WithdrawnNot Applicable

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

Stopped: Altered research priorities

Canada0Started 2020-02

Plain-language 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.

Who can participate

Age range35 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Subjects who are unwilling to provide blood and urine samples during the initial and subsequent test points.
✕. Subjects that have consumed Anti-Aging Formula, omega-3 fatty acid (i.e. fish oil, krill oil, algal oil), lutein, zeaxanthin, carotenoids, GLA (borage or evening primrose oils) and/or Vitamin D supplements during the last 3 months
✕. Subjects who were ill (i.e. rhino virus, influenza, etc.) within two weeks prior to the study start, or who have any active systemic infection (infected tooth, bladder infection, sinus infection, etc.)
✕. Subjects taking:
✕. Anti-inflammatory medications including the nonsteroidal anti-inflammatory drugs (NSAID), cyclooxygenase (COX)-1 and COX-2 inhibitors, such as aspirin, ibuprofen (Advil and Voltaren), and naproxen, and acetaminophen (Tylenol®), either routinely or during the 7 days before baseline urine and blood testing.
✕. H2 antagonist/blockers \[e.g. cimetidine (Tagamet®), ranitidine (Zantac®)\]
✕. Anti-histamines \[e.g. fexofenadine (Allegra®), terfenadine (Seldane®), diphenhydramine (Benadryl®), desloratadine (Clarinex®)\], either routinely or during the 7 days before baseline urine and blood testing.
✕. Statins \[e.g. atorvastatin (Lipitor®), lovastatin (Altoprev®), pitavastatin (Livalo®), pravastatin (Pravachol®), rosuvastatin (Crestor®), simvastatin (Zocor®)\]

What they're measuring

Urinary 1-dehydrothromboxane B2 using The Chronic Inflammation Test

Timeframe: Baseline to 90 days

Omega-3 Index

Timeframe: Baseline to 90 days

Urinary 8-hydroxy-2' -deoxyguanosine (8- OHdG)

Timeframe: Baseline to 90 days

Urinary 8-isoprostane

Timeframe: Baseline to 90 days

Trial details

NCT IDNCT03862872

SponsorBend Beauty Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-06

View on ClinicalTrials.gov More Inflammation trials

Plain-language summary

Who can participate

Age range35 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Subjects who are unwilling to provide blood and urine samples during the initial and subsequent test points.
✕. Subjects that have consumed Anti-Aging Formula, omega-3 fatty acid (i.e. fish oil, krill oil, algal oil), lutein, zeaxanthin, carotenoids, GLA (borage or evening primrose oils) and/or Vitamin D supplements during the last 3 months
✕. Subjects who were ill (i.e. rhino virus, influenza, etc.) within two weeks prior to the study start, or who have any active systemic infection (infected tooth, bladder infection, sinus infection, etc.)
✕. Subjects taking:
✕. Anti-inflammatory medications including the nonsteroidal anti-inflammatory drugs (NSAID), cyclooxygenase (COX)-1 and COX-2 inhibitors, such as aspirin, ibuprofen (Advil and Voltaren), and naproxen, and acetaminophen (Tylenol®), either routinely or during the 7 days before baseline urine and blood testing.
✕. H2 antagonist/blockers \[e.g. cimetidine (Tagamet®), ranitidine (Zantac®)\]
✕. Anti-histamines \[e.g. fexofenadine (Allegra®), terfenadine (Seldane®), diphenhydramine (Benadryl®), desloratadine (Clarinex®)\], either routinely or during the 7 days before baseline urine and blood testing.
✕. Statins \[e.g. atorvastatin (Lipitor®), lovastatin (Altoprev®), pitavastatin (Livalo®), pravastatin (Pravachol®), rosuvastatin (Crestor®), simvastatin (Zocor®)\]