Microalgae Extract Phaeosol Combined to Exercise in Healthy Overweight Women : Efficacy on Body Weight Management
Condition: Overweight and Obesity; Body Weight Changes; Healthy Lifestyle; Exercise; Dietary Supplement
MeSH terms: Overweight; Body Weight; Body Weight Changes
Study type: Interventional

Summary: 
      PhaoeSOL (Microphyt, Baillargues, France) is a microalgae-based nutritional ingredient
      developed with a patented production process that has New Dietary Ingredient (NDI) status
      from the FDA (#1120). It is an extract of the microalgae Phaeodactylum tricornutum
      standardized to 2.0% Fucoxanthin (FX) content by adding a food grade medium-chain
      triglyceride (MCT)-oil and a tocopherol-rich (Vitamin E) extract (0.5 % w:w). PhaeoSOL is
      intended for use as a source of the naturally occurring carotenoid, fucoxanthin, in food
      supplement products for the general population at levels not to exceed 437 mg/person/day for
      a maximal duration of 30 days of PhaeoSOL (equivalent to 10 mg fucoxanthin/person/day). Prior
      studies suggest that marine algae and Fucoxanthinol may have anti-obesity, lipid lowering,
      and glucose management enhancing properties. The purpose of this proof of concept pilot study
      is to examine whether dietary supplementation of PhaoeSOL enhances the benefits of women
      participating in an exercise and weight management program.
    

Detailed description: 
      All participants will participate in a supervised exercise training 3 days per week at the
      HCRF consisting of a 5-min warm-up, light stretching, resistance training (3 sets of 10
      repetitions @ 60%-80% 1RM on the bench press, seated row, shoulder press, lat pulldown,
      biceps curl, triceps extension, leg press, leg extension, leg curl, abdominal crunch/curl,
      back extension), and cardiovascular training (walking or cycling for 20 to 30 min training at
      60% to 80% heart rate reserve [HRR]). Additionally, participants will be asked to accumulate
      10,000 steps per day of brisk walking on non-training days (goal > 100 min./wk. of moderate
      to vigorous exercise). Training will be recorded on training logs and by using an iPhone,
      Fitbit or pedometer.

      Participants will be given 1,400, 1,500 kcal/day or 1,600 kcal/day diets based on resting
      energy expenditure determination designed to promote a 400-500 kcal/d energy intake deficit
      following the American Heart Association (AHA) macronutrient distribution recommendations
      (55% CHO, 30% FAT, 15% PRO). A goal energy intake, weekly diet plan, examples, and a food
      substitution list will be provided. A phone app (e.g., MyFoodDiary) will be used to help
      participants monitor and adhere to energy intake goals. In our prior studies, this exercise
      and diet intervention has been shown to promote a 3-5 kg fat loss, 3-5% decrease in percent
      body fat, a maintenance in fat free mass and REE, and improved health outcomes.

      Primary Endpoints: Differences in body weight, body fat mass (kg and %), and waist and hip
      circumference at weeks 6 and 12 compared to baseline.

      Secondary Endpoints: Differences in resting energy expenditure, aerobic capacity, estimated
      1RM, muscular endurance total work, training volume, energy and macronutrient intake, blood
      lipids, and HbA1c, IL6, CRPhs, TNFa, INF, Leptin, HbA1C, Insulin, Glucose, Comprehensive
      Clinical Panel (HDL, LDL, TG, BUN, CREAT, etc.), side effects, SF-36 quality of life at weeks
      6 and 12 compared to baseline.
    

Intervention name(s): Phaeosol group; Placebo group
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): In a double blind, randomized manner, 40 pre-menopausal females will ingest one of the following for 12 weeks:
Treatment 1 -Placebo (218 mg/d of 100% sunflower Oil) Treatment 2 - PhaeoSOL (218 mg/d)
Supplements will be prepared in softgel capsules for double blind administration by the sponsor.; In a double blind, randomized manner, 40 pre-menopausal females will ingest one of the following for 12 weeks:
Treatment 1 -Placebo (218 mg/d of 100% sunflower Oil) Treatment 2 - PhaeoSOL (218 mg/d)
Supplements will be prepared in softgel capsules for double blind administration by the sponsor.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, placebo controlled, double-blind, parallel arm intervention trial.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Fucoxanthin; Weight management; Microalgae; Exercise; Overweight