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Microalgae Extract Phaeosol Combined to Exercise in Healthy Overweight Women : Efficacy on Body Weight Management (PHAEOSOL-ONE)

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ClinicalTrials.gov Identifier: NCT04761406
Recruitment Status : Recruiting
First Posted : February 18, 2021
Last Update Posted : May 6, 2021
Sponsor:
Collaborator:
Texas A&M University
Information provided by (Responsible Party):
Microphyt

Brief 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.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Body Weight Changes Healthy Lifestyle Exercise Dietary Supplement Dietary Supplement: Phaeosol group Dietary Supplement: Placebo group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Official Title: 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.
Actual Study Start Date : April 26, 2021
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Phaeosol group
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

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.


Placebo Comparator: Placebo group
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

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.





Primary Outcome Measures :
  1. Body fat mass (in Kg) [ Time Frame: 6 and 12 weeks ]
    Difference in body fat mass (kg) evaluated by DEXA between weeks 6 and 12 compared to baseline.

  2. Body fat mass (in % of total body weight) [ Time Frame: 6 and 12 weeks ]
    Difference in body fat mass (% of total body weight) evaluated by DEXA between weeks 6 and 12 compared to baseline


Secondary Outcome Measures :
  1. Total body weight (Kg) [ Time Frame: 6 and 12 weeks ]
    Difference in total body weight between weeks 6 and 12 weeks compared to baseline

  2. Waist circumference (cm) [ Time Frame: 6 and 12 weeks ]
    Difference in waist circumference between weeks 6 and 12 weeks compared to baseline

  3. Hip circumference (cm) [ Time Frame: 6 and 12 weeks ]
    Difference in hip circumference between weeks 6 and 12 weeks compared to baseline

  4. Resting energy expenditure (Kcal/day) [ Time Frame: 6 and 12 weeks ]
    Difference in resting energy expenditure between weeks 6 and 12 weeks compared to baseline

  5. Maximum oxygen uptake (ml/kg/min) [ Time Frame: 6 and 12 weeks ]
    Difference in aerobic capacity between weeks 6 and 12 weeks compared to baseline

  6. Muscle strenght - 1 Repetition Maximum (Kg) [ Time Frame: 6 and 12 weeks ]
    Difference in estimated 1RM between weeks 6 and 12 weeks compared to baseline

  7. Muscle strenght - 1 Repetition Maximum (% of estimated) [ Time Frame: 6 and 12 weeks ]
    Difference in estimated 1RM between weeks 6 and 12 weeks compared to baseline

  8. Muscular endurance total work (Kg) [ Time Frame: 6 and 12 weeks ]
    Difference in muscular endurance total work between weeks 6 and 12 weeks compared to baseline

  9. Energy daily intake (Kcal/day) [ Time Frame: 6 and 12 weeks ]
    Difference in energy and macronutrient intake between weeks 6 and 12 weeks compared to baseline

  10. Blood HDL-cholesterol level (g/l) [ Time Frame: 6 and 12 weeks ]
    Difference in blood HDL-cholesterol level between weeks 6 and 12 weeks compared to baseline

  11. Blood LDL-cholesterol level (g/l) [ Time Frame: 6 and 12 weeks ]
    Difference in blood LDL-cholesterol level between weeks 6 and 12 weeks compared to baseline

  12. Blood total cholesterol level (g/l) [ Time Frame: 6 and 12 weeks ]
    Difference in blood total cholesterol level between weeks 6 and 12 weeks compared to baseline

  13. Blood TGL level (g/l) [ Time Frame: 6 and 12 weeks ]
    Difference in blood TGL level between weeks 6 and 12 weeks compared to baseline

  14. blood TNFa level (pg/ml) [ Time Frame: 6 and 12 weeks ]
    Difference in blood TNFa level weeks 6 and 12 weeks compared to baseline

  15. blood INF level (pg/ml) [ Time Frame: 6 and 12 weeks ]
    Difference in blood INF level weeks 6 and 12 weeks compared to baseline

  16. blood IL6 level (pg/ml) [ Time Frame: 6 and 12 weeks ]
    Difference in blood IL6 level weeks 6 and 12 weeks compared to baseline

  17. blood CRPhs level (pg/ml) [ Time Frame: 6 and 12 weeks ]
    Difference in blood CRPhs level weeks 6 and 12 weeks compared to baseline

