Chronic Thermogenic Dietary Supplement Consumption
Condition: Body Composition Changes; Body Weight Changes; Anthropometric Changes; Metabolism Changes; Hemodynamic Changes
MeSH terms: Body Weight; Body Weight Changes
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Thermogenic dietary supplement; Protein supplement; Placebo supplement
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Daily ingestion of OxyShred thermogenic dietary supplement.; Daily ingestion of protein supplement.; Daily ingestion of a placebo dietary supplement.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment