Evaluation of a Supplement for Weight Management in Obese and Overweight Individuals
Condition: Overweight and Obesity; Men; Women
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this trial is to examine the effects of a novel, orally consumed dietary
      supplement (composed of naturally occurring components) on weight management and metabolic
      rate in individuals who are overweight or obese following a 12-week supplementation period.
      The investigator's primary outcome will be changes in body composition measured via dual
      energy x-ray absorptiometry (DXA), which will measure changes in fat and lean mass during the
      supplementation period. Another primary objective will be to determine whether or not the
      body mass index (BMI) changes during the supplementation period. A secondary objective of the
      study is to determine whether anthropometric measurements (waist-to-hip ratio) is altered
      following the supplementation period. Another secondary objective of this study is to
      determine whether metabolic rate (as measured in VO2 consumption at rest and during exercise)
      is changed following the supplementation period. Another secondary objective is to determine
      whether blood pressure (systolic and diastolic pressure, measured in mm Hg) and physical
      function (measured via VO2peak in mL/min/kg-1 and leg strength in kilograms) change when the
      supplement is administered over a 12-week period. Another secondary objective will determine
      how glycemic control, blood markers of inflammation and cholesterol are affected by this
      intervention.
    

Detailed description: 
      The present study is a randomized double-blind placebo controlled repeated measures design,
      with sampling of the cohorts on five separate occasions.

      Group 1: Intervention Group (n = 24) Healthy, overweight or obese physically inactive males,
      supplement, n = 12 Healthy, overweight or obese physically inactive females, supplement, n=12
      Group 2: Placebo Group (n = 24) Healthy, overweight or obese physically inactive males, no
      supplement, n = 12 Healthy, overweight or obese physically inactive females, no supplement,
      n=12

      Participants will be asked to make 5 visits.

      Day 0 (Visit 1): Eligible participants that provided informed consent will complete a medical
      screening questionnaire to determine their readiness to perform exercise. Participants will
      thus complete the SF-36 and CSEP Get Active Questionnaire form. Participant characteristics
      will then be measured. At this time, anthropometric measurements (i.e., height, weight, waist
      circumference) and a dual energy x-ray absorptiometry (DXA) measurement will be performed.
      This must be done in order to verify that the participant meets the inclusion criteria of
      being overweight. Following this screening, participants will begin the following the study
      timeline.Upon completion, participants will be randomized into one of two groups.

      Day 1 (Visit 2): Participants will arrive following an overnight fast (including no caffeine
      for 12 hours) and having abstained from any exercise for the prior 48 hours. Participants
      will enter the clinic, and rest quietly in the supine position for 25 minutes before having
      blood pressure with a non-invasive automated cuff and resting metabolic rate via metabolic
      cart measured. Following resting blood pressure and baseline metabolic rate assessment, blood
      will be drawn from an antecubital vein. Thereafter, functional metrics will be determined
      including strength (both upper and lower body muscles; and aerobic capacity (V02peak).
      Following testing, participants will be provided with a 3-day diet log (which will be
      completed every two weeks) and a pedometer.

      Day 14 (Visit 3); Participants will arrive following an overnight fast (including no caffeine
      for 12 hours) and having abstained from any exercise for the prior 24 hours. Participants
      will undergo a DXA. Blood will be drawn from an antecubital vein.

      Day 49 (Visit 4); Participants will arrive following an overnight fast (including no caffeine
      for 12 hours) and having abstained from any exercise for the prior 24 hours. Participants
      will undergo a DXA.

      Follow-up - Day 7, 21, 28, 35, 42, 56, 63, 70, 77: Participants will receive a weekly phone
      call to determine their pedometer counts for the week, and to ensure that participants are
      adhering to the supplement consumption, and to address any concerns.

      Day 84 (Visit 5); Participants will repeat Day 1 (automated blood pressure, resting and
      maximal metabolic rate, blood draw, functional metrics. Participants will return their
      pedometer and remuneration will be processed.

