Overweight and ObesityGREENCOFNCT06204445
Interindividual Variation in Response to Green Coffee
A study testing Green coffee and Roasted coffee in people with Overweight and Obesity, run by Instituto de Ciencia y Tecnología de Alimentos y Nutrición at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Green coffee and Roasted coffee
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 13 Dec 2022to Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index 25-35 kg/m2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Instituto de Ciencia y Tecnología de Alimentos y Nutrición
Madrid, Madrid, 28040
About this study
Official title: Exploratory Study of the Interindividual Variation in Response to Consumption of a Polyphenol-rich Green Coffee and Factor Influencing the Response
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).
Read the detailed 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.
- Conditions
- Overweight and Obesity
- Being tested
- Green coffee, Roasted coffee
- Keywords
- Inter-individual variability, (Poly)phenols, Green coffee, Obesity, Genotype, Microbiota, Bioavailability and metabolism, Lifestyle, Cardiometabolic and inflammatory biomarkers
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green coffeeDietary supplement
Each cup of coffee provides approximately 400 mg of hydroxycinnamic acids.
Roasted coffeeDietary supplement
Each cup of coffee provides approximately 150 mg of hydroxycinnamic acids.
| Study group | Role | What they receive |
|---|---|---|
| Green (slightly roasted) coffee | Experimental | 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. Receives: Dietary Supplement: Green coffee |
| Roasted coffee | Active comparator | Traditional roasted ground coffee (Arabica). Participants will consume 3 cups of freshly brewed coffee daily (breakfast, mid-morning, early afternoon). Black coffee, no milk. Receives: Dietary Supplement: Roasted coffee |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Change in body weight (estimated 2.5 kg) at the end of the intervention
Measured: 12-week
Body fat percentage
Change in body fat percentage (total and visceral) at the end of the intervention
Measured: 12 weeks
Secondary outcomes (7)
Blood lipids
Change in serum levels of total cholesterol or LDL-cholesterol, HDL-cholesterol or triglycerides at the end of the intervention
Measured: 12 weeks
Blood glucose
Change in fasting blood glucose levels at the end of the intervention
Measured: 12 weeks
Insulin levels
Change in fasting blood insulin levels at the end of the intervention
Measured: 12 weeks
Insulin resistance
Change in homeostasis model assessment (HOMA) of insulin resistance (HOMA-IR) index at the end of the intervention
Measured: 12 weeks
Insulin sensitivity
Change in quantitative insulin sensitivity check index (QUICKI) at the end of the intervention.
Measured: 12 weeks
Glycated hemoglobin
Change in blood levels of glycated hemoglobin (HbA1c) at the end of the intervention
Measured: 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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start13 Dec 2022
- Primary completion13 Dec 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Ciencia y Tecnología de Alimentos y Nutrición
- Sponsor type
- Other government
- Collaborators
- Ministry of Science and Innovation, Spain
- Responsible party
- Sponsor
- Investigators
- Laura Bravo, Prof, Principal investigator, Instituto de Ciencia y Tecnología de Alimentos y Nutrición
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204445
- Sponsor's protocol ID
- PID2020-114102RB-I00
- Acronym
- GREENCOF
- Status last verified
- Dec 2024
- First submitted
- 30 Dec 2023
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Interested researchers may contact the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of the Interindividual Variation in Response to Consumption of a Polyphenol-rich Green Coffee and Factor Influencing the Response
- ClinicalTrials.gov ID
- NCT06204445
- Acronym / sponsor ID
- GREENCOF / PID2020-114102RB-I00
- Conditions
- Overweight and Obesity
- Keywords
- Inter-individual variability, (Poly)phenols, Green coffee, Obesity, Genotype, Microbiota, Bioavailability and metabolism, Lifestyle
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Instituto de Ciencia y Tecnología de Alimentos y NutriciónOther government
- Collaborators
- Ministry of Science and Innovation, Spain
- Study start
- 13 Dec 2022 (actual)
- Primary completion
- 13 Dec 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 12 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Green (slightly roasted) coffee | Experimental | Dietary Supplement: Green coffeeSlightly 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. |
| Roasted coffee | Active comparator | Dietary Supplement: Roasted coffeeTraditional roasted ground coffee (Arabica). Participants will consume 3 cups of freshly brewed coffee daily (breakfast, mid-morning, early afternoon). Black coffee, no milk. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Body mass index 25-35 kg/m2
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Green coffeeEach cup of coffee provides approximately 400 mg of hydroxycinnamic acids. | Dietary supplement | Green (slightly roasted) coffee |
| Roasted coffeeEach cup of coffee provides approximately 150 mg of hydroxycinnamic acids. | Dietary supplement | Roasted coffee |
Primary outcome
Body weight
Time frame: 12-week
Change in body weight (estimated 2.5 kg) at the end of the intervention
Body fat percentage
Time frame: 12 weeks
Change in body fat percentage (total and visceral) at the end of the intervention
7 secondary outcomes
Blood lipids
Time frame: 12 weeks
Blood glucose
Time frame: 12 weeks
Insulin levels
Time frame: 12 weeks
Insulin resistance
Time frame: 12 weeks
Insulin sensitivity
Time frame: 12 weeks
Glycated hemoglobin
Time frame: 12 weeks
Inflammatory cytokines
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: Yes. Interested researchers may contact the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Bravo, Prof principal investigator
Instituto de Ciencia y Tecnología de Alimentos y Nutrición
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Green coffee and Roasted coffee in people with Overweight and Obesity, run by Instituto de Ciencia y Tecnología de Alimentos y Nutrición at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: 12-week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.