NCT05156697

Brief Summary

Prior evidence suggests that capsinoids ingestion may increase resting energy expenditure (EE) and fat oxidation (FATox) in humans, although whether they can modulate those parameters during exercise conditions remains poorly understood. Investigators aimed to determine the effects of dihydrocapsiate (DHC) ingestion on EE and FATox during an acute bout of aerobic exercise at FATmax intensity (the intensity that elicits maximal fat oxidation \[MFO\] during exercise) in overweight/obese men. A total of 24 sedentary overweight/obese men participated in this randomized, triple-blinded, placebo-controlled, crossover trial. On the first day, participants underwent a submaximal exercise test in a cycloergometer to determine their MFO and FATmax intensity during exercise. After 72 hours had elapsed, the participants returned in 2 further days (≥ 72 hours apart) and performed a 60 min steady-state test (SST, i.e., cycling at their FATmax, constant intensity) after ingesting either 12 mg of DHC or placebo; these conditions were randomized. Respiratory gas exchange was monitored by indirect calorimetry. Serum markers concentrations (glucose, triglycerides, and non-esterified fatty acids), skin temperature, thermal perception, heart rate and perceived fatigue were assessed as secondary outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 3, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 14, 2021

Completed
Last Updated

December 14, 2021

Status Verified

December 1, 2021

Enrollment Period

9 months

First QC Date

November 12, 2021

Last Update Submit

December 13, 2021

Conditions

Overweight and Obesity

Keywords

capsinoidsdihydrocapsiateFATmaxMFOaerobic exercisenutraceuticalsfood ingredients

Outcome Measures

Primary Outcomes (2)

  • Change in energy expenditure (kcal/day) by indirect calorimetry (CPX Ultima CardioO2 system)

    It will be continuously measured through the 60 minutes-bout of aerobic exercise at FATmax intensity

  • Change in fat oxidation (g/min) by indirect calorimetry (CPX Ultima CardioO2 system)

    It will be continuously measured through the 60 minutes-bout of aerobic exercise at FATmax intensity

Secondary Outcomes (6)

  • Change in serum levels of glucose (mg/dL) by automated analyzer (Beckman Coulter)

    It will be measured at timepoints 0, 15, 30, 45 and 60 minutes, of the 60 minutes-bout of aerobic exercise at FATmax intensity

  • Change in serum levels of triglycerides (mg/dL) by automated analyzer (Beckman Coulter)

    It will be measured at timepoints 0, 15, 30, 45 and 60 minutes, of the 60 minutes-bout of aerobic exercise at FATmax intensity

  • Change in serum levels of non-esterified fatty acids (mmol/L) by automated analyzer (Beckman Coulter)

    It will be measured at timepoints 0, 15, 30, 45 and 60 minutes, of the 60 minutes-bout of aerobic exercise at FATmax intensity

  • Change in skin temperature (ºC) by iButtons wireless thermometers

    It will be continuously measured through the 60 minutes-bout of aerobic exercise at FATmax intensity

  • Change in thermal perception (unitless) by ASHRAE scales

    It will be measured every 15 minutes of the 60 minutes-bout of aerobic exercise at FATmax intensity

  • +1 more secondary outcomes

Study Arms (2)

Placebo + Exercise

PLACEBO COMPARATOR

Placebo pills + 60 min of aerobic exercise

Other: Placebo + Exercise

Dihydrocapsiate + Exercise

EXPERIMENTAL

12 mg of dihydrocapsiate pills + 60 min of aerobic exercise

Dietary Supplement: Capsinoids + Exercise

Interventions

Capsinoids + ExerciseDIETARY_SUPPLEMENT

60 minutes of aerobic exercise (cycle-ergometer) at FATmax intensity + supplementation with 12 mg of dihydrocapsiate (7 min before starting the aerobic exercise)

Dihydrocapsiate + Exercise
Placebo + ExerciseOTHER

60 minutes of aerobic exercise (cycle-ergometer) at FATmax intensity + placebo pills (7 min before starting the aerobic exercise)

Placebo + Exercise

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • to be male
  • to be 18-55 years old
  • to be sedentary (\<20 min moderate-to-vigorous physical activity on \<3 days/week)
  • to be non-smoker
  • not to be under medication
  • to have a stable body weight over the preceding three months (\<3 kg change)

You may not qualify if:

  • having been diagnosed with diabetes, hypertension, or any medical condition(s) that can interfere with or be aggravated by exercise
  • using medication that could affect energy metabolism
  • present a family history of CVD
  • to have an abnormal electrocardiogram, regular and high consumption of spicy foods
  • being frequently exposed to cold temperatures (e.g., indoors/outdoors workspace with low-temperatures, such as cold-storage works, ski/snow monitors, fieldworks during the winter sessions or low-temperatures areas)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Instituto Mixto Universitario Deporte y Salud - iMUDS

Granada, 18007, Spain

Location

Instituto Mixto Universitario Deporte y Salud

Granada, 18007, Spain

Location

Related Publications (1)

  • Osuna-Prieto FJ, Acosta FM, Perez de Arrilucea Le Floc'h UA, Riquelme-Gallego B, Merchan-Ramirez E, Xu H, De La Cruz-Marquez JC, Amaro-Gahete FJ, Llamas-Elvira JA, Trivino-Ibanez EM, Segura-Carretero A, Ruiz JR. Dihydrocapsiate does not increase energy expenditure nor fat oxidation during aerobic exercise in men with overweight/obesity: a randomized, triple-blinded, placebo-controlled, crossover trial. J Int Soc Sports Nutr. 2022 Jul 19;19(1):417-436. doi: 10.1080/15502783.2022.2099757. eCollection 2022.

    PMID: 35875695DERIVED

MeSH Terms

Conditions

OverweightObesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 12, 2021

First Posted

December 14, 2021

Study Start

June 3, 2019

Primary Completion

March 13, 2020

Study Completion

July 1, 2020

Last Updated

December 14, 2021

Record last verified: 2021-12

Locations

ES(2)