Photodegraded Edible Food Dyes

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

Interventions

DIETARY_SUPPLEMENT

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

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.

DIETARY_SUPPLEMENT

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

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.

DIETARY_SUPPLEMENT

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

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.

Sponsors & Collaborators

• Yale University

  lead OTHER

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-09-01

Primary Completion

2023-12-31

Completion

2024-12-31

Countries

• United States

Study Locations