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The Effects of Coffee Consumption on Immune Function, Metabolic Function, and Gut Microbiota in the General Population: A Randomized Controlled Clinical Trial

The Effects of Coffee Consumption on Immune Function, Metabolic Function, and Gut Microbiota in the General Population: A Randomized Controlled Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114556
Enrollment
Unknown
Registered
2025-12-15
Start date
2025-12-25
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None

Interventions

Experimental Group 1:Commercial sugar-free coffee products, prepared with plain boiled water
Control group:The daily beverage is plain boiled water
Experimental Group 2:Commercial low-caffeine coffee products, prepared with plain boiled water

Sponsors

The Seventh Affiliated Hospital Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18–65 years, regardless of sex; 2.No severe chronic diseases and a stable health condition in the recent period (within the past 3 months); 3.Has good compliance, is willing to cooperate with the study procedures, and has signed the informed consent form; 4.Able to comply with all examinations and follow-up arrangements during the study;

Exclusion criteria

Exclusion criteria: 1.Previous diagnoses include diabetes, coronary heart disease, cerebrovascular disease, severe hepatic and renal dysfunction, and digestive system diseases (such as peptic ulcers, etc.); 2.Pregnant and breastfeeding women; 3.Use of, or currently taking, medications that affect the gut microbiota or metabolic function within the past month, such as antibiotics, probiotics, prebiotics, hormonal drugs, or immunosuppressants; 4.Those with a history of caffeine allergy or who experience severe adverse reactions to caffeine; 5.Currently participating in, or planning to participate in, other clinical trials during the study period; 6.History of mental illness or poor mental status, unable to cooperate with the study; 7.Individuals with an extreme dietary pattern or extreme exercise habits (such as strict vegetarians, athletes, etc.); 8.Patients with autoimmune diseases; 9.Any other situations that the investigators consider unsuitable for participation in this trial;

Design outcomes

Primary

MeasureTime frame
Changes in the body’s immune status;

Secondary

MeasureTime frame
Changes in the gut microbiota;Fasting blood glucose;Complete blood count;Four blood lipid indices;Insulin;Changes in body metabolism;

Countries

China

Contacts

Public ContactBin Xia

The Seventh Affiliated Hospital Sun Yat-sen University

xiabin2011@126.com+86 755 81206380

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026