- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04761406
Microalgae Extract Phaeosol Combined to Exercise in Healthy Overweight Women : Efficacy on Body Weight Management (PHAEOSOL-ONE)
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 Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jonathan MAURY, PhD
- Phone Number: +33 611150394
- Email: jonathan.maury@microphyt.eu
Study Contact Backup
- Name: Ilya Zhivkovich
- Email: ilya.zhivkovich@microphyt.eu
Study Locations
-
-
Texas
-
College Station, Texas, United States, 77843-4253
- Exercise & Sport Nutrition Lab
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Phaeosol group
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
|
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. |
Placebo Comparator: Placebo group
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
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body fat mass (in Kg)
Time Frame: 6 and 12 weeks
|
Difference in body fat mass (kg) evaluated by DEXA between weeks 6 and 12 compared to baseline.
|
6 and 12 weeks
|
Body fat mass (in % of total body weight)
Time Frame: 6 and 12 weeks
|
Difference in body fat mass (% of total body weight) evaluated by DEXA between weeks 6 and 12 compared to baseline
|
6 and 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total body weight (Kg)
Time Frame: 6 and 12 weeks
|
Difference in total body weight between weeks 6 and 12 weeks compared to baseline
|
6 and 12 weeks
|
Waist circumference (cm)
Time Frame: 6 and 12 weeks
|
Difference in waist circumference between weeks 6 and 12 weeks compared to baseline
|
6 and 12 weeks
|
Hip circumference (cm)
Time Frame: 6 and 12 weeks
|
Difference in hip circumference between weeks 6 and 12 weeks compared to baseline
|
6 and 12 weeks
|
Resting energy expenditure (Kcal/day)
Time Frame: 6 and 12 weeks
|
Difference in resting energy expenditure between weeks 6 and 12 weeks compared to baseline
|
6 and 12 weeks
|
Maximum oxygen uptake (ml/kg/min)
Time Frame: 6 and 12 weeks
|
Difference in aerobic capacity between weeks 6 and 12 weeks compared to baseline
|
6 and 12 weeks
|
Muscle strenght - 1 Repetition Maximum (Kg)
Time Frame: 6 and 12 weeks
|
Difference in estimated 1RM between weeks 6 and 12 weeks compared to baseline
|
6 and 12 weeks
|
Muscle strenght - 1 Repetition Maximum (% of estimated)
Time Frame: 6 and 12 weeks
|
Difference in estimated 1RM between weeks 6 and 12 weeks compared to baseline
|
6 and 12 weeks
|
Muscular endurance total work (Kg)
Time Frame: 6 and 12 weeks
|
Difference in muscular endurance total work between weeks 6 and 12 weeks compared to baseline
|
6 and 12 weeks
|
Energy daily intake (Kcal/day)
Time Frame: 6 and 12 weeks
|
Difference in energy and macronutrient intake between weeks 6 and 12 weeks compared to baseline
|
6 and 12 weeks
|
Blood HDL-cholesterol level (g/l)
Time Frame: 6 and 12 weeks
|
Difference in blood HDL-cholesterol level between weeks 6 and 12 weeks compared to baseline
|
6 and 12 weeks
|
Blood LDL-cholesterol level (g/l)
Time Frame: 6 and 12 weeks
|
Difference in blood LDL-cholesterol level between weeks 6 and 12 weeks compared to baseline
|
6 and 12 weeks
|
Blood total cholesterol level (g/l)
Time Frame: 6 and 12 weeks
|
Difference in blood total cholesterol level between weeks 6 and 12 weeks compared to baseline
|
6 and 12 weeks
|
Blood TGL level (g/l)
Time Frame: 6 and 12 weeks
|
Difference in blood TGL level between weeks 6 and 12 weeks compared to baseline
|
6 and 12 weeks
|
blood TNFa level (pg/ml)
Time Frame: 6 and 12 weeks
|
Difference in blood TNFa level weeks 6 and 12 weeks compared to baseline
|
6 and 12 weeks
|
blood INF level (pg/ml)
Time Frame: 6 and 12 weeks
|
Difference in blood INF level weeks 6 and 12 weeks compared to baseline
|
6 and 12 weeks
|
blood IL6 level (pg/ml)
Time Frame: 6 and 12 weeks
|
Difference in blood IL6 level weeks 6 and 12 weeks compared to baseline
|
6 and 12 weeks
|
blood CRPhs level (pg/ml)
Time Frame: 6 and 12 weeks
|
Difference in blood CRPhs level weeks 6 and 12 weeks compared to baseline
|
6 and 12 weeks
|
Blood insulin level (mUI/l)
Time Frame: 6 and 12 weeks
|
Difference in blood insulin level between weeks 6 and 12 weeks compared to baseline
|
6 and 12 weeks
|
Blood glucose level (mmol/l)
Time Frame: 6 and 12 weeks
|
Difference in blood glucose level between weeks 6 and 12 weeks compared to baseline
|
6 and 12 weeks
|
Blood leptin level (ng/ml)
Time Frame: 6 and 12 weeks
|
Difference in blood leptin level between weeks 6 and 12 weeks compared to baseline
|
6 and 12 weeks
|
Blood HbA1C level (%)
Time Frame: 6 and 12 weeks
|
Difference in blood HbA1C level between weeks 6 and 12 weeks compared to baseline
|
6 and 12 weeks
|
Blood Creatinine level (umol/l)
Time Frame: 6 and 12 weeks
|
Difference in blood Creatinine level between weeks 6 and 12 weeks compared to baseline
|
6 and 12 weeks
|
Blood total protein level (mmol/l)
Time Frame: 6 and 12 weeks
|
Difference in blood total protein level between weeks 6 and 12 weeks compared to baseline
|
6 and 12 weeks
|
Blood Urea/BUN ratio (mmol/l)
Time Frame: 6 and 12 weeks
|
Difference in blood Urea/BUN ratio between weeks 6 and 12 weeks compared to baseline
|
6 and 12 weeks
|
Blood Uric acid level (umol/l)
Time Frame: 6 and 12 weeks
|
Difference in blood uric acid level between weeks 6 and 12 weeks compared to baseline
|
6 and 12 weeks
|
Blood AST level (U/l)
Time Frame: 6 and 12 weeks
|
Difference in blood AST level between weeks 6 and 12 weeks compared to baseline
|
6 and 12 weeks
|
Blood ALT level (U/l)
Time Frame: 6 and 12 weeks
|
Difference in blood ALT level between weeks 6 and 12 weeks compared to baseline
|
6 and 12 weeks
|
Quality of life score (SF-36)
Time Frame: 6 and 12 weeks
|
Difference in quality of life score between weeks 6 and 12 weeks compared to baseline
|
6 and 12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Richard B. Kreider, Exercise & Sport Nutrition Lab - Texas A&M University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB2020-1443
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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