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| Name | Class |
|---|---|
| Texas A&M University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phaeosol group | Experimental | 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 |
|
| Placebo group | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phaeosol group | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Body fat mass (in Kg) | 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) | Difference in body fat mass (% of total body weight) evaluated by DEXA between weeks 6 and 12 compared to baseline | 6 and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Total body weight (Kg) | Difference in total body weight between weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks |
| Waist circumference (cm) | Difference in waist circumference between weeks 6 and 12 weeks compared to baseline |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Richard B. Kreider | Exercise & Sport Nutrition Lab - Texas A&M University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Exercise & Sport Nutrition Lab | College Station | Texas | 77843-4253 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38613023 | Derived | Dickerson B, Maury J, Jenkins V, Nottingham K, Xing D, Gonzalez DE, Leonard M, Kendra J, Ko J, Yoo C, Johnson S, Pradelles R, Purpura M, Jager R, Sowinski R, Rasmussen CJ, Kreider RB. Effects of Supplementation with Microalgae Extract from Phaeodactylum tricornutum (Mi136) to Support Benefits from a Weight Management Intervention in Overweight Women. Nutrients. 2024 Mar 28;16(7):990. doi: 10.3390/nu16070990. | |
| 33993853 |
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Randomized, placebo controlled, double-blind, parallel arm intervention trial.
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|
| Placebo group | Dietary Supplement | 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. |
|
| 6 and 12 weeks |
| Hip circumference (cm) | Difference in hip circumference between weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks |
| Resting energy expenditure (Kcal/day) | Difference in resting energy expenditure between weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks |
| Maximum oxygen uptake (ml/kg/min) | Difference in aerobic capacity between weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks |
| Muscle strenght - 1 Repetition Maximum (Kg) | Difference in estimated 1RM between weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks |
| Muscle strenght - 1 Repetition Maximum (% of estimated) | Difference in estimated 1RM between weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks |
| Muscular endurance total work (Kg) | Difference in muscular endurance total work between weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks |
| Energy daily intake (Kcal/day) | 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) | 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) | 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) | Difference in blood total cholesterol level between weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks |
| Blood TGL level (g/l) | Difference in blood TGL level between weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks |
| blood TNFa level (pg/ml) | Difference in blood TNFa level weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks |
| blood INF level (pg/ml) | Difference in blood INF level weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks |
| blood IL6 level (pg/ml) | Difference in blood IL6 level weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks |
| blood CRPhs level (pg/ml) | Difference in blood CRPhs level weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks |
| Blood insulin level (mUI/l) | Difference in blood insulin level between weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks |
| Blood glucose level (mmol/l) | Difference in blood glucose level between weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks |
| Blood leptin level (ng/ml) | Difference in blood leptin level between weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks |
| Blood HbA1C level (%) | Difference in blood HbA1C level between weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks |
| Blood Creatinine level (umol/l) | Difference in blood Creatinine level between weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks |
| Blood total protein level (mmol/l) | 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) | 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) | Difference in blood uric acid level between weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks |
| Blood AST level (U/l) | Difference in blood AST level between weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks |
| Blood ALT level (U/l) | Difference in blood ALT level between weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks |
| Quality of life score (SF-36) | Difference in quality of life score between weeks 6 and 12 weeks compared to baseline | 6 and 12 weeks |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D001836 | Body Weight Changes |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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