparator: Placebo
participants in this arm consume cornstarch capsules (without coffee) twice daily with breakfast and lunch.
Related Therapeutic Areas
Sponsors
Leads: Nanjing First Hospital, Nanjing Medical University

This content was sourced from clinicaltrials.gov