NCT04761406

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Microphyt · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2021-04-26
• Primary completion: 2023-05-01
• Completion: 2023-11-01
• First posted: 2021-02-18
• Last updated: 2023-11-08

Locations

1 site across 1 country: United States