NCT06204445

Brief 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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 13, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 30, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 12, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

December 11, 2024

Status Verified

December 1, 2024

Enrollment Period

2 years

First QC Date

December 30, 2023

Last Update Submit

December 6, 2024

Conditions

Overweight and Obesity

Keywords

Inter-individual variability(Poly)phenolsGreen coffeeObesityGenotypeMicrobiotaBioavailability and metabolismLifestyleCardiometabolic and inflammatory biomarkers

Outcome Measures

Primary Outcomes (2)

  • Body weight

    Change in body weight (estimated 2.5 kg) at the end of the intervention

    12-week

  • Body fat percentage

    Change in body fat percentage (total and visceral) at the end of the intervention

    12 weeks

Secondary Outcomes (7)

  • Blood lipids

    12 weeks

  • Blood glucose

    12 weeks

  • Insulin levels

    12 weeks

  • Insulin resistance

    12 weeks

  • Insulin sensitivity

    12 weeks

  • +2 more secondary outcomes

Study Arms (2)

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.

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.

Dietary Supplement: Roasted coffee

Interventions

Green coffeeDIETARY_SUPPLEMENT

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

Green (slightly roasted) coffee
Roasted coffeeDIETARY_SUPPLEMENT

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

Roasted coffee

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass index 25-35 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Ciencia y Tecnología de Alimentos y Nutrición

Madrid, Madrid, 28040, Spain

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Laura Bravo, Prof

    Instituto de Ciencia y Tecnología de Alimentos y Nutrición

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2023

First Posted

January 12, 2024

Study Start

December 13, 2022

Primary Completion

December 13, 2024

Study Completion

June 1, 2025

Last Updated

December 11, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

Interested researchers may contact the principal investigator.

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
After completion of the study and publication of results
Access Criteria
Justified request to the principal investigator

Locations

ES(1)