Changes in Metabolic Rate and Perceptual Indicators After Acute Ingestion of Paraxanthine

NCT05811923 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-04-13

No results posted yet for this study

Summary

The purpose of this study is to evaluate the acute impact of ingesting individual and combined dosages of caffeine and paraxanthine in comparison to placebo on changes in resting metabolic rate, perceived levels of affect, and markers of lipolysis.

Conditions

  • Metabolic Syndrome
  • Caffeine

Interventions

OTHER

Venous Blood Collection

Within each supplementation condition, study participants will have their venous blood collected on six different occasions: 0, 30, 60, 90, 120, and 180 minutes after ingestion of their assigned study agent. Blood will be collected via a forearm vein using standard phlebotomy techniques using either an indwelling catheter or single venipunctures. All blood samples will be collected into ethylenediaminetetraacetic acid EDTA-coated Vacutainer™ tubes and gently inverted ten times before being centrifuged at 3000 revolutions per minute (rpm) (MegaFuge XFR, Thermo Fisher Scientific, Waltham, MA, USA) at 4oC for 20 minutes. After centrifugation, 400 μl aliquots of plasma will be removed and frozen at -80oC within four hours of collection.

OTHER

Resting Metabolic Rate Determination

During all study visits and on six occasions during each of the seven experimental conditions (0, 30, 60, 90, 120, and 180 minutes after supplement ingestion), resting metabolic rates will be determined in a thermoneutral laboratory environment.

OTHER

Mood State

Participants will complete electronic versions of the Profile of Mood States (POMS) questionnaire to evaluate perceptual responses. The Profile of Mood States (POMS) is a 65-item validated scale that uses a 5-point Likert scale with each individual area being scored and summed into profiles for tension, anger, vigor, fatigue, depression, and confusion. Finally, a total mood disturbance score will be calculated by summing all categories and subtracting the vigor score.

OTHER

Visual Analog Scales

Participants will complete electronic versions of the visual analog (VAS) scale to evaluate perceptual responses. Each VAS scale will be completed using a 100-mm line anchored by "Lowest Possible" and "Highest Possible" to assess subjective ratings of focus, anxiety, concentration, energy, restfulness, wakefulness, swagger, confidence, hunger, and appetite. The validity and reliability of VAS to assess fatigue and energy have been previously established (Lee, Hicks, et al. 1991) and our methods have been published elsewhere (Ziegenfuss, Habowski, et al. 2017, Ziegenfuss, Lopez, et al. 2017, Ziegenfuss, Kedia, et al. 2018, Zabriskie, Blumkaitis, et al. 2020).

Sponsors & Collaborators

  • Lindenwood University

    lead OTHER

Principal Investigators

  • Chad M Kerksick, PhD · Lindenwood University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-12
Primary Completion
2022-10-12
Completion
2022-10-12

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05811923 on ClinicalTrials.gov