---
title: Biological Functions of Carotenoids in Humans
nct_id: NCT00356252
overall_status: COMPLETED
phase: NA
sponsor: Tufts University
study_type: INTERVENTIONAL
primary_condition: Oxidative DNA Damage
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00356252.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00356252"
ct_last_update_post_date: 2008-07-24
last_seen_at: "2026-05-12T06:42:55.313Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Biological Functions of Carotenoids in Humans

**Official Title:** Functional Bioavailability of Carotenoids in Humans

**NCT ID:** [NCT00356252](https://clinicaltrials.gov/study/NCT00356252)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 40
- **Lead Sponsor:** Tufts University
- **Collaborators:** BASF
- **Conditions:** Oxidative DNA Damage
- **Start Date:** 2002-04
- **Completion Date:** 2003-12
- **CT.gov Last Update:** 2008-07-24

## Brief Summary

This study will examine the the efficiency fo absorption of major plant pigments, carotenoids, (lutein, beta-carotene and lycopene)and will measure the biological functions of carotenoids in healthy women in response to an 8-week period of carotenoid supplementation.

The antioxidant capacity (in both the aqueous and lipid compartments), DNA oxidation (single cell gel electrophoresis), Insulin-like Growth Factor (IGF-1), Insulin-like Growth Factor Binding Protein-3 (IGFBP-3), (gene expression profile (high-density filter-based cDNA microarrays), lipid peroxidation (MDA analysis and Isoprostane determination), and antioxidant nutrient levels (carotenoids, tocopherols, ascorbic acid and uric acid) in the circulation will be measured every other week throughout the study period.

## Eligibility

- **Minimum age:** 50 Years
- **Maximum age:** 70 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* normal hematologic parameters, normal serum albumin, normal liver function, normal kidney function, absence of fat malabsorption and no drug intake which would interfere with fat absorption, metabolism or blood clotting.

Exclusion Criteria:

* Subjects with a history of kidney stones, active small bowel disease or resection, atrophic gastritis, hyperlipidemia, insulin-requiring diabetes, alcoholism, pancreatic disease, or bleeding disorders. Exogenous hormone users, smokers. Subjects weighing greater than 20% above or below the NHANES median standard.
```

## Interventions

- **mixed carotenoids** (DRUG)

## Primary Outcomes

- **DNA damage**
- **plasma carotenoid concentrations**

## Secondary Outcomes

- **lipid peroxidation**
- **Total antioxidant capacity**

## Locations (1)

- Jean Mayer USDA-Human Nutrition Research Center on Aging, Tufts University, Boston, Massachusetts, United States

## Recent Field Changes (last 30 days)

- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.jean mayer usda-human nutrition research center on aging, tufts university|boston|massachusetts|united states` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT00356252*  
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