Carotenoid Response to the Intake of Vegetables and Fruits | NCT01403844

Studies
Carotenoid Response to the Intake of Vegetables and Fruits

NCT01403844

Sponsor

USDA Grand Forks Human Nutrition Research Center

Status

Completed

Last Update Posted

May 20, 2020Actual

Enrollment

29Actual

Phase

Not Applicable

Conditions

Resonance Raman Spectroscopy for Dietary Carotenoid Intake

Interventions

Carotenoid Depletion
Carotenoid Repletion
Carotenoid Depletion
Natural Repletion

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011Actual

Primary Completion Date

Sep 2012Actual

Completion Date

Sep 2012Actual

First Submitted Date

Jul 21, 2011

First Submission Date that Met QC Criteria

Jul 26, 2011

First Posted Date

Jul 27, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 18, 2020

Last Update Posted Date

May 20, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

This study will validate the use of resonance Raman spectroscopy to assess vegetable and fruit intake by performing a controlled feeding study during which volunteers will consume a provided diet with known amounts of carotenoids in the form of fruits and vegetables.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

29Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Skin Carotenoids	Other	Skin carotenoids will be measured under conditions of depletion or repletion	Other: Carotenoid Depletion Other: Carotenoid Repletion Other: Natural Repletion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Carotenoid Depletion	Other	Depletion of carotenoids using a restricted food list	Skin Carotenoids

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serum and skin levels of carotenoids in adults fed a high carotenoid diet		28 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men and women aged 18 - 65 years
Weight stable (±5 lbs) for at least 2 months prior to the start of the study
Body mass index (BMI) between 19-30 kg/m2
Willing to refrain from the use of nicotine and dietary supplements for the duration of the study
Willing to maintain baseline weight and physical activity levels

Exclusion Criteria:

BMI greater than 30.
Gastrointestinal disorders, disease, or medication that affects carotenoid absorption or storage
Current smoker
Allergies or intolerances to foods to be utilized in the study
Consumption of greater than an average of 1 alcoholic drink/day for women and 2/day for men, use of nutritional/sports supplements (if unwilling to discontinue during the study)
Pregnancy or lactating

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
James Roemmich, PhD	USDA Grand Forks Human Nutrition Research Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Grand Forks Human Nutrition Research Center		Grand Forks	North Dakota	58203	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25008856	Derived	Jahns L, Johnson LK, Mayne ST, Cartmel B, Picklo MJ Sr, Ermakov IV, Gellermann W, Whigham LD. Skin and plasma carotenoid response to a provided intervention diet high in vegetables and fruit: uptake and depletion kinetics. Am J Clin Nutr. 2014 Sep;100(3):930-7. doi: 10.3945/ajcn.114.086900. Epub 2014 Jul 9.