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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

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:

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.

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

NCT ID

NCT04761406

First Posted

February 8, 2021

Last Updated

February 23, 2023

Sponsor

Microphyt

Collaborators

Texas A&M University

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

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

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

jonathan.maury@microphyt.eu

First Name & Middle Initial & Last Name or Official Title & Degree

Ilya Zhivkovich

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

rbkreider@tamu.edu

First Name & Middle Initial & Last Name & Degree

Richard B. Kreider, PhD

12. IPD Sharing Statement

Plan to Share IPD

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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