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

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04761406
Acronym
PHAEOSOL-ONE
Enrollment
60
Registered
2021-02-18
Start date
2021-04-26
Completion date
2023-11-01
Last updated
2023-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Fucoxanthin, Weight management, Microalgae, Exercise, Overweight

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.

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.

Interventions

DIETARY_SUPPLEMENTPhaeosol 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.

DIETARY_SUPPLEMENTPlacebo 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.

Sponsors

Texas A&M University
CollaboratorOTHER
Microphyt
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Randomized, placebo controlled, double-blind, parallel arm intervention trial.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Body fat mass (in Kg)6 and 12 weeksDifference in body fat mass (kg) evaluated by DEXA between weeks 6 and 12 compared to baseline.
Body fat mass (in % of total body weight)6 and 12 weeksDifference in body fat mass (% of total body weight) evaluated by DEXA between weeks 6 and 12 compared to baseline

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026