Photodegraded Edible Food Dyes

NCT04708704 | Withdrawn

• 1 other identifier: 2000026634
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Assess and contrast the effect of erythrosine and photodegraded erythrosine on thyroid function. Thyroid function will be evaluated as serum triiodothyronine (T3), thyroxine (T4), thyroid stimulating hormone (TSH), T3 resin uptake as well as measures of iodine in serum and plasma before and after a 14-day repeat administration of these edible dyes in drinking water. Dose-related increases in serum and plasma-bound iodine are expected for both erythrosine and photodegraded erythrosine over the 14-day exposure period. TSH is also expected to increase following repeat administration of erythrosine and photodegraded erythrosine. Erythrosine and photodegraded erythrosine are expected to induce an equivalent dose-response increase in thyroid function-related hormone levels.

Conditions

Thyroid; Functional Disturbance

Outcome Measures

Primary Outcomes (2)

• Thyroid Panel

  triiodothyronine (T3), thyroxine (T4), thyroid stimulating hormone (TSH) and T3 resin uptake (T3RU) in serum

  15 days

• Complete blood count (CBC)

  Whole blood

  15 days

Secondary Outcomes (1)

• Iodine

  15 days

Study Arms (1)

Erythrosine, prepared in drinking water

EXPERIMENTAL

One point-of-use technology in development that has demonstrated potential for inactivating viruses in drinking water is the application of an edible photosensitizing dye to the water for disinfection. When exposed to sunlight, the photosensitizing dye produces singlet oxygen, a reactive oxygen species capable of inactivating a wide range of viruses. Erythrosine, an FDA-approved dye, has proven its ability to disinfect drinking water, achieving 4-log inactivation of bacteriophage MS2 in under 10 minutes of sunlight exposure. Furthermore, the dye photobleaches upon exposure to light, and the accompanying distinct color change (e.g., red to transparent) occurs at a rate comparable to the disinfection, providing a safety indication that disinfection has completed, a much-needed function lacking in other point-of-use technologies.

Dietary Supplement: Erythrosine, prepared in drinking water (0.69 mg/kg bw/day); Dietary Supplement: SODIS-treated erythrosine, prepared in drinking water (0.69 mg/kg bw/day); Dietary Supplement: Iodine, prepared in drinking water 0.075 mg/kg bw/day)

Interventions

Erythrosine, prepared in drinking water (0.69 mg/kg bw/day) DIETARY_SUPPLEMENT

Erythrosine will be obtained from Roxy \& Rich Inc. (Intense Water-Soluble Food Colorant - Pink), which is certified to be edible and complies with US FDA, Health Canada, and European food safety standards. The erythrosine will be prepared in 500 mL of drinking water and participants will received single daily doses for 14 days. We will use a targeted dose of 0.69 mg/kg bw.

Erythrosine, prepared in drinking water

SODIS-treated erythrosine, prepared in drinking water (0.69 mg/kg bw/day) DIETARY_SUPPLEMENT

Erythrosine will be SODIS-treated to produce photobleached erythrosine. Transparent 500 mL polyethylene terephthalate (PET) plastic water bottles will be commercially purchased (Kirkland Signature Purified Water). All branding information and labeling will be removed from the bottles. Water bottles will be dosed with \~41 mg erythrosine (0.69 mg/kg bw) using an erythrosine stock solution (8.2 g/L) and will be shaken to mix. The erythrosine-dosed bottles will be placed on a metal shelf and exposed to natural sunlight on the roof of Yale Engineering. Sunlight exposure will be conducted until the absorbance value of erythrosine at the absorption maximum of 526 nm falls below 0.05 above baseline, as measured by ultraviolet-visible spectroscopy. The water bottles containing photobleached erythrosine will be stored under refrigeration in the dark until consumption by participants.

Erythrosine, prepared in drinking water

Iodine, prepared in drinking water 0.075 mg/kg bw/day) DIETARY_SUPPLEMENT

Iodine used in the study will be in the form of FCC-grade potassium iodide, which will be obtained from VWR. FCC grade potassium iodide meets the requirements set by the Food Chemical Codex and is suitable for all applications in foods and beverages. Iodine (control exposure) will be prepared in 500 mL of drinking water and participants will received single daily doses for 14 days. We will use a targeted dose of 0.75 mg/kg bw.

Erythrosine, prepared in drinking water

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be enrolled at Yale University;
• Be 18 years of age or older;
• Be a non-smoker and not be using any contraindicated drugs; and,
• Have no pre-existing health problems.

You may not qualify if:

• Not fluent in English.
• Pregnant
• Diagnosis of a thyroid-related disease.
• Levels of TSH, T3 and T4 outside the normal range.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale University

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Thyroid Diseases

Interventions

Erythrosine; Drinking Water; Iodine

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Fluoresceins; Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Xanthenes; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Polycyclic Compounds; Water; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Halogens; Elements

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The effects of three interventions will be investigated: 1. Erythrosine, prepared in drinking water (0.69 mg/kg bw/day) 2. SODIS-treated erythrosine, prepared in drinking water (0.69 mg/kg bw/day) 3. Iodine, prepared in drinking water 0.075 mg/kg bw/day) The erythrosine and iodine (control exposure) will be prepared in 500 mL of drinking water and participants will received single daily doses for 14 days. This protocol will be repeated for the three subsequent exposure weeks which will be spaced 2 weeks a part. Instead of receiving daily doses of erythrosine, participants will be given 500 mL of water containing photobleached erythrosine or iodine. The spacing between treatment weeks will serve as a washout period.

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: January 14, 2021
• Study Start: September 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: November 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)