Chronic Thermogenic Dietary Supplement Consumption

Body Weight Changes Clinical Trial

Official title:

Chronic Thermogenic Dietary Supplement Consumption: Effects on Body Composition, Anthropometrics, Metabolism, and Subjective Variables

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05619809
• Other study ID #: IRB2022-933
• Status: Completed
• Phase: N/A
• Start date: January 17, 2023
• Est. completion date: May 15, 2023

Study information

• Verified date: October 2023
• Source: Texas Tech University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Overview. 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. Participants. Eligible participants who provide consent will be stratified based on exercise training (resistance-trained, endurance-trained, or concurrently-trained), sex (male and female), and body composition (males: 10 to 20% vs. >20%; females: 15 to 25% vs. >25%), then randomly assigned to one of the three experimental groups (OxyShred, PL, or control) in a 2:2:1 ratio. Based on preliminary power analysis and comparison with previous studies, the target sample size is 50 participants (20 Oxyshred, 20 PL, and 10 control), with approximately equal representation of males and females. Laboratory Visits. Participants will report to the laboratory at baseline and after 4 weeks of the assigned intervention. At both laboratory visits, participants will be interviewed to confirm adherence with pre-testing guidelines, such as fasting overnight and abstaining from food and fluid ingestion. Participants will then undergo body composition testing using the methods listed below. Anthropometric variables, such as waist circumference and wasit:hip ratio, will be collected via 3-dimensional optical scanning. Resting energy expenditure and substrate oxidation (respiratory quotient) will be assessed using indirect calorimetry, and resting heart rate and blood pressure will be quantified using an automated blood pressure monitor. Questionnaires will be used to assess physical activity levels, sleep, mood, and hunger related variables. The specific body composition assessment methods to be used are ADP (air displacement plethysmography), DXA (dual-energy x-ray absorptiometry), several bioelectrical impedance techniques, several 3-dimensional scanning techniques, ultrasound, and standard assessments of height and weight. All equipment will be calibrated as recommended by the device manufacturers each day prior to use. Metabolism will be assessed using indirect calorimetry. For the on-site surveys, the following questionnaires/surveys will be used: Demographics, Exercise Habits, and Caffeine Questionnaire; the International Physical Activity Questionnaire (IPAQ); the Pittsburgh Sleep Quality Index; the Mood and Feelings Questionnaire; the Three-Factor Eating Questionnaire (R18); ASA24; and menstrual cycle questionnaire for female participants. For the daily online compliance surveys, one of two forms will be used, depending on the group assignment of the participant. Intervention. Participants randomized to the control group will be asked to continue their normal exercise and nutrition habits without making any modification for the duration of the study. However, as an incentive and to promote equity between conditions, control group participants will receive the protein supplement provided to the other groups after completion of the study. Participants in the OxyShred and PL group will be provided their assigned supplement (OxyShred or PL powder) along with supplemental protein, all provided by EHP labs. Oxyshred is a commercially available product, and the placebo will include the same flavoring agents and ingredients but without the active ingredients. The protein product is also commercially available. Participants will be asked to consume one dose of the OxyShred/PL supplement for the first week, either upon waking or 15 minutes prior to exercise, as indicated on product directions. After the first week, participants will be asked to consume two doses per day, one upon waking and one 15 minutes prior to exercise, which is also according to product directions. On days exercise is not performed, participants will be asked to consume one dose upon waking and a second dose in the early afternoon. Protein supplements will be provided to support body composition improvements. Participants with a baseline body mass between 50 and 59.9 kg will be asked to consume one serving (providing ~25 g protein) per day; participants with a baseline body mass between 60 and 89.9 kg will be asked to consume two servings per day (providing ~50 g protein); and participants with a baseline body mass between 90 and 110 kg will be asked to consume three servings per day (providing ~75 g protein). Besides the OxyShred/PL and protein supplementation, participants in the OxyShred and PL groups will be asked to generally continue their normal nutritional practices, including the types of foods they eat and eating frequency. However, all participants will be asked to refrain from consuming additional sports supplements and weight loss supplements throughout the trial. Consumption of general health support supplements, such as multivitamins, will be allowed if they were regularly consumed prior to study commencement (typically for ≥1 month). Daily caffeine intake, beyond that provided by the supplements, will be limited to ~100 mg per day, and participants will be provided with information about quantities of common foods or beverages providing this amount (e.g., one cup of coffee, two diet sodas, etc.). Throughout the intervention, compliance and potential side effects will be monitored via questionnaire. All participants will be asked to continue their typical exercise regimen and complete questionnaires documenting their frequency, duration, and type of exercise sessions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: May 15, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Between the ages of 18 and 40

