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Interindividual Variation in Response to Green Coffee

NCT ID: NCT06204445

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-13

Study Completion Date

2025-06-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Overweight and Obesity

Keywords

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Inter-individual variability (Poly)phenols Green coffee Obesity Genotype Microbiota Bioavailability and metabolism Lifestyle Cardiometabolic and inflammatory biomarkers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

After a run-in period, participants are randomly allocated to one of each arm. Each intervention last 12 weeks, separated by a 4-week wash-out.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Coffee is provided as ground coffee in unmarked 1 kg packets labeled A or B for blinding, with instructions on how to prepare the coffee brew. The polyphenol-rich coffee is slightly roasted to emulate flavor, color and aroma for blinding.

Assessor will only be presented results marked as intervention A and B. Only the PIs will know the order in which both coffees were consumed by volunteers

Study Groups

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Green (slightly roasted) coffee

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.

Group Type EXPERIMENTAL

Green coffee

Intervention Type DIETARY_SUPPLEMENT

Each cup of coffee provides approximately 400 mg of hydroxycinnamic acids.

Roasted 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.

Group Type ACTIVE_COMPARATOR

Roasted coffee

Intervention Type DIETARY_SUPPLEMENT

Each cup of coffee provides approximately 150 mg of hydroxycinnamic acids.

Interventions

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Green coffee

Each cup of coffee provides approximately 400 mg of hydroxycinnamic acids.

Intervention Type DIETARY_SUPPLEMENT

Roasted coffee

Each cup of coffee provides approximately 150 mg of hydroxycinnamic acids.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ministry of Science and Innovation, Spain

OTHER_GOV

Sponsor Role collaborator

Instituto de Ciencia y Tecnología de Alimentos y Nutrición

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura Bravo, Prof

Role: PRINCIPAL_INVESTIGATOR

Instituto de Ciencia y Tecnología de Alimentos y Nutrición

Locations

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Instituto de Ciencia y Tecnología de Alimentos y Nutrición

Madrid, Madrid, Spain

Site Status

Countries

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Spain

Other Identifiers

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PID2020-114102RB-I00

Identifier Type: -

Identifier Source: org_study_id