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COMPLETED NA

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

NCT04761406 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DIETARY_SUPPLEMENT Phaeosol group
  • DIETARY_SUPPLEMENT Placebo group

Study Locations (1)

Texas

  • Exercise & Sport Nutrition Lab — College Station

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2021-04-26
Est. Completion 2023-11-01
Phase NA

Sponsor

Microphyt

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04761406

The ClinicalTrials.gov registry entry for NCT04761406 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Microphyt, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 5 conditions, with Overweight and Obesity appearing as the primary indexed condition, and to 2 interventions — of which Phaeosol group is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04761406 reports 1 study location spanning 1 distinct geographic area — top geographies include Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04761406 about?

NCT04761406 is a clinical study titled "Microalgae Extract Phaeosol Combined to Exercise in Healthy Overweight Women : Efficacy on Body Weight Management". 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) co...

What is the current status of trial NCT04761406?

This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2021-04-26. Estimated completion is 2023-11-01.

What conditions does trial NCT04761406 study?

This clinical trial studies the following conditions: Overweight and Obesity, Exercise, Healthy Lifestyle, Body Weight Changes, Dietary Supplement. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04761406?

The interventions under investigation include: Phaeosol group (DIETARY_SUPPLEMENT), Placebo group (DIETARY_SUPPLEMENT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04761406?

This trial is sponsored by Microphyt, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04761406 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial