NCT05619809

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 17, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

January 17, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

4 months

First QC Date

November 9, 2022

Last Update Submit

October 9, 2023

Conditions

Body Composition ChangesBody Weight ChangesAnthropometric ChangesMetabolism ChangesHemodynamic Changes

Outcome Measures

Primary Outcomes (7)

  • Total body fat percentage

    Total body fat percentage from dual-energy x-ray absorptiometry

    4 weeks

  • Segmental body fat percentage

    Segmental body fat percentage from dual-energy x-ray absorptiometry

    4 weeks

  • Total fat mass

    Total fat mass from dual-energy x-ray absorptiometry

    4 weeks

  • Segmental fat mass

    Segmental fat mass from dual-energy x-ray absorptiometry

    4 weeks

  • Waist circumference

    Waist circumference from 3-dimensional optical imaging

    4 weeks

  • Waist-to-hip ratio

    Waist-to-hip ratio from 3-dimensional optical imaging

    4 weeks

  • Body mass

    Body mass from scale

    4 weeks

Secondary Outcomes (12)

  • Resting energy expenditure

    4 weeks

  • Respiratory quotient

    4 weeks

  • Resting heart rate

    4 weeks

  • Resting blood pressure

    4 weeks

  • Sleep quality

    4 weeks

  • +7 more secondary outcomes

Study Arms (3)

Thermogenic Dietary Supplement

EXPERIMENTAL

Arm in which the thermogenic dietary supplement is consumed.

Dietary Supplement: Thermogenic dietary supplementDietary Supplement: Protein supplement

Placebo Dietary Supplement

PLACEBO COMPARATOR

Arm in which the placebo supplement is consumed.

Dietary Supplement: Protein supplementDietary Supplement: Placebo supplement

Control

NO INTERVENTION

Control arm with no intervention.

Interventions

Thermogenic dietary supplementDIETARY_SUPPLEMENT

Daily ingestion of OxyShred thermogenic dietary supplement.

Thermogenic Dietary Supplement
Protein supplementDIETARY_SUPPLEMENT

Daily ingestion of protein supplement.

Placebo Dietary SupplementThermogenic Dietary Supplement
Placebo supplementDIETARY_SUPPLEMENT

Daily ingestion of a placebo dietary supplement.

Placebo Dietary Supplement

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between the ages of 18 and 40
  • Non-smoker
  • Generally 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.

You may not qualify if:

  • They 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Kinesiology & Sport Management

Lubbock, Texas, 79409, United States

Location

MeSH Terms

Conditions

Body Weight Changes

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2022

First Posted

November 17, 2022

Study Start

January 17, 2023

Primary Completion

May 15, 2023

Study Completion

May 15, 2023

Last Updated

October 10, 2023

Record last verified: 2023-10

Locations

US(1)