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

Primary Purpose

Overweight and Obesity, Body Weight Changes, Healthy Lifestyle

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Phaeosol group
Placebo group
Sponsored by
Microphyt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight and Obesity focused on measuring Fucoxanthin, Weight management, Microalgae, Exercise, Overweight

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Exercise & Sport Nutrition LabRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Phaeosol group

Placebo group

Arm 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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 8, 2021
Last Updated
February 23, 2023
Sponsor
Microphyt
Collaborators
Texas A&M University
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1. Study Identification

Unique Protocol Identification Number
NCT04761406
Brief Title
Microalgae Extract Phaeosol Combined to Exercise in Healthy Overweight Women : Efficacy on Body Weight Management
Acronym
PHAEOSOL-ONE
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2021 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
May 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Microphyt
Collaborators
Texas A&M University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Body Weight Changes, Healthy Lifestyle, Exercise, Dietary Supplement
Keywords
Fucoxanthin, Weight management, Microalgae, Exercise, Overweight

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, placebo controlled, double-blind, parallel arm intervention trial.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Has given voluntary, written, informed consent to participate in the study; Healthy pre-menopausal females age 18 - 50 years; 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. Free-living (living in a private home, alone or with family, and able to maintain their health and hygiene without assistance); In generally good health; and, 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: Are pregnant, breastfeeding, or wish to become pregnant during the study; Plan major changes in lifestyle (i.e. diet, dieting, exercise level, travel) during the study; Have a recent history (<3 months) of exercise training or weight loss (> 5%); Have an orthopedic limitation that would prevent participation in a general fitness program; Have uncontrolled heart disease, hypertension, diabetes, thyroid disease, cancer, neurological disease, or untreated psychotic or major depressive disorder; Have taken weight loss dietary supplements or medications during the last 4-wks; Have a history of chronic use of oral or injectable corticosteroids; Have a history within previous 12 months of alcohol or substance abuse; Are a heavy smoking (>1 pack/day within past 3 months); Have a history of heavy caffeinated beverage consumption (>400mg caffeine/day) within past 2 weeks; or, Have known allergy to any of the ingredients in the supplement product or placebo.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan MAURY, PhD
Phone
+33 611150394
Email
jonathan.maury@microphyt.eu
First Name & Middle Initial & Last Name or Official Title & Degree
Ilya Zhivkovich
Email
ilya.zhivkovich@microphyt.eu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard B. Kreider
Organizational Affiliation
Exercise & Sport Nutrition Lab - Texas A&M University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Exercise & Sport Nutrition Lab
City
College Station
State/Province
Texas
ZIP/Postal Code
77843-4253
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard B. Kreider, PhD
Phone
636-627-4629
Email
rbkreider@tamu.edu
First Name & Middle Initial & Last Name & Degree
Richard B. Kreider, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33993853
Citation
Yang M, Xuan Z, Wang Q, Yan S, Zhou D, Naman CB, Zhang J, He S, Yan X, Cui W. Fucoxanthin has potential for therapeutic efficacy in neurodegenerative disorders by acting on multiple targets. Nutr Neurosci. 2022 Oct;25(10):2167-2180. doi: 10.1080/1028415X.2021.1926140. Epub 2021 May 15.
Results Reference
derived

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

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