2. Non-smoker

3. 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.

4. 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.

5. Weight stable, defined as no changes in body weight greater than 4.5 kg in the past three months.

6. 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.

7. Moderate caffeine consumers, defined as an average daily intake of ~40 to 200 mg/d.

8. Body mass between 50 and 110 kg.

9. Body fat percentage =10% in males and =15% in females.

10. Willingness to comply with the experimental protocol, including consumption of dietary supplements and adherence to other study procedures.

11. Willingness to abstain from consumption from other sports supplements and weight loss supplements for the duration of the study.

Exclusion Criteria:

1. Failure to meet the aforementioned inclusion criteria

2. 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).

3. They are pregnant, currently trying to become pregnant, or breastfeeding.

4. They report allergy to any ingredient or component of any of the dietary supplements.

5. 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.

Related Conditions & MeSH terms

• Body Weight
• Body Weight Changes

Intervention

Dietary Supplement:
• Thermogenic dietary supplement
Daily ingestion of OxyShred thermogenic dietary supplement.
• Protein supplement
Daily ingestion of protein supplement.
• Placebo supplement
Daily ingestion of a placebo dietary supplement.

Locations

Country	Name	City	State
United States	Department of Kinesiology & Sport Management	Lubbock	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Texas Tech University	EHP Labs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total body fat percentage	Total body fat percentage from dual-energy x-ray absorptiometry	4 weeks
Primary	Segmental body fat percentage	Segmental body fat percentage from dual-energy x-ray absorptiometry	4 weeks
Primary	Total fat mass	Total fat mass from dual-energy x-ray absorptiometry	4 weeks
Primary	Segmental fat mass	Segmental fat mass from dual-energy x-ray absorptiometry	4 weeks
Primary	Waist circumference	Waist circumference from 3-dimensional optical imaging	4 weeks
Primary	Waist-to-hip ratio	Waist-to-hip ratio from 3-dimensional optical imaging	4 weeks
Primary	Body mass	Body mass from scale	4 weeks
Secondary	Resting energy expenditure	Resting energy expenditure from indirect calorimetry	4 weeks
Secondary	Respiratory quotient	Respiratory quotient from indirect calorimetry	4 weeks
Secondary	Resting heart rate	Resting heart rate from automated sphygmomanometer	4 weeks
Secondary	Resting blood pressure	Resting blood pressure from automated sphygmomanometer	4 weeks
Secondary	Sleep quality	Sleep quality as assessed by the Pittsburgh Sleep Quality Index	4 weeks
Secondary	Mood ratings	Mood ratings as assessed by the Mood and Feelings Questionnaire	4 weeks
Secondary	Eating behaviors	Eating behaviors as assessed by the Three-Factor Eating Questionnaire	4 weeks
Secondary	Dietary intake	Dietary intake as assessed by the ASA24 recall method	4 weeks
Secondary	Total lean soft tissue	Total lean soft tissue from dual-energy x-ray absorptiometry	4 weeks
Secondary	Segmental lean soft tissue	Segmental lean soft tissue from dual-energy x-ray absorptiometry	4 weeks
Secondary	Limb circumferences	Limb circumferences from 3-dimensional optical imaging	4 weeks
Secondary	Side effects	Self-reported side effects	4 weeks