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

NCT04761406 | Completed

• 1 other identifier: IRB2020-1443
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Fucoxanthin; Weight management; Microalgae; Exercise; Overweight

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (28)

• Total body weight (Kg)

  6 and 12 weeks

• Waist circumference (cm)

  6 and 12 weeks

• Hip circumference (cm)

  6 and 12 weeks

• Resting energy expenditure (Kcal/day)

  6 and 12 weeks

• Maximum oxygen uptake (ml/kg/min)

  6 and 12 weeks

Study Arms (2)

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

Dietary Supplement: Phaeosol group

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

Dietary Supplement: Placebo group

Interventions

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.

Phaeosol group

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.

Placebo group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Microphyt: lead
• Texas A&M University: collaborator

Study Sites (1)

Exercise & Sport Nutrition Lab

College Station, Texas, 77843-4253, United States

Location

Related Publications (2)

• 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.

  PMID: 38613023 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.

  PMID: 33993853 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Body Weight Changes; Motor Activity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Richard B. Kreider

  Exercise & Sport Nutrition Lab - Texas A&M University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, placebo controlled, double-blind, parallel arm intervention trial.

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 18, 2021
• Study Start: April 26, 2021
• Primary Completion: May 1, 2023
• Study Completion: November 1, 2023
• Last Updated: November 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)