College Station, Texas 77843

  • Dietary Supplement

Purpose:

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.


Study summary:

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.


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.


Study is Available At:


Original ID:

IRB2020-1443


NCT ID:

NCT04761406


Secondary ID:


Study Acronym:

PHAEOSOL-ONE


Brief Title:

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


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.


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

50 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Microphyt


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

60


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Richard B. Kreider
Principal Investigator
Exercise & Sport Nutrition Lab - Texas A&M University
Primary Contact:Jonathan MAURY, PhD
+33 611150394
jonathan.maury@microphyt.eu
Backup Contact:Ilya Zhivkovich
ilya.zhivkovich@microphyt.eu

Study Dates

Start Date:April 26, 2021
Completion Date:September 1, 2021
Completion Type:Anticipated
Primary Completion Date:September 1, 2021
Primary Completion Type:Anticipated
Verification Date:May 2021
Last Changed Date:May 3, 2021
First Received Date:February 8, 2021

Study Outcomes

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

Study Interventions

Intervention Type:Dietary Supplement
Name:Phaeosol group
Description: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.
Arm Name:Phaeosol group
Intervention Type:Dietary Supplement
Name:Placebo group
Description: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.
Arm Name:Placebo group

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo group
Description: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
Study Arm Type:Experimental
Arm Name:Phaeosol group
Description: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

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Microphyt
Agency Class:Other
Agency Type:Collaborator
Agency Name:Texas A&M University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 28, 2021

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