Ignite Creation Date:
2024-05-06 @ 3:49 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04761406
Status:
COMPLETED
Last Update Posted:
2023-11-08
First Post:
2021-02-08
Brief Title:
Microalgae Extract Phaeosol Combined to Exercise in Healthy Overweight Women Efficacy on Body Weight Management
Sponsor:
Microphyt
Organization:
Microphyt
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PHAEOSOL-ONE
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 20 Fucoxanthin FX content by adding a food grade medium-chain triglyceride MCT-oil and a tocopherol-rich Vitamin E extract 05 ww 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 mgpersonday for a maximal duration of 30 days of PhaeoSOL equivalent to 10 mg fucoxanthinpersonday 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 crunchcurl 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 10000 steps per day of brisk walking on non-training days goal 100 minwk of moderate to vigorous exercise Training will be recorded on training logs and by using an iPhone Fitbit or pedometer
Participants will be given 1400 1500 kcalday or 1600 kcalday diets based on resting energy expenditure determination designed to promote a 400-500 kcald 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 eg 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
Participants will be given 1400 1500 kcalday or 1600 kcalday diets based on resting energy expenditure determination designed to promote a 400-500 kcald 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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None