Clinical trial NCT04933656: Use of Stable Carbon And Nitrogen Isotopes to Improve Dietary Assessment for Cardiovascular Disease
Official title: Use of Stable Carbon And Nitrogen Isotopes to Improve Dietary Assessment for Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Adults
Keywords: Isotopes
Sugar
Diet
Health
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2021-06-22
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Dietary intervention consisting of four 24-hour feeding periods (1 feeding period per week for 4 weeks).
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Carbon isotope values from blood
timeFrame: 30 days
Secondary outcomes:
measure: Carbon isotope values from hair
timeFrame: 30 days
measure: Carbon isotope values from fingernails
timeFrame: 30 days
measure: Nitrogen isotope values from blood
timeFrame: 30 days
measure: Nitrogen isotope values from hair
timeFrame: 30 days
measure: Nitrogen isotope values from fingernails
timeFrame: 30 days
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Cheryl A. Anderson, PhD
role: PRINCIPAL_INVESTIGATOR
References: