Effects of ISOThrive on Bodyweight, Body Composition, Hunger/Satiety and Cardiac Risk Measures in Overweight Adults
Condition: Obesity
MeSH terms: Overweight; Body Weight
Study type: Interventional

Summary: 
      To compare the effects of daily intake of the ISOThrive supplement vs. a placebo on the
      primary outcome measure of body weight and secondary outcome measures (hunger/satiety,
      health-related measures and self-reported quality of life) in a group of overweight but
      otherwise healthy adults.
    

Detailed description: 
      Hypothesis

      The investigator's hypothesize that daily intake for a 3-month period of the ISOThrive
      supplement vs. a placebo will demonstrate beneficial effects on the primary outcome measure
      of body weight and secondary outcome measures (hunger/satiety, health-related measures and
      self-reported quality of life) in a group of overweight adults.

      Specific Aims

        -  To determine the effects of the ISOThrive supplement on body weight in overweight adults
           encouraged to reduce calories and exercise regularly, but on an unrestricted diet and
           without specific exercise instruction. Specifically, to demonstrate a clinically
           meaningful reduction in body weight in a group of overweight adults after 3 months of
           daily consumption of the ISOThrive supplement.

        -  To determine the effects of the ISOThrive supplement on hunger/satiety, body
           composition, waist circumference, blood pressure, blood glucose levels, blood lipid
           levels, inflammatory and satiety serum markers and self-reported quality of life in
           overweight adults encouraged to reduce calories and exercise regularly, but on an
           unrestricted diet and without specific exercise instruction. Specifically, to
           demonstrate an improvement in hunger/satiety and a clinically meaningful improvement in
           other measures in a group of overweight adults after 3 months of daily consumption of
           the ISOThrive supplement.

        -  To demonstrate the safety of the ISOThrive supplement in terms of its impact on blood,
           liver and kidney function in overweight adults. Specifically, to demonstrate the lack of
           a negative impact on blood, liver and kidney function tests in a group of overweight
           adults after 3 months of daily consumption of the ISOThrive supplement.

        -  To determine the effects of the ISOThrive supplement on Gut health. Specifically, to
           demonstrate improvement in Gut health as measured by abdominal bloating, abdominal gas,
           and abdominal pain/discomfort at the end of 3 months of daily consumption of the
           ISOThrive supplement.
    

Intervention name(s): ISOThrive Supplement; Placebo Supplement
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Consumption of ISOThrive supplements for 3 months; Consumption of Placebo supplement (Magnesium stearate or methylcellulose) for 3 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: prebiotic; dietary supplement