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Effects of Bend Beauty's Anti-Aging Formula on Inflammatory Markers

NCT03862872 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-07-16

No results posted yet for this study

Summary

This is a phase IV, randomized, double-blind, placebo-controlled, three-arm, parallel intervention study including three groups of 25 subjects between 35-65 years of age, treated with either Bend Beauty's Anti-Aging Formula, fish oil control or inert placebo for 90 days, with testing points at baseline, 30, 60, and 90 days.

Conditions

  • Inflammation
  • Skin Abnormalities
  • Skin Pigment
  • Inflammatory Response
  • Skin Inflammation

Interventions

DIETARY_SUPPLEMENT

Anti-Aging Formula

Anti-Aging Formula contains 1050 mg of EPA and 350 mg of DHA from anchovies, sardines, and/or mackerel whole body oil, 120 mg of GLA from Borage (Borago officianalis) seeds, 2.5 mg of zeaxanthin from Capsicum annuum L. fruit, 5 mg of lutein from Tagetes erecta flower, and 25 μg (1000 IU) of vitamin D3 (cholecalciferol) from lanolin per 4 capsule daily dose. This dosage form is the same as is commercially marketed in Canada under license Natural Product Number (NPN) 80077254.

DIETARY_SUPPLEMENT

Control Fish Oil

The control fish oil is a soft gelatin capsule containing 1,106 mg of triglyceride fish oil from anchovies, sardines, and/or mackerel whole body oil. A four capsule per day dose provides 816 mg EPA and 572 mg DHA, which is only slightly less EPA+DHA than is provided within a four capsule per day dose of Anti-Aging Formula. This minor difference would not be expected to alter clinical outcomes.

OTHER

Inert Placebo

The inert placebo is a soft gelatin capsule containing 1040 mg of corn oil.

Sponsors & Collaborators

  • Bend Beauty Inc.

    lead INDUSTRY

Principal Investigators

  • Ben Connolly, ND, BSc. · Cornerstone Naturopathic Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-29
Primary Completion
2021-06-30
Completion
2021-06-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03862872 on ClinicalTrials.gov