Clinical trial NCT04761406: Microalgae Extract Phaeosol Combined to Exercise in Healthy Overweight Women : Efficacy on Body Weight Management
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
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Body Weight Changes
Healthy Lifestyle
Exercise
Dietary Supplement
Keywords: Fucoxanthin
Weight management
Microalgae
Exercise
Overweight
Lead sponsor: Microphyt
Sponsor class: INDUSTRY
Collaborators: name: Texas A&M University
First posted: 2021-02-18
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, placebo controlled, double-blind, parallel arm intervention trial.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Body fat mass (in Kg)
timeFrame: 6 and 12 weeks
measure: Body fat mass (in % of total body weight)
timeFrame: 6 and 12 weeks
Secondary outcomes:
measure: Total body weight (Kg)
timeFrame: 6 and 12 weeks
measure: Waist circumference (cm)
timeFrame: 6 and 12 weeks
measure: Hip circumference (cm)
timeFrame: 6 and 12 weeks
measure: Resting energy expenditure (Kcal/day)
timeFrame: 6 and 12 weeks
measure: Maximum oxygen uptake (ml/kg/min)
timeFrame: 6 and 12 weeks
measure: Muscle strenght - 1 Repetition Maximum (Kg)
timeFrame: 6 and 12 weeks
measure: Muscle strenght - 1 Repetition Maximum (% of estimated)
timeFrame: 6 and 12 weeks
measure: Muscular endurance total work (Kg)
timeFrame: 6 and 12 weeks
measure: Energy daily intake (Kcal/day)
timeFrame: 6 and 12 weeks
measure: Blood HDL-cholesterol level (g/l)
timeFrame: 6 and 12 weeks
measure: Blood LDL-cholesterol level (g/l)
timeFrame: 6 and 12 weeks
measure: Blood total cholesterol level (g/l)
timeFrame: 6 and 12 weeks
measure: Blood TGL level (g/l)
timeFrame: 6 and 12 weeks
measure: blood TNFa level (pg/ml)
timeFrame: 6 and 12 weeks
measure: blood INF level (pg/ml)
timeFrame: 6 and 12 weeks
measure: blood IL6 level (pg/ml)
timeFrame: 6 and 12 weeks
measure: blood CRPhs level (pg/ml)
timeFrame: 6 and 12 weeks
measure: Blood insulin level (mUI/l)
timeFrame: 6 and 12 weeks
measure: Blood glucose level (mmol/l)
timeFrame: 6 and 12 weeks
measure: Blood leptin level (ng/ml)
timeFrame: 6 and 12 weeks
measure: Blood HbA1C level (%)
timeFrame: 6 and 12 weeks
measure: Blood Creatinine level (umol/l)
timeFrame: 6 and 12 weeks
measure: Blood total protein level (mmol/l)
timeFrame: 6 and 12 weeks
measure: Blood Urea/BUN ratio (mmol/l)
timeFrame: 6 and 12 weeks
measure: Blood Uric acid level (umol/l)
timeFrame: 6 and 12 weeks
measure: Blood AST level (U/l)
timeFrame: 6 and 12 weeks
measure: Blood ALT level (U/l)
timeFrame: 6 and 12 weeks
measure: Quality of life score (SF-36)
timeFrame: 6 and 12 weeks
Other outcomes:
Locations:
city: College Station
country: United States
facility: Exercise & Sport Nutrition Lab
state: Texas
Study officials:
affiliation: Exercise & Sport Nutrition Lab - Texas A&M University
name: Richard B. Kreider
role: PRINCIPAL_INVESTIGATOR
References:
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.