I-CAN: Use of Stable Carbon And Nitrogen Isotopes to Improve Dietary Assessment for Cardiovascular Disease

Sponsor

University of California, San Diego (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04933656

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this research study, the investigators will use a novel approach to measure what people eat. The goal is to find out whether stable isotopes that can be measured in blood, hair, and fingernails are better at measuring what people eat than the surveys that are currently used. To meet the goal, the investigators will do three things. First, the investigators will feed study participants known amounts of foods and nutrients. Second, after study participants have eaten the food, the investigators will measure stable isotopes in samples of study participants' blood, hair, and fingernails. Third, the investigators will determine how well these samples reflect what was eaten. The investigators will also give surveys to study participants to determine how well the surveys reflect what was eaten. This will allow the investigators to do a relative comparison of the measurements from isotopes and surveys.

Condition or Disease	Intervention/Treatment	Phase
Healthy Adults	Dietary Supplement: one 24 hr cycle of meals at a 2000 kcal level Dietary Supplement: one 24 hr cycle of meals at a 2000 kcal level + one serving sugar sweetened beverage Dietary Supplement: one 24 hr cycle of meals at a 2000 kcal level + two servings sugar sweetened beverage Dietary Supplement: one 24 hr cycle of meals at a 2000 kcal level + three serving sugar sweetened beverage	N/A

Detailed Description

This is a controlled feeding study in which the relative validity of stable carbon and nitrogen isotope ratio analysis as a biomarker of dietary intake is compared to controlled feedings and multiple 24-hour recalls. Participants will be randomly assigned to a sequence of diets to be fed on four occasions. Participants will undergo 24 hours of controlled feeding on four non-consecutive days over a month-long period. On the day after feeding, participants will complete 24-hour dietary recalls, and provide blood, hair, and fingernail samples for isotope ratio analyses. The investigators will use a crossover design and the diets will be either high or low in C4 plants (i.e., corn and cane products). A 24-hour urine collection will be done at home during each 24-hour feeding period. Participants will have height and weight measured at the screening visit. Weight will also be measured at each study visit. Additionally, data will be collected via questionnaires administered at each study visit.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Dietary intervention consisting of four 24-hour feeding periods (1 feeding period per week for 4 weeks).Dietary intervention consisting of four 24-hour feeding periods (1 feeding period per week for 4 weeks).

Masking:

Double (Participant, Care Provider)

Masking Description:

Double blinding: Participant and person collecting data measurement.

Primary Purpose:

Health Services Research

Official Title:

Use of Stable Carbon And Nitrogen Isotopes to Improve Dietary Assessment for Cardiovascular Disease

Anticipated Study Start Date :

Aug 1, 2021

Anticipated Primary Completion Date :

Feb 1, 2022

Anticipated Study Completion Date :

Feb 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 50g added sugar Crossover design and each participant receives all 4 experimental arms/doses in random order	Dietary Supplement: one 24 hr cycle of meals at a 2000 kcal level 50g added sugar
Experimental: 90g added sugar Crossover design and each participant receives all 4 experimental arms/doses in random order	Dietary Supplement: one 24 hr cycle of meals at a 2000 kcal level + one serving sugar sweetened beverage 90 grams added sugar
Experimental: 130g added sugar Crossover design and each participant receives all 4 experimental arms/doses in random order	Dietary Supplement: one 24 hr cycle of meals at a 2000 kcal level + two servings sugar sweetened beverage 130 grams added sugar
Experimental: 170g added sugar Crossover design and each participant receives all 4 experimental arms/doses in random order	Dietary Supplement: one 24 hr cycle of meals at a 2000 kcal level + three serving sugar sweetened beverage 170 grams added sugar

Outcome Measures

Primary Outcome Measures

Carbon isotope values from blood [30 days]
The ratio of carbon 13 to carbon 12 in human blood will be determined.

Secondary Outcome Measures

Carbon isotope values from hair [30 days]
The ratio of carbon 13 to carbon 12 in human hair samples will be determined.
Carbon isotope values from fingernails [30 days]
The ratio of carbon 13 to carbon 12 in human fingernail samples will be determined.
Nitrogen isotope values from blood [30 days]
The ratio of nitrogen-15 to nitrogen 14 in human blood will be determined.
Nitrogen isotope values from hair [30 days]
The ratio of nitrogen-15 to nitrogen 14 in human hair will be determined.
Nitrogen isotope values from fingernails [30 days]
The ratio of nitrogen-15 to nitrogen 14 in human fingernails will be determined.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 74 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

men and women;
aged 21 and 74 years;
no history of chronic disease and in general good health;
able to provide primary study outcome; and
willing to tolerate study diets designed for controlled feeding.

Exclusion Criteria:

recent dietary changes, restrictions, allergies or preferences;
health conditions that require management beyond the scope of the study (e.g. heart failure, kidney disease, liver disease, gastrointestinal disorder);
history of drug or alcohol abuse;
plans to leave the San Diego area before study completion; and
lack of suitability per investigators' discretion.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Diego	San Diego	California	United States	92093

Sponsors and Collaborators

University of California, San Diego

Investigators

Principal Investigator: Cheryl A. Anderson, PhD, University of California, San Diego

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cheryl A. Anderson, MPH, PhD, Professor, Interim Chair, University of California, San Diego

ClinicalTrials.gov Identifier:

NCT04933656

Other Study ID Numbers:

16IRG27770080

First Posted:

Jun 22, 2021

Last Update Posted:

Jun 22, 2021

Last Verified:

Jun 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Cheryl A. Anderson, MPH, PhD, Professor, Interim Chair, University of California, San Diego

Additional relevant MeSH terms:

Cardiovascular Diseases

Study Results

No Results Posted as of Jun 22, 2021