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COMPLETED
NCT07875699
NA

Development of a Coffee Pulp Infusion as a Strategy for Recovery After Moderate Physical Exercise in a Healthy Population.

Sponsor: David Ramiro Cortijo

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if a coffee pulp infusion works to improve muscle recovery after moderate physical exercise in a healthy adult population. It will also learn about its effects on oxidative stress and inflammation caused by exercise according to sex. The main questions it aims to answer are: * Does the coffee pulp infusion reduce the levels of oxidative stress, inflammation, and muscle damage markers after physical activity? * Are there differences between men and women regarding the response to the exercise and the benefits of the infusion? Researchers will compare the coffee pulp infusion to a placebo (a wheat bran infusion equalized in appearance and flavor but with low bioactive potential) to see if the coffee pulp infusion works to improve muscle recovery. Participants will: * Take the coffee pulp infusion or the placebo twice every day for 45 consecutive days. * Complete a total of 6 clinic and sports center appointments for physical tests, anthropometric records, and hemodynamic monitoring. * Perform a leg extension exercise protocol specifically calibrated to induce muscle stress and fatigue. * Provide capillary blood and morning urine samples at specific time points to measure biomarkers and metabolomic responses. * Complete several questionnaires regarding their sociodemographics, physical activity, dietary index, and perceived muscle soreness or effort.

Official title: Desarrollo de Una infusión de Pulpa de café Como Estrategia Para la recuperación Tras el Ejercicio físico Moderado en Una población Sana.

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

138

Start Date

2024-04-15

Completion Date

2025-12-30

Last Updated

2026-10-15

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

Two 250 mL infusions per day (one in the morning and one at night) for 45 consecutive days.

Randomized, double-blind intervention comparing an optimized functional coffee pulp (CP) infusion to a sensory-matched placebo. The experimental beverage is prepared from dried coffee cherry pulp (Coffea arabica/canephora), optimized via response surface methodology to yield a standardized profile of 120-160 mg GAE/100 mL of total phenolics (chlorogenic, protocatechuic, gallic acids) and caffeine. The control is a placebo prepared from wheat bran extracts with negligible bioactive potential (6 mg GAE/100 mL). To ensure blinding, the placebo is structurally equalized in appearance, color, and flavor using food-grade additives, validated by a trained panel. Both infusions are packed in identical coded bags. Participants in both arms follow the same protocol: consuming two 250 mL infusions daily (morning/night) for 45 consecutive days, utilizing a standardized kit with a 250 mL marked mug and sand color clock to eliminate home-brewing preparation variability.

Locations (1)

Faculty of Medicine, UAM

Madrid, Spain