NCT07868302

Brief Summary

This study evaluated thermogenic and physiological responses to 200 mg of caffeine administered following a carbohydrate gel in healthy adults. A total of 36 participants were included and grouped according to body mass index as normal weight, overweight, or obesity. The experimental protocol lasted 120 minutes. Participants received a carbohydrate gel at the beginning of the study, followed by 200 mg of caffeine 45 minutes later. Infrared thermography was used to assess temperature changes in the supraclavicular region, an area associated with brown adipose tissue activity. Core temperature, blood pressure, and heart rate were also measured at several time points. The study aimed to determine whether thermogenic and physiological responses differed according to body mass index and sex. It also evaluated whether absolute temperature values obtained directly from infrared thermography were sufficient on their own to characterize brown adipose tissue-related thermal responses. In addition, the study examined whether other thermal parameters provided complementary information for the interpretation of these responses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 10, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2025

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
Last Updated

October 9, 2026

Status Verified

October 1, 2026

Enrollment Period

5 months

First QC Date

October 3, 2026

Last Update Submit

October 8, 2026

Conditions

Keywords

caffeineInfrared ThermographyBrown Adipose TissueThermogenesisBody Mass IndexSex

Outcome Measures

Primary Outcomes (4)

  • Supraclavicular Temperature (Tscv)

    Right and left supraclavicular regions of interest (ROIs) were manually delineated as triangular areas on infrared thermographic images. For each ROI, the infrared thermography software calculated the mean temperature of the entire delineated area, yielding separate right and left Tscv values. Mean Tscv was then calculated as the arithmetic mean of the right and left Tscv values. Temperature was expressed in degrees Celsius (°C).

    Infrared thermography measurements were repeated every 15 minutes throughout the 120-minute experimental protocol, at baseline (0 min) and at 15, 30, 45, 60, 75, 90, 105, and 120 min.

  • Reference Region Temperature (Tref)

    A circular region of interest (ROI) was manually delineated over the BAT-free sternal region on infrared thermographic images. The infrared thermography software calculated the mean temperature of the entire delineated ROI, yielding the reference region temperature (Tref). Temperature was expressed in degrees Celsius (°C).

    IRT measurements were repeated every 15 minutes throughout the 120-minute experimental protocol, at baseline (0 min) and at 15, 30, 45, 60, 75, 90, 105, and 120 min.

  • Relative Supraclavicular Temperature (Trel)

    Relative supraclavicular temperature (Trel) was calculated as the difference between supraclavicular temperature (Tscv) and reference region temperature (Tref) at each measurement time point (Trel = Tscv - Tref). Right and left Trel values were calculated separately using the corresponding right and left Tscv values and the Tref value. Mean Trel was then calculated as the arithmetic mean of the right and left Trel values. Trel was expressed in degrees Celsius (°C).

    Trel was calculated using the Tscv and Tref values measured by infrared thermography at each time point of the 120-minute experimental protocol: baseline (0 min) and 15, 30, 45, 60, 75, 90, 105, and 120 min.

  • Delta Temperature (ΔT)

    Delta temperature (ΔT) was calculated as the change in supraclavicular temperature from the resting/baseline temperature (Td). The supraclavicular temperature measured at baseline (0 min), before carbohydrate gel administration, was defined as Td. Carbohydrate gel was administered after the baseline measurement, and caffeine was administered at 45 min. Supraclavicular temperatures measured at each subsequent time point (15, 30, 45, 60, 75, 90, 105, and 120 min) were considered stimulated temperatures (Ts), and ΔT was calculated as Ts - Td. Thus, ΔT at each time point represented the change in supraclavicular temperature relative to the baseline value. Right and left ΔT values were calculated separately, and mean ΔT was calculated as the arithmetic mean of the right and left ΔT values. ΔT was expressed in degrees Celsius (°C).

    ΔT was calculated using supraclavicular temperature (Tscv) values measured by infrared thermography (IRT), with the baseline (0 min) Tscv value used as the resting temperature (Td), at 15, 30, 45, 60, 75, 90, 105, and 120 min during the 120-minute experi

Secondary Outcomes (4)

  • Estimated Core Temperature

    Estimated core temperature was measured at baseline (0 min) and at 15, 30, 45, 60, 75, 90, 105, and 120 min during the 120-minute experimental protocol.

  • Systolic Blood Pressure

    Systolic blood pressure was measured at baseline (0 min) and at 15, 30, 45, 60, 75, 90, 105, and 120 min during the 120-minute experimental protocol.

  • Diastolic Blood Pressure

    Diastolic blood pressure was measured at baseline (0 min) and at 15, 30, 45, 60, 75, 90, 105, and 120 min during the 120-minute experimental protocol.

  • Heart Rate

    Heart rate was measured at baseline (0 min) and at 15, 30, 45, 60, 75, 90, 105, and 120 min during the 120-minute experimental protocol.

Study Arms (1)

Carbohydrate Gel Followed by Caffeine

EXPERIMENTAL

All participants received a carbohydrate gel at the beginning of the 120-minute experimental protocol, followed by 200 mg of caffeine at 45 minutes

Dietary Supplement: Carbohydrate GelDietary Supplement: Caffeine

Interventions

Carbohydrate GelDIETARY_SUPPLEMENT

Participants received a carbohydrate gel providing 53 g of carbohydrate (PowerGel Mojito, Ingobio, Türkiye) at the beginning of the 120-minute experimental protocol.

Carbohydrate Gel Followed by Caffeine
CaffeineDIETARY_SUPPLEMENT

Participants received one capsule containing 200 mg of caffeine (Nature's Supreme Caffeine, Türkiye) at 45 minutes during the 120-minute experimental protocol.

Carbohydrate Gel Followed by Caffeine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adults aged 18 years or older.
  • Male or female participants.
  • For female participants, regular menstrual cycles and participation during the follicular phase (days 4-8 of the menstrual cycle).
  • Provision of written informed consent.

You may not qualify if:

  • Diabetes or other metabolic diseases.
  • Use of prescribed medication.
  • Specific treatment for obesity, including bariatric surgery or anti-obesity medication.
  • Caffeine intolerance or caffeine allergy.
  • Regular exercise or physical activity for ≥6 months.
  • Use of supplements that may increase brown adipose tissue activity for ≥3 months (e.g., fish oil, caffeine, or EGCG).
  • Irregular menstrual cycles.
  • Pregnancy or lactation.
  • Habitual alcohol consumption.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Health and Technology University

Istanbul, Istanbul, 34445, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Coitus

Interventions

Caffeine

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Zeynep Ercan Karakaya, PhD

    Istanbul Health and Technology University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: All participants received a carbohydrate gel at the beginning of the protocol, followed by 200 mg of caffeine at 45 minutes during the same 120-minute experimental session.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 3, 2026

First Posted

October 9, 2026

Study Start

December 10, 2024

Primary Completion

May 12, 2025

Study Completion

May 12, 2025

Last Updated

October 9, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because no data-sharing plan was specified in the original study protocol or informed consent documents.

Locations