      Study products (active supplement vs. placebo) will be provided in a blinded fashion by
      Infinit Nutrition Canada (Windsor, Ontario). The active supplement is composed of vitamins,
      minerals and naturally occurring and plant extracts approved for consumption. Participants
      will be asked to consume 3 servings of the study product per day (7 days per week) throughout
      the 12-wk intervention period. Participants will consume 1 serving immediately before
      breakfast. Participants will be instructed to consume the supplement in a single sitting,
      with water, within 5-10 min. Participants will be instructed to record product intake in a
      diary to check compliance. Participants will also be asked to maintain the used package and
      turn it in at the check-ins as a marker of study compliance. To maintain the double-blind
      nature of the experiment, the placebo, which contains microcrystalline cellulose, will be
      matched in size, appearance, taste and caloric value

      Three day weighed food record. Participants will be asked to record everything that they
      consumed for 3 non-consecutive days: 2 week-days and either a Saturday or a Sunday. On
      completion of the food record, it will be analyzed using a commercially available
      computerized database software (Nutribase version 11.5, Cybersoft Inc., Phoenix, AZ, USA).
      Food items will be aggregated into the following categories: fruit (e.g., fresh/frozen,
      tinned, juice), vegetables (e.g., fresh/frozen, canned), dairy products (e.g., milk, yoghurt,
      cheese), breads and cereals (e.g., bread, breakfast cereal, rice, pasta), meats and
      alternatives (e.g., red meat, poultry, fish, pork, processed meat, tofu, eggs, nuts) and
      extra foods (e.g., hamburger, pizza, meat pies, chocolate, cake, ice cream, jam, biscuits,
      crackers, crisps, alcohol etc.).

      Resting metabolic rate (RMR). Participants will be asked to lay still on a bed will connected
      to a metabolic cart with an on-line gas collection system (Moxus modular oxygen uptake
      system, AEI Technologies, Pittsburgh, PA), and the system will acquire oxygen consumption
      (VO2) and carbon dioxide (CO2) production data for 15 minutes.

      Blood sampling. A total of ~16 mL blood per visit will be taken from the antecubital vein and
      drawn into evacuated tubes with heparin used for plasma collection and non-treated tubes will
      be used to collect serum. Blood sampling will be used for the following panel of tests:
      complete blood count (CBC), glucose, Gamma-Glutamyl Transferase (GGT), bilirubin, Alanine
      Aminotransferase (ALT), creatine kinase (CK), creatinine, triglycerides, total cholesterol,
      LDL and HDL, insulin, CRP, and leptin.

      Maximal voluntary VO2peak fitness test. Participants will complete double-leg incremental
      peak oxygen uptake (VO2peak) tests on a cycle ergometer (Lode, Groningen, the Netherlands). A
      metabolic cart with an on-line gas collection system (Moxus modular oxygen uptake system, AEI
      Technologies, Pittsburgh, PA) will acquire oxygen consumption (VO2) and carbon dioxide (CO2)
      production data. For double-leg cycling, the test will begin with a 1-min warm up at 50 watts
      (W), after which the power will be increased by 1 W every two seconds until volitional
      exhaustion or the point at which pedal cadence falls below 60 rpm. Heart rate will be
      monitored continuously throughout the test via telemetry with a heart rate monitor (Polar A3,
      Lake Success, NY). VO2peak will be defined as the highest oxygen consumption achieved over a
      30-s period. Maximal workload (Wmax) will be the highest power output achieved during the
      test. After the completion of the test, the participant will be asked to perform a 2-3-minute
      active recovery pedaling against no resistance.

      Pedometer. Participants will be given a wearable activity tracker (pedometer). All
      participants will record their daily totals for subsequent analysis.

