Treatment Trials

53 Clinical Trials for Various Conditions

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RECRUITING
Sweet Corn and Carotenoids
Description

This study will assess the effect of daily yellow and white sweet corn intake on serum lutein and zeaxanthin concentrations. Skin carotenoid levels using the Veggie Meter will be assessed, and gastrointestinal symptoms and changes in fecal microbiota during a 4-week intervention period will be monitored.

Conditions
COMPLETED
Carotenoids for Collision Athletes
Description

This is a supplement study being conducted to find out if collision sport athletes who are exposed to repetitive head impacts while supplementing with carotenoids will have decreased pro-inflammatory blood biomarkers, increases in macular pigment optical density, improved contrast sensitivity, greater retinal nerve fiber thickness, and better overall visual quality of life scores compared to collision athletes taking a placebo.

COMPLETED
Maternal Carotenoids Across Pregnancy Study
Description

Before infants are born, they depend on their mother to provide the nutrients necessary to grow and develop, such as iron, folic acid, iodine and other vitamins and minerals. Pregnant people also rely on good nutrition to support their own health. In addition to essential nutrients, vitamins, and minerals, there are other natural components found in fruits and vegetables, called phytochemicals, that may support maternal and fetal health during pregnancy. While more is known about the role of phytochemicals in adult health, surprisingly little is known about phytochemical nutrition during pregnancy. This study focuses on a group of phytochemicals, called carotenoids, during pregnancy. The study will determine if and why levels of carotenoids in the body change across the course of pregnancy. Understanding carotenoid nutrition during pregnancy will improve the understanding ofnutrition needs of expectant mothers and their infants. To study these questions, both health pregnant and non-pregnant female adults will report on their dietary intake and participate in body measurements, health surveys, and carotenoid measurements of eyes, skin, and blood at time points corresponding with the first, second, and third trimesters of pregnancy as well as post-partum.

RECRUITING
Enhancing Children's Cognitive Function and Achievement Through Carotenoid Consumption
Description

The aim of this study is to test the casual relationship between carotenoid supplementation, cognitive function, and achievement over a school-year. The central hypothesis is that, relative to the waitlist placebo group, children receiving the carotenoid supplement will exhibit greater gains in cognitive function and achievement.

UNKNOWN
Oral Probiotics on the Shift in Gut Microbiome and Skin Carotenoid Levels
Description

The purpose of this study is to determine how probiotics affects circulating carotenoid levels.

COMPLETED
Evaluation of Changes in Skin Carotenoid Scores in Medical Students Following a Dietary Supplement-based Intervention
Description

Skin Carotenoid Scores (SCS) are a biomarker of overall antioxidant status. This study extends an earlier study in which an increase in skin carotenoid scores (SCS) was observed in subjects who increased their intake of fruits and vegetables. The scores were determined using the Raman Spectroscopy. In that study subjects were assigned to one of four groups based on their baseline SCS. For unknown reasons, the groups with the highest and lowest baseline SCS failed to show an increase whereas the two intermediate groups did. One possible explanation might be that intakes varied more than expected and was not obvious due to self-reporting of intake of fruits and vegetables with different contents.

Conditions
COMPLETED
Evaluation of Changes in Skin Carotenoid Scores in Medical Students Following Dietary Interventions
Description

Skin Carotenoid Scores (SCS) are a biomarker of overall antioxidant status. This study will use Raman Spectroscopy to examine the ability of increased dietary intake of fruits and vegetables to increase SCS in medical students. This will be an observational, non-invasive study examining skin carotenoid levels over time in individuals who have increased their intake by dietary adjustments. Thirty medical students meeting study inclusion criteria will be asked to increase their intake of high antioxidant fruits and vegetables to 4-6 cups per day over an eight week period of time. Students will self-select their fruits and vegetables from a given list and will receive supermarket gift cards to offset the cost of the increased food. Students will be asked to follow their usual diet for one week. Then increase their intake of high antioxidant fruit and vegetable to 4-6 cups per day for eight weeks. Then return to their usual diet for 2 weeks. SCS scores will be taken at baseline and week 1. At the beginning of week 2, students will be asked to increase fruit and vegetable intake to 4-6 cups per day. SCS will be measured every two weeks during the 8-week intervention phase. Students will return to their usual diet for 2 weeks and SCS will be measured at the end of that 2-week period.

