Healthy Subjects Clinical Trial
Official title:
Lutein Absorption in Healthy Adults
Verified date | July 2013 |
Source | Abbott Nutrition |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
This study will evaluate the absorption of lutein when consumed in different oil blends.
Status | Completed |
Enrollment | 24 |
Est. completion date | March 2013 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: Subjects will be eligible for the study if they meet all of the following inclusion criteria: - BMI = 18 and = 25 kg/m2 - Between 18 and 45 years of age, inclusive - Male or a non-pregnant, non-lactating female, nulliparous or at least 6 weeks postpartum prior to screening visit. A urine pregnancy test is required for all female subjects unless she is not of childbearing potential. If female is of childbearing potential, is practicing one of the following methods of birth control (and will continue through the duration of the study): - Condoms, sponge, diaphragm or intrauterine device; - Oral or parenteral contraceptives for 3 months prior to screening visit; - Vasectomized partner; - Total abstinence from sexual intercourse. - If on a chronic medication, subject has been on constant dosage for at least two months prior to screening visit Exclusion Criteria: Subjects will be excluded from the study if they meet any of the following criteria: - Current smoker - Current chronic disease, including malabsorption or gastrointestinal disorders; hyperlipidemia; anemia; hemophilia; excessive bleeding; cystic fibrosis; kidney disease requiring dialysis; diabetes; active malignancy; wasting condition - Current chronic contagious, infectious disease, such as active tuberculosis, Hepatitis B or C,or HIV - Vegetarian, or has very selective food habits/dieting - Average intake of alcoholic beverages greater than 2 drinks per day - Medication or dietary supplement use to lower plasma lipids or affect lipid absorption or transport, including antibiotics - Supplement use that contains carotenoids (multi-vitamin as an example) - Known allergy or intolerance to any ingredient found in the study products |
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United States | Biofortis Clinical Research | Addison | Illinois |
Lead Sponsor | Collaborator |
---|---|
Abbott Nutrition |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Plasma lutein | adjusted area under the curve at specified postprandial timepoint | baseline and 336 hours | No |
Secondary | Plasma carotenoids | mean concentrations at specified postprandial timepoints | 2, 4, 6, 8, 12, 24, 48, and 336 hours | No |
Secondary | Plasma lipid concentrations | averaged concentrations at specified postprandial timepoints | baseline and 48 hours | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05483998 -
A Study to Evaluate Single and Multiple Doses of TLC-2716 in Healthy Participants
|
Phase 1 | |
Recruiting |
NCT02235012 -
Cognitive Biases Under Ketamine
|
N/A | |
Recruiting |
NCT02417714 -
Prospective Evaluation of Next Generation CT Reconstruction (NextGenIR)
|
||
Completed |
NCT04418973 -
Analysis of Breath Volatile Organic Compounds After Dyspnea Induced in the Healthy Subject.
|
N/A | |
Completed |
NCT05088343 -
Effect of Hetrombopag on the Pharmacokinetics of Rosuvastatin in Healthy Subjects
|
Phase 1 | |
Not yet recruiting |
NCT06248801 -
Vildagliptin and Metformin Tablets 50/1000 mg Relative to GALVUS MET (50mg/1000 mg) Tablets
|
Phase 1 | |
Terminated |
NCT04068259 -
Single Ascending Dose Study of PBI-4547 in Healthy Subjects
|
Phase 1 | |
Completed |
NCT03279302 -
Trial to Evaluate the PK Profile of Glepaglutide (ZP1848) After a Single IV and After Multiple SC Injections in Healthy Subjects
|
Phase 1 | |
Not yet recruiting |
NCT06233162 -
Febuxostat 80 mg Tablets Relative to Feburic® 80 mg Tablets
|
Phase 1 | |
Recruiting |
NCT04159844 -
Evaluation of the Stiffness and Pressure Applied on the Lower Leg by a New Compression Bandage on Healthy Subjects
|
N/A | |
Completed |
NCT06137911 -
Evaluation of Safety, Tolerability & Pharmacokinetics of JYP0061 in Healthy Adults.
|
Phase 1 | |
Completed |
NCT04849286 -
Measurement of HTL0016878 in Cerebrospinal Fluid
|
Phase 1 | |
Not yet recruiting |
NCT06233227 -
Dutasteride Soft Capsule 0.5 mg Relative to Avodart 0.5 mg Soft Capsule
|
Phase 1 | |
Completed |
NCT04096157 -
A Study to Assess Isavuconazole Following a Single Dose of Isavuconazonium Sulfate Intravenous Solution Via Nasogastric (NG) Tube Compared to a Single Dose of Oral Capsules Under Fasting Conditions in Healthy Participants
|
Phase 1 | |
Completed |
NCT01200368 -
Trial Evaluating a 13-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants
|
Phase 3 | |
Recruiting |
NCT05805033 -
Peri-Implant Soft Tissue Integration in Humans: Influence of Material
|
N/A | |
Completed |
NCT04027803 -
Comparative Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 and Soliris®
|
Phase 1 | |
Recruiting |
NCT03467880 -
Multicenter Study of Impulse Oscillometry in Chinese
|
N/A | |
Completed |
NCT02903095 -
Single Ascending Dose Study of TD-1439 in Healthy Subjects
|
Phase 1 | |
Active, not recruiting |
NCT02341508 -
A Phase 1a, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate Lpathomab in Healthy Volunteers
|
Phase 1 |