Microalgae Extract Phaeosol Combined to Exercise in Healthy Overweight Women : Efficacy on Body Weight Management

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of a Microalgae Extract PhaeoSOL on Optimizing the Benefits of Healthy, Overweight and Moderately Obese Women Participating in an Exercise and Weight Management Program.

Conditions
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Overweight and Obesity, Body Weight Changes, Healthy Lifestyle, Exercise, Dietary Supplement

Intervention / Treatment
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* Dietary Supplement: Phaeosol group
* Dietary Supplement: Placebo group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has given voluntary, written, informed consent to participate in the study; Healthy pre-menopausal females age 18 - 50 years; Body mass index (BMI) between 25 - 35 kg/m2 and/or body fat >30%; preferred BMI between 25-32 kg/m2; mean BMI in each group has to be in the range of 25-29.9. Free-living (living in a private home, alone or with family, and able to maintain their health and hygiene without assistance); In generally good health; and, Willing to maintain consistent sleep duration the evening before study visits. Mean average BMI will be controlled during phone screening. Anyone with a BMI from 25-29.9 (assuming other inclusion criteria are met with no exclusion criteria) will be enrolled and a list of alternatives for borderline subjects will be kept (e.g. up to 32). A log of active participants will be kept so subjects above 30 will not be added unless the mean is within 25-29.9 range Exclusion Criteria: Are pregnant, breastfeeding, or wish to become pregnant during the study; Plan major changes in lifestyle (i.e. diet, dieting, exercise level, travel) during the study; Have a recent history (<3 months) of exercise training or weight loss (> 5%); Have an orthopedic limitation that would prevent participation in a general fitness program; Have uncontrolled heart disease, hypertension, diabetes, thyroid disease, cancer, neurological disease, or untreated psychotic or major depressive disorder; Have taken weight loss dietary supplements or medications during the last 4-wks; Have a history of chronic use of oral or injectable corticosteroids; Have a history within previous 12 months of alcohol or substance abuse; Are a heavy smoking (>1 pack/day within past 3 months); Have a history of heavy caffeinated beverage consumption (>400mg caffeine/day) within past 2 weeks; or, Have known allergy to any of the ingredients in the supplement product or placebo.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, placebo controlled, double-blind, parallel arm intervention trial.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phaeosol group<br>Daily supplementation of Phaeosol softgel capsule (218mg/d), active ingredients of Microphyt. Each randomized subject will consume 1 softgel capsule (before breakfast) per day during 12 weeks | Dietary Supplement: Phaeosol group<br>* 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.<br>|
| Placebo Comparator: Placebo group<br>Daily supplementation of placebo softgel capsule (218mg/d of 100% sunflower oil) with the same appearance and packaging than experimental product. Each randomized subject will consume 1 softgel capsule (before breakfast) per day during 12 weeks | Dietary Supplement: Placebo group<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body fat mass (in Kg) | Difference in body fat mass (kg) evaluated by DEXA between weeks 6 and 12 compared to baseline. | 6 and 12 weeks | 
| Body fat mass (in % of total body weight) | Difference in body fat mass (% of total body weight) evaluated by DEXA between weeks 6 and 12 compared to baseline | 6 and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total body weight (Kg) | Difference in total body weight between weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks | 
| Waist circumference (cm) | Difference in waist circumference between weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks | 
| Hip circumference (cm) | Difference in hip circumference between weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks | 
| Resting energy expenditure (Kcal/day) | Difference in resting energy expenditure between weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks | 
| Maximum oxygen uptake (ml/kg/min) | Difference in aerobic capacity between weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks | 
| Muscle strenght - 1 Repetition Maximum (Kg) | Difference in estimated 1RM between weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks | 
| Muscle strenght - 1 Repetition Maximum (% of estimated) | Difference in estimated 1RM between weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks | 
| Muscular endurance total work (Kg) | Difference in muscular endurance total work between weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks | 
| Energy daily intake (Kcal/day) | Difference in energy and macronutrient intake between weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks | 
| Blood HDL-cholesterol level (g/l) | Difference in blood HDL-cholesterol level between weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks | 
| Blood LDL-cholesterol level (g/l) | Difference in blood LDL-cholesterol level between weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks | 
| Blood total cholesterol level (g/l) | Difference in blood total cholesterol level between weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks | 
| Blood TGL level (g/l) | Difference in blood TGL level between weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks | 
| blood TNFa level (pg/ml) | Difference in blood TNFa level weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks | 
| blood INF level (pg/ml) | Difference in blood INF level weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks | 
| blood IL6 level (pg/ml) | Difference in blood IL6 level weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks | 
| blood CRPhs level (pg/ml) | Difference in blood CRPhs level weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks | 
| Blood insulin level (mUI/l) | Difference in blood insulin level between weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks | 
| Blood glucose level (mmol/l) | Difference in blood glucose level between weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks | 
| Blood leptin level (ng/ml) | Difference in blood leptin level between weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks | 
| Blood HbA1C level (%) | Difference in blood HbA1C level between weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks | 
| Blood Creatinine level (umol/l) | Difference in blood Creatinine level between weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks | 
| Blood total protein level (mmol/l) | Difference in blood total protein level between weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks | 
| Blood Urea/BUN ratio (mmol/l) | Difference in blood Urea/BUN ratio between weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks | 
| Blood Uric acid level (umol/l) | Difference in blood uric acid level between weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks | 
| Blood AST level (U/l) | Difference in blood AST level between weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks | 
| Blood ALT level (U/l) | Difference in blood ALT level between weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks | 
| Quality of life score (SF-36) | Difference in quality of life score between weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fucoxanthin, Weight management, Microalgae, Exercise, Overweight