  18. Blood insulin level (mUI/l) [ Time Frame: 6 and 12 weeks ]
    Difference in blood insulin level between weeks 6 and 12 weeks compared to baseline

  19. Blood glucose level (mmol/l) [ Time Frame: 6 and 12 weeks ]
    Difference in blood glucose level between weeks 6 and 12 weeks compared to baseline

  20. Blood leptin level (ng/ml) [ Time Frame: 6 and 12 weeks ]
    Difference in blood leptin level between weeks 6 and 12 weeks compared to baseline

  21. Blood HbA1C level (%) [ Time Frame: 6 and 12 weeks ]
    Difference in blood HbA1C level between weeks 6 and 12 weeks compared to baseline

  22. Blood Creatinine level (umol/l) [ Time Frame: 6 and 12 weeks ]
    Difference in blood Creatinine level between weeks 6 and 12 weeks compared to baseline

  23. Blood total protein level (mmol/l) [ Time Frame: 6 and 12 weeks ]
    Difference in blood total protein level between weeks 6 and 12 weeks compared to baseline

  24. Blood Urea/BUN ratio (mmol/l) [ Time Frame: 6 and 12 weeks ]
    Difference in blood Urea/BUN ratio between weeks 6 and 12 weeks compared to baseline

  25. Blood Uric acid level (umol/l) [ Time Frame: 6 and 12 weeks ]
    Difference in blood uric acid level between weeks 6 and 12 weeks compared to baseline

  26. Blood AST level (U/l) [ Time Frame: 6 and 12 weeks ]
    Difference in blood AST level between weeks 6 and 12 weeks compared to baseline

  27. Blood ALT level (U/l) [ Time Frame: 6 and 12 weeks ]
    Difference in blood ALT level between weeks 6 and 12 weeks compared to baseline

  28. Quality of life score (SF-36) [ Time Frame: 6 and 12 weeks ]
    Difference in quality of life score between weeks 6 and 12 weeks compared to baseline



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Has given voluntary, written, informed consent to participate in the study;
  2. Healthy pre-menopausal females age 18 - 50 years;
  3. 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.
  4. Free-living (living in a private home, alone or with family, and able to maintain their health and hygiene without assistance);
  5. In generally good health; and,
  6. 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:

  1. Are pregnant, breastfeeding, or wish to become pregnant during the study;
  2. Plan major changes in lifestyle (i.e. diet, dieting, exercise level, travel) during the study;
  3. Have a recent history (<3 months) of exercise training or weight loss (> 5%);
  4. Have an orthopedic limitation that would prevent participation in a general fitness program;
  5. Have uncontrolled heart disease, hypertension, diabetes, thyroid disease, cancer, neurological disease, or untreated psychotic or major depressive disorder;
  6. Have taken weight loss dietary supplements or medications during the last 4-wks;
  7. Have a history of chronic use of oral or injectable corticosteroids;
  8. Have a history within previous 12 months of alcohol or substance abuse;
  9. Are a heavy smoking (>1 pack/day within past 3 months);
  10. Have a history of heavy caffeinated beverage consumption (>400mg caffeine/day) within past 2 weeks; or,
  11. Have known allergy to any of the ingredients in the supplement product or placebo.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04761406


Contacts
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Contact: Jonathan MAURY, PhD +33 611150394 jonathan.maury@microphyt.eu
Contact: Ilya Zhivkovich ilya.zhivkovich@microphyt.eu

Locations
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United States, Texas
Exercise & Sport Nutrition Lab Recruiting
College Station, Texas, United States, 77843-4253
Contact: Richard B. Kreider, PhD    636-627-4629    rbkreider@tamu.edu   
Principal Investigator: Richard B. Kreider, PhD         
Sponsors and Collaborators
Microphyt
Texas A&M University
Investigators
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Principal Investigator: Richard B. Kreider Exercise & Sport Nutrition Lab - Texas A&M University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Microphyt
ClinicalTrials.gov Identifier: NCT04761406    
Other Study ID Numbers: IRB2020-1443
First Posted: February 18, 2021    Key Record Dates
Last Update Posted: May 6, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Microphyt:
Fucoxanthin
Weight management
Microalgae
Exercise
Overweight
Additional relevant MeSH terms:
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Body Weight
Overweight
Body Weight Changes