Interindividual Variation in Response to Green Coffee

Overweight and Obesity Clinical Trial

— GREENCOF  

Official title:

Exploratory Study of the Interindividual Variation in Response to Consumption of a Polyphenol-rich Green Coffee and Factor Influencing the Response

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06204445
• Other study ID #: PID2020-114102RB-I00
• Status: Recruiting
• Phase: N/A
• Start date: December 13, 2022
• Est. completion date: June 2025

Study information

• Verified date: January 2024
• Source: Instituto de Ciencia y Tecnología de Alimentos y Nutrición
• Contact: Laura Bravo, Professor
• Phone: +34915492300
• Email: lbravo[@]ictan.csic.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is a multifaceted approach to investigate the effects of regular consumption of green coffee rich in polyphenols (hydroxycinnamic acids) on weight, body composition, cardiometabolic and inflammatory biomarkers in a sample population of overweight and obese people aimed at identifying a population of responders to green coffee experimenting the highest benefit from this product, and to contribute to the understanding of the influence of some of the main factors on the response to green coffee and their association with the differences between individuals (high-responders vs. low-responders).

Description:

A randomized, cross-over, blind clinical trial will be carried out to evaluate the health effects of a polyphenol-rich green (slightly roasted) coffee in comparison with traditional roasted coffee to identify high- and low-responders.

Participants will consume the green and roasted coffee in a randomized order during 12 weeks, separated by a 4-week wash-out (and a previous 2-week run-in). Fasting blood samples will be collected in each of the 6 visits to the research centre. Blood pressure and body composition and anthropometric variables will be measured. In addition, urine and fecal samples will be obtained at the beginning and end of each intervention stage to analyze the bioavailability and metabolism of phenolic compounds, and the intestinal microbiota, respectively. Physical activity and energy expenditure will be measured in each of the interventions.

Besides a thorough cardiometabolic and inflammatory characterization of the volunteers, the frequency of specific genotypes (related with obesity, energy metabolism, inflammation and coffee intake) will be analyzed, as well as lifestyle and dietary habits of the participants, including aspects such as chrono-nutrition, sleep quality and wellbeing perception with the aim to contribute to clarify the determinants of inter-individual variability in the health effects of coffee bioactive phenolic compounds.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Body mass index 25-35 kg/m2

Exclusion Criteria:

• Smoking

• Vegetarian/Vegan

• Pregnant/lactating women

• On prescription drugs other than for thyroid/hypertension/dyslipemia, or changes in dosage in the last 3 months.

• Consumption of vitamins or dietary supplements

• On weight-reduction dietary regime or physical training to reduce body weight

• Having taken antibiotics 3 months before starting the intervention

• Intestinal, hepatic or renal diseases, coffee intolerance

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Dietary Supplement:
• Green coffee
Each cup of coffee provides approximately 400 mg of hydroxycinnamic acids.
• Roasted coffee
Each cup of coffee provides approximately 150 mg of hydroxycinnamic acids.

Locations

Country	Name	City	State
Spain	Instituto de Ciencia y Tecnología de Alimentos y Nutrición	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Instituto de Ciencia y Tecnología de Alimentos y Nutrición	Ministry of Science and Innovation

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight	Change in body weight (estimated 2.5 kg) at the end of the intervention	12-week
Primary	Body fat percentage	Change in body fat percentage (total and visceral) at the end of the intervention	12 weeks
Secondary	Blood lipids	Change in serum levels of total cholesterol or LDL-cholesterol, HDL-cholesterol or triglycerides at the end of the intervention	12 weeks
Secondary	Blood glucose	Change in fasting blood glucose levels at the end of the intervention	12 weeks
Secondary	Insulin levels	Change in fasting blood insulin levels at the end of the intervention	12 weeks
Secondary	Insulin resistance	Change in homeostasis model assessment (HOMA) of insulin resistance (HOMA-IR) index at the end of the intervention	12 weeks
Secondary	Insulin sensitivity	Change in quantitative insulin sensitivity check index (QUICKI) at the end of the intervention.	12 weeks
Secondary	Glycated hemoglobin	Change in blood levels of glycated hemoglobin (HbA1c) at the end of the intervention	12 weeks
Secondary	Inflammatory cytokines	Change in the levels of the pro-inflammatory cytokines tumor necrosis factor-alpha (TNFa), interleukin (IL)-1beta, IL-2, IL-6, or anti-inflammatory IL-10 at the end of the intervention	12 weeks