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NCT Number: NCT06204445

Interindividual Variation in Response to Green Coffee

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Overweight and Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto de Ciencia y Tecnología de Alimentos y Nutrición

Madrid, 28040, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Green coffee

Dietary Supplement

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

Roasted coffee

Dietary Supplement

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

Primary outcomes

  1. Body weight

    Time frame: 12-week

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

  2. Body fat percentage

    Time frame: 12 weeks

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

Secondary outcomes

  1. Blood lipids

    Time frame: 12 weeks

    Change in serum levels of total cholesterol or LDL-cholesterol, HDL-cholesterol or triglycerides at the end of the intervention

  2. Blood glucose

    Time frame: 12 weeks

    Change in fasting blood glucose levels at the end of the intervention

  3. Insulin levels

    Time frame: 12 weeks

    Change in fasting blood insulin levels at the end of the intervention

  4. Insulin resistance

    Time frame: 12 weeks

    Change in homeostasis model assessment (HOMA) of insulin resistance (HOMA-IR) index at the end of the intervention

  5. Insulin sensitivity

    Time frame: 12 weeks

    Change in quantitative insulin sensitivity check index (QUICKI) at the end of the intervention.

  6. Glycated hemoglobin

    Time frame: 12 weeks

    Change in blood levels of glycated hemoglobin (HbA1c) at the end of the intervention

  7. Inflammatory cytokines

    Time frame: 12 weeks

    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

Sponsors and collaborators

Lead sponsor

Instituto de Ciencia y Tecnología de Alimentos y Nutrición

Other Gov

Collaborators

  • Ministry of Science and Innovation, Spain

Registry information

Official study title

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

Acronym: GREENCOF

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jan 12, 2024
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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