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

NCT04933656 | Withdrawn

• 1 other identifier: 16IRG27770080
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Adults

Keywords

Isotopes; Sugar; Diet; Health

Outcome Measures

Primary Outcomes (1)

• Carbon isotope values from blood

  The ratio of carbon 13 to carbon 12 in human blood will be determined.

  30 days

Secondary Outcomes (5)

• Carbon isotope values from hair

  30 days

• Carbon isotope values from fingernails

  30 days

• Nitrogen isotope values from blood

  30 days

• Nitrogen isotope values from hair

  30 days

• Nitrogen isotope values from fingernails

  30 days

Study Arms (4)

50g added sugar

EXPERIMENTAL

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

90g added sugar

EXPERIMENTAL

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

130g added sugar

EXPERIMENTAL

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

170g added sugar

EXPERIMENTAL

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

Interventions

one 24 hr cycle of meals at a 2000 kcal level DIETARY_SUPPLEMENT

50g added sugar

50g added sugar

one 24 hr cycle of meals at a 2000 kcal level + three serving sugar sweetened beverage DIETARY_SUPPLEMENT

170 grams added sugar

170g added sugar

one 24 hr cycle of meals at a 2000 kcal level + one serving sugar sweetened beverage DIETARY_SUPPLEMENT

90 grams added sugar

90g added sugar

one 24 hr cycle of meals at a 2000 kcal level + two servings sugar sweetened beverage DIETARY_SUPPLEMENT

130 grams added sugar

130g added sugar

Eligibility Criteria

• Age: 21 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

San Diego, California, 92093, United States

Location

MeSH Terms

Interventions

Floors and Floorcoverings

Intervention Hierarchy (Ancestors)

Facility Design and Construction; Architecture; Technology, Industry, and Agriculture

Study Officials

• Cheryl A. Anderson, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Double blinding: Participant and person collecting data measurement.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Interim Chair

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

Study Record Dates

• First Submitted: February 21, 2020
• First Posted: June 22, 2021
• Study Start: August 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

US (1)