      Dual X-ray absorptiometry (DXA) and blood pressure. A DXA scan is a non-invasive procedure
      requiring the participant to only lay still on a padded table. It is a fast procedure that
      provides a variety of body composition variables (bone mass/area/density, fat mass, and fat
      free mass). The DXA scan exposes individuals to low levels of radiation, approximately 0.18
      millirem. According to the United States Nuclear Regulatory Commission, Americans receive
      approximately 620 millirem each year, half of which is due to environmental background
      radiation. Radiation exposure can be due to medical treatments or procedures, like X-Ray or
      MRI's, food, sun exposure, etc. Any exposure to radiation can increase the risk of cancer. In
      the present study, body composition will be assessed using DXA scan (GE Lunar Prodigy,
      Madison, WI) and a software program for adults (encore Version 9.15.010). Fat free mass
      (FFM), fat mass (FM) and bone mineral density (BMD) of the entire body will be recorded.
      Arterial blood pressure (i.e., systolic [SBP] and diastolic [DBP]) will be measured during
      rest with a stethoscope (Marshall Nurse Stethoscope, Riverside, Ill., USA) and
      sphygmomanometer (MDF Instruments Direct Inc., Agoura Hills, Calif., USA).

      Waist and hip circumference measures. For waist circumference measurement, the participant
      will stand with arms at the sides, feet together, and abdomen relaxed. Using a Gulick tape
      measure, a horizontal measure will be taken at the narrowest part of the torso (above the
      umbilicus and below the xiphoid process). Obtaining a horizontal measure directly above the
      iliac crest enhances standardization according to The National Obesity Task Force. For hip
      circumference measurement, the participant stands erect and feet together, a horizontal
      measure is taken at the maximal circumference of buttocks.

      Leg press 1RM. Assessment procedures for determining lower body strength using leg press
      exercise equipment (Cybex Eagle ®, Medway, MA) will require the participant to sit in the leg
      press machine with the right foot and left foot on the weight platform. The seat and back pad
      will be adjusted so that feet are flat on the platform hip-width apart, toes slightly angled
      out, and legs parallel to each other. The interviewer will then instruct the participant to
      grasp the handles or sides of the seat and extend their legs leaving just a slight bend in
      the knee. Next, the participant will remove the racking mechanism from the platform and grasp
      the handles or seat again. The participant will begin with a selected weight that is within
      their perceived ability, approximately 60 to 80% of maximum capacity (make an educated
      guess). The participant will lower the platform slowly and controlled towards the chest,
      keeping the hips and buttocks on the seat, and the back flat against the back pad. Once the
      thighs are parallel to the platform the participant will extend the legs, pushing the weight
      back to the start position as hard and as fast as possible. The participant will be
      instructed to not allow their hips to shift to one side, the buttocks to rise, or knees to
      move inward or outward during this exercise. The interviewer will also instruct the
      participant to keep heels flat and not allow the knees to go beyond the toes. Once the
      repetitions are completed, the participant will replace the racking mechanism and exit the
      leg press. These procedures were adapted from procedures described by the National Strength
      and Condition Association (2008) and the American College of Sports Medicine (2013).

      Hand grip strength (MVIC; maximum voluntary isometric contraction). Hand grip strength will
      be measured using an isometric dynamometer (JAMAR®, Sammons, Bolingbrook, IL). The grip width
      will be adjusted to hand size and with arm flexed at 90°, the participant will perform three
      X 5 s efforts with a one min rest between trials.

      Knee extension (MVIC;maximum voluntary isometric contraction). Isometric knee extension will
      be measured by mechanical dynamometry (Biodex System 3, Biodex Medical Systems, Shirley, NY).
      Participants will be positioned into the machine with the knee flexed at 90° and perform
      three X 5s maximal voluntary contractions with 30s rest between each trial.

      Questionnaires. The RAND 36-Item Health Survey (Version 1.0) taps eight health concepts:
      physical functioning, bodily pain, role limitations due to physical health problems, role
      limitations due to personal or emotional problems, emotional well-being, social functioning,
      energy/fatigue, and general health perceptions. It also includes a single item that provides
      an indication of perceived change in health. The Get Active Questionnaire by CSEP is a
      2-page, self-administered, pre-participation for exercise screening tool. Potential
      participants must answer 'no' to all questions on the Get Active Questionnaire.
    

Intervention name(s): Active Supplement; Placebo supplement
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Examine the effects of a multi-faceted supplement comprised of vitamins, minerals and naturally occurring and plant extracts approved for consumption of in overweight/obese men and women; Examine the effects of a placebo supplement in overweight/obese men and women, compare to the active supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment