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

Overweight and Obesity Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04761406
• Other study ID #: IRB2020-1443
• Status: Completed
• Phase: N/A
• Start date: April 26, 2021
• Est. completion date: November 1, 2023

Study information

• Verified date: November 2023
• Source: Microphyt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Body Weight Changes
• Dietary Supplement
• Exercise
• Healthy Lifestyle
• Overweight
• Overweight and Obesity

Intervention

Dietary Supplement:
• Phaeosol group
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 group
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.

Locations

Country	Name	City	State
United States	Exercise & Sport Nutrition Lab	College Station	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Microphyt	Texas A&M University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	Total body weight (Kg)	Difference in total body weight between weeks 6 and 12 weeks compared to baseline	6 and 12 weeks
Secondary	Waist circumference (cm)	Difference in waist circumference between weeks 6 and 12 weeks compared to baseline	6 and 12 weeks
Secondary	Hip circumference (cm)	Difference in hip circumference between weeks 6 and 12 weeks compared to baseline	6 and 12 weeks
Secondary	Resting energy expenditure (Kcal/day)	Difference in resting energy expenditure between weeks 6 and 12 weeks compared to baseline	6 and 12 weeks
Secondary	Maximum oxygen uptake (ml/kg/min)	Difference in aerobic capacity between weeks 6 and 12 weeks compared to baseline	6 and 12 weeks
Secondary	Muscle strenght - 1 Repetition Maximum (Kg)	Difference in estimated 1RM between weeks 6 and 12 weeks compared to baseline	6 and 12 weeks
Secondary	Muscle strenght - 1 Repetition Maximum (% of estimated)	Difference in estimated 1RM between weeks 6 and 12 weeks compared to baseline	6 and 12 weeks
Secondary	Muscular endurance total work (Kg)	Difference in muscular endurance total work between weeks 6 and 12 weeks compared to baseline	6 and 12 weeks
Secondary	Energy daily intake (Kcal/day)	Difference in energy and macronutrient intake between weeks 6 and 12 weeks compared to baseline	6 and 12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Blood TGL level (g/l)	Difference in blood TGL level between weeks 6 and 12 weeks compared to baseline	6 and 12 weeks
Secondary	blood TNFa level (pg/ml)	Difference in blood TNFa level weeks 6 and 12 weeks compared to baseline	6 and 12 weeks
Secondary	blood INF level (pg/ml)	Difference in blood INF level weeks 6 and 12 weeks compared to baseline	6 and 12 weeks
Secondary	blood IL6 level (pg/ml)	Difference in blood IL6 level weeks 6 and 12 weeks compared to baseline	6 and 12 weeks
Secondary	blood CRPhs level (pg/ml)	Difference in blood CRPhs level weeks 6 and 12 weeks compared to baseline	6 and 12 weeks
Secondary	Blood insulin level (mUI/l)	Difference in blood insulin level between weeks 6 and 12 weeks compared to baseline	6 and 12 weeks
Secondary	Blood glucose level (mmol/l)	Difference in blood glucose level between weeks 6 and 12 weeks compared to baseline	6 and 12 weeks
Secondary	Blood leptin level (ng/ml)	Difference in blood leptin level between weeks 6 and 12 weeks compared to baseline	6 and 12 weeks
Secondary	Blood HbA1C level (%)	Difference in blood HbA1C level between weeks 6 and 12 weeks compared to baseline	6 and 12 weeks
Secondary	Blood Creatinine level (umol/l)	Difference in blood Creatinine level between weeks 6 and 12 weeks compared to baseline	6 and 12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Blood AST level (U/l)	Difference in blood AST level between weeks 6 and 12 weeks compared to baseline	6 and 12 weeks
Secondary	Blood ALT level (U/l)	Difference in blood ALT level between weeks 6 and 12 weeks compared to baseline	6 and 12 weeks
Secondary	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