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Not Yet Recruiting NCT05619809

Chronic Thermogenic Dietary Supplement Consumption

Conditions: Body Composition Changes, Body Weight Changes, Anthropometric Changes, Metabolism Changes, Hemodynamic Changes

Sex: All
Ages: 18 Years – 40 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 50
Sponsor: Texas Tech University

Location: United States

Summary

This study is a randomized, double-blind, placebo-controlled trial. Healthy, exercising adult males and females will be recruited for participation. After providing informed consent, each participant will be randomized to one of three groups: 1) OxyShred thermogenic fat burner; 2) Placebo (PL); and 3) Control. All participants will complete a baseline laboratory visit consisting of assessments of body composition, anthropometry, metabolism, hemodynamics, dietary intake, exercise habits, and subjective variables. Participants in the two intervention groups (i.e., OxyShred and PL) will then be given dietary supplements for daily consumption, including OxyShred/PL and protein powder. Participants in all groups will complete the 4-week study and follow their usual training and nutrition habits - besides increased protein intake in the OxyShred and PL groups - along with questionnaires to assess compliance with the study protocol and potential side effects of supplementation. Following this 4-week period, participants will complete a second laboratory visit, where all baseline assessments will be repeated. The effects of group (OxyShred, PL, and control) and time (baseline, 4 weeks) will be statistically examined using linear models, along with appropriate post-hoc tests.

Eligibility Criteria

Inclusion Criteria:Between the ages of 18 and 40Non-smokerGenerally healthy based on self-report, defined as no known presence of uncontrolled disease or disorder, such as cardiovascular disease, metabolic disease, cancer, or musculoskeletal disorders; no major surgeries within the past 6 months; and no history of hypertension, coronary heart disease, angina, heart attack, stroke, or diabetes.For those taking prescription medication, no changes in medication in the last month, nor any known limitations on consumption of caffeine or other supplements/substances contained in the dietary supplement alongside current medications.Weight stable, defined as no changes in body weight greater than 4.5 kg in the past three months.Exercise-trained, defined as performing exercise at least 2 times per week, on average, for the previous 6 months. Resistance-trained, endurance-trained, and concurrently-trained individuals will be eligible.Moderate caffeine consumers, defined as an average daily intake of ~40 to 200 mg/d.Body mass between 50 and 110 kg.Body fat percentage ≥10% in males and ≥15% in females.Willingness to comply with the experimental protocol, including consumption of dietary supplements and adherence to other study procedures.Willingness to abstain from consumption from other sports supplements and weight loss supplements for the duration of the study.Exclusion Criteria:Failure to meet the aforementioned inclusion criteriaThey self-report sensitivity to caffeine or other stimulants, including feelings of nervousness, jitteriness, and shakiness following consumption of doses of caffeine used in this study (i.e., 150 to 300 mg).They are pregnant, currently trying to become pregnant, or breastfeeding.They report allergy to any ingredient or component of any of the dietary supplements.They self-report any other medical condition or consideration that the researchers believe could reasonably make participation unsafe, including the presence of a pacemaker or other electrical implant, claustrophobia, or other relevant conditions.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05619809). StuddyBuddy aggregates publicly available trial information.