Conditions
COMPLETED
Family-based Lifestyle Intervention Program and Carotenoid Supplementation for Children With Obesity
Description

This is a pilot study of children between the ages of 8 to 11 years of age who are obese and participating in an intense family based intervention with a family-focused multi-component lifestyle intervention. In addition, a beta-carotene supplement will be administered to randomized participants.

COMPLETED
Comparison of Carotenoid Bioavailability From Fresh Papaya, Tomato and Carrot
Description

The goal of this study is to determine if papaya fruits are an exceptionally good food source for carotenoids in humans, particularly when compared more common carotenoid sources like carrots and tomatoes. This objective will be accomplished by quantitation of the immediate post-prandial plasma concentrations of parent carotenoids and vitamin A metabolites from subjects who consumed a meal containing fresh papaya, tomato, and carrot.

ACTIVE_NOT_RECRUITING
Carotenoid and Flavonoid Absorption From Red and Tangerine-Type Tomatoes
Description

Eating a diet rich in tomatoes has been associated with decreased risk for a variety of diseases. Tomatoes contain red-colored lycopene (one type of pigment in the class of pigments called carotenoids), which has been associated with the decreased risk of disease in those consuming tomato products; however, tomatoes also contain flavonoids, which may also have health promoting effects. The Tangerine tomato, a unique tomato variety, contains lycopene in a different form that in red tomatoes and this contributes to their characteristic orange color. This "orange lycopene" is more similar to the most common form of lycopene found in the blood and tissue of people who eat a tomato-rich diet, and may be more easily absorbed by the body. The objectives of this study are to determine if carotenoids and flavonoids from Tangerine tomatoes are more easily absorbed by the body than red tomatoes, and to examine if eating Tangerine versus red tomatoes impacts markers of inflammation (response to harmful substances by the body).

COMPLETED
Carotenoid Response to the Intake of Vegetables and Fruits
Description

The purpose of this study is to validate the non-invasive tool, resonance Raman spectroscopy for assessing vegetable and fruit consumption.

COMPLETED
Skin and Serum Carotenoids in Preterm Infants Fed on a Formula Supplemented With Carotenoids
Description

The primary objectives of this study are to compare the serum and skin concentrations of beta-carotene, lutein, and lycopene in preterm infants fed preterm formulas with mixed carotenoids to serum concentrations in preterm infants fed preterm formulas with no added carotenoids and to human milk fed infants. The secondary objective of this study is to evaluate the effects of dietary carotenoids on the developing eye. Stages and zones of retinopathy of prematurity (ROP), retinal function, and retinal characteristics will also be examined.

COMPLETED
Vitamin A Value of Spirulina Carotenoids in Humans
Description

The goal of this protocol is to determine the vitamin A value (equivalence) of spirulina. The investigation will use intrinsically deuterium labeled spirulina and an isotope vitamin A reference dose, 13C10- retinyl acetate (13C10 RAc), in males (n=20). Up to 45 blood samples (10 ml/sample) will be collected from each subject over a two-month period to evaluate the bioavailability and bioconversion of spirulina ß-carotene to vitamin A.

ACTIVE_NOT_RECRUITING
Eye and Carotenoid Augmentation Research and Evaluation (EyeCARE)
Description

The primary study outcomes are to investigate the effects of 4-month daily carotenoid complex supplementation on carotenoid status in the macula and skin and visual fatigue among adults 20-45 years of age. Secondary outcomes will examine the supplementation effects on cognitive function.

COMPLETED
Feasibility of Measuring Skin Carotenoid Level in an Asthma Clinic
Description

The purpose of this study is to assess the use of a practical tool to objectively measure the fruit and vegetable intake in people with asthma.

Conditions
COMPLETED
Plant Pigments for Human Health: Impact of Lycopene and Anthocyanins on Bioefficacy of Provitamin A Carotenoids From Carrots
Description

The proposed research will help characterize the impact that simultaneous consumption of anthocyanins and carotenoids has on the bioavailability of the provitamin A carotenoids a-carotene and b-carotene and the non-provitamin A carotenoid lycopene, and on their respective antidiabetic activity in humans. The central hypothesis is that provitamin A carotenoids will be bioavailable from purple-red multicolored carrots in humans, and the co-ingestion of carotenoids and anthocyanins from these carrots will have synergistic impacts on their respective antioxidant and antidiabetic effects. This hypothesis will be assessed through a 53 day randomized crossover time course study that consists of three arms in which healthy males and females ages 18-40 (n = 12) will consume carrot juice prepared from red, purple-red, or purple carrots. During each arm, participants will switch the type of juice they consume and by the end of the third arm, all participants will have ingested juice made from all three carrot varieties. Blood will be collected at multiple time points over 72 hours following consumption.

