An interventional study of Green coffee and Roasted coffee in Overweight and Obesity, sponsored by Instituto de Ciencia y Tecnología de Alimentos y Nutrición. Active, not recruiting at 1 site in Spain. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-11.
Sponsored by Instituto de Ciencia y Tecnología de Alimentos y Nutrición · Not applicable, Interventional, and Basic science
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).
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.
3,771 studies on the registry are indexed under Overweight; 863 are open to participants now.
This study's planned enrollment of 120 is above the median of 73 across 3,263 interventional studies indexed under Overweight.
Browse Overweight studies →Instituto de Ciencia y Tecnología de Alimentos y Nutrición is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Slightly roasted ground Arabica coffee rich in phenolic compounds (hydroxycinnamic acids). Participants will consume 3 cups of freshly brewed coffee daily (breakfast, mid-morning, early afternoon). Black coffee, no milk.
Dietary Supplement: Green coffee
Traditional roasted ground coffee (Arabica). Participants will consume 3 cups of freshly brewed coffee daily (breakfast, mid-morning, early afternoon). Black coffee, no milk.
Dietary Supplement: Roasted coffee
Each cup of coffee provides approximately 400 mg of hydroxycinnamic acids.
Each cup of coffee provides approximately 150 mg of hydroxycinnamic acids.
Body weight
Change in body weight (estimated 2.5 kg) at the end of the intervention
Time frame: 12-week
Body fat percentage
Change in body fat percentage (total and visceral) at the end of the intervention
Time frame: 12 weeks
Blood lipids
Change in serum levels of total cholesterol or LDL-cholesterol, HDL-cholesterol or triglycerides at the end of the intervention
Time frame: 12 weeks
Blood glucose
Change in fasting blood glucose levels at the end of the intervention
Time frame: 12 weeks
Insulin levels
Change in fasting blood insulin levels at the end of the intervention
Time frame: 12 weeks
Insulin resistance
Change in homeostasis model assessment (HOMA) of insulin resistance (HOMA-IR) index at the end of the intervention
Time frame: 12 weeks
Insulin sensitivity
Change in quantitative insulin sensitivity check index (QUICKI) at the end of the intervention.
Time frame: 12 weeks
Glycated hemoglobin
Change in blood levels of glycated hemoglobin (HbA1c) at the end of the intervention
Time frame: 12 weeks
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
Time frame: 12 weeks
Plan to share: Yes — Interested researchers may contact the principal investigator.
Supporting information: Study protocol, Informed consent form, Clinical study report
Time frame: After completion of the study and publication of results
Access criteria: Justified request to the principal investigator
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Instituto de Ciencia y Tecnología de Alimentos y Nutrición