Conditions
COMPLETED
"Night Vision and Carotenoids"
Description

Vision at twilight and night is more difficult and dangerous for the entire population, even more so for the elderly and especially for the elderly with degenerative disease. Multiple worldwide laboratories have demonstrated the ability to raise macular pigment optical density with dietary carotenoids. This proposal further evaluates the relationship between macular re- pigmentation and vision under stressed conditions simulating twilight and night driving.

UNKNOWN
Diabetic Retinopathy Functional Evaluation Study: Monitoring Carotenoid Vitamins Treatment Using ERG
Description

To evaluate the differences in retinal function as measured by ERG in diabetics with and without retinopathy 2) the ability of the Chromatic Electroretinogram (chERG) to detect changes in global retinal function following treatment with Carotenoid Vitamins supplement in patients with diabetic retinopathy (DR). 3) the ability of the Full Field flicker (ffERG) to detect changes in global retinal function following treatment with Carotenoid Vitamins supplement in patients with diabetic retinopathy (DR). 4) Changes in retinal function as observed by OCT-Angiography, following treatment with Carotenoid Vitamins supplement in patients with diabetic retinopathy (DR).

UNKNOWN
Prospective Study of Adjunctive Carotenoids Plus Anti-oxidants in Anti-VEGF Treated Diabetic Macular Edema
Description

This study will evaluate the effects of add-on carotenoid plus anti-oxidant nutritional supplementation to standard anti-vascular endothelial growth factor therapy for subjects with center-involved diabetic macular edema

COMPLETED
Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects
Description

This study is designed to test the hypotheses that (1) the third trimester of pregnancy is a period of maternal systemic and ocular carotenoid depletion; (2) prenatal supplementation with 10 milligrams of lutein and 2 milligrams of zeaxanthin will have significant effects on ocular and systemic biomarkers of maternal and infant carotenoid status relative to a matched, standard-of-care prenatal supplement without added lutein and zeaxanthin; and (3) newborn infants with the highest systemic and ocular carotenoid status will have more mature foveal structure. Mothers will be enrolled in the study during their first trimester, and will take the study carotenoid or control supplements for 6 to 8 months. The final study outcome measurements of mothers and infants will be completed within two weeks of the baby's birth.

UNKNOWN
Correlational and Intervention Effects of Egg Consumption on Macular Carotenoids, Cognition, and Achievement During Childhood
Description

The aim of this study is to examine the correlational and intervention effects of egg consumption on macular carotenoids, cognition, and achievement during childhood. Initially, this will be done with correlational examination of egg consumption and macular carotenoids. Individuals with low carotenoid status will be invited to participant in a month-long egg-based dietary intervention aimed at improving carotenoid status.

COMPLETED
The Juice Study: Sensitivity of Skin Carotenoid Status to Detect Change in Intake
Description

This study is designed to see if drinking a tomato-based vegetable juice will increase skin carotenoids.

Conditions
COMPLETED
The Effect of a Nutrient Dense Food on the Skin CarotenoidLevels of School Age Children
Description

Background: In a previous study, children who consumed a high-carotenoid juice over 8 weeks significantly increased skin carotenoid levels as compared to children who consumed a placebo juice. A naturally carotenoid-rich baked product, potentially marketable as a healthy breakfast food alternative, was developed by Utah State University researchers. Objective: To determine the effect and response of a carotenoid-rich baked product on change in skin carotenoid levels among children. Design: A six week randomized controlled trial. Participants/setting: Participants were children age 5-18 during March-June, 2015 living in Cache County, UT (n=46). Intervention: Children were randomly assigned to one of two groups: treatment (n=23) with a high carotenoid baked food or control (n=25) who consumed a baked food with no carotenoids. Children were asked to eat the designated portion of the assigned food once a day for six weeks. Skin carotenoid levels were measured every two weeks by a BioPhotonic scanner and reported in Raman intensity counts. Participants were asked to maintain their diet and completed a food frequency questionnaire at Baseline, Week 3, and Week 6. Uneaten portions of the food were returned to clinic, counted, and recorded. Main outcome measures: Change in skin carotenoid levels as measured in Raman counts over 6 weeks. Statistical analysis performed: Repeated-measures ANOVA was used to assess the group differences in Raman counts.

COMPLETED
Impact of Egg Consumption on Carotenoid and Vitamin D Bioavailability in Pre- and Post-menopausal Women
Description

The 2010 Dietary Guidelines for Americans emphasizes consumption of 4.5 cups of fruits and vegetables daily but the average intake of US adults is only 2.6 cups. This low consumption of fruits and vegetables results in a limited availability of certain nutrients found in these foods such as carotenoids. Dietary carotenoids have health-promoting properties and are known to fight against disease. Although, maintaining adequate vitamin D status is critical for overall skeletal health and the prevention of osteoporosis, vitamin D insufficiency is also widespread in the United States. Eggs, egg yolk in particular, are known to be a good source of lipid and may improve the absorption of carotenoids and vitamin D found in co-consumed vegetables in young and older women. Therefore, the investigators are interested to see if consuming eggs with cooked vegetables will increase carotenoids and vitamin D absorption.

Conditions
UNKNOWN
The Effects of a Carotenoid Intervention on Cognitive Function
Description

Past research suggests that retinal lutein levels are related to cognitive function as measured via behavioral tests. The goal of the present study is to investigate the relationship between lutein and cognitive function in a wider variety of the population (young, healthy adults and older adults), using a wider variety of methods (behavioral testing and neuroimaging).

COMPLETED
Effects of Egg Consumption on Carotenoid Absorption From Co-consumed, Non-Egg Food
Description

The 2010 Dietary Guidelines for Americans emphasizes consumption of 4.5 cups of fruits and vegetables daily but average intake of US adults is only 2.6 cups. This low consumption of fruits and vegetables results in limited availability of certain nutrients found in these foods such as carotenoids. Dietary carotenoids have health beneficial properties and are known to fight against disease. Eggs are known to be a good source of carotenoids and eggs may improve the absorption of carotenoids found in co-consumed fruits and vegetables. Therefore, we are interested to see if consuming eggs with a mixed-vegetable salad will increase carotenoid absorption.

COMPLETED
Novel 13C Carotenoids for Absorption and Metabolism Studies in Humans
Description

Tomatoes contain several compounds which may be beneficial for human health and prevention of disease, although this relationship is poorly understood and very controversial. This study uses a new technology to study the absorption and metabolism of three different compounds found in tomatoes. These compounds are called: phytoene, phytofluene, and lycopene. We hypothesize that by studying the absorption and metabolism of these compounds, we may be able to understand how the compounds may influence health and disease processes.

Conditions
COMPLETED
The Role of Macular Pigment Carotenoids in the Pathogenesis and Treatment of Macular Telangiectasia Type 2 (MacTel)
Description

Macular telangiectasia type 2 ("MacTel Type 2") is an uncommon eye disorder that results in slow vision loss beginning in middle age. The macula is the central part of the retina, which lines the back of the eye like the film of a camera. The macula is responsible for central or reading vision. Telangiectasis refers to dilated, leaky vessels, for example varicose veins in the legs. One of the earliest manifestations of macular telangiectasia type 2 is an acquired reduction and/or redistribution of the macular pigment carotenoids at the foveal center. Currently, the biochemical mechanisms and clinical significance underlying these changes are not known, but it seems likely that better understanding of this phenomenon could lead to new interventions against MacTel. The objectives of this study are to image the maculas of MacTel subjects using two-wavelength autofluorescence imaging and resonance Raman imaging to target the 7-degree radius pigment ring characteristic of macular telangiectasia type 2 in order to gain further insight into the significance of this early clinical sign, and to evaluate whether supplementation with oral zeaxanthin can normalize macular pigment distribution in MacTel subjects

COMPLETED
Dietary Lipids as Primary Modulators of Carotenoid Absorption in Vegetables
Description

The purpose of this research study is to determine how dietary fats and oils influence the absorption of beneficial plant pigments (carotenoids) from vegetables. The study will examine changes in blood carotenoids in response to eating a salad with different fats/oils.

COMPLETED
Correlation Between Skin Carotenoid Levels and Previous History of Skin Cancer
Description

The purpose of this study is to determine the difference of skin carotenoid levels between subjects with previous squamous cell carcinomas (SCC), subjects with previous basal cell carcinomas (BCC) and a control group.