Validation Studies
Conditions
Keywords
Nutrition, Obesity, Pediatric
Brief summary
Added sugars (AS) constitute a significant source (\ 16%) of the total daily calories consumed by youth. The role of AS in health is contentious, and the reliance on self-reported dietary data is an often-cited flaw in existing research. The investigators propose to establish the validity of the d13C biomarker for AS intake from fingerstick blood samples in children; our findings could significantly advance research addressing the health impacts of AS intake in children and adolescents.
Detailed description
Consumption of energy-containing added sugars (AS) and in particular, sugar-sweetened beverages (SSB), have been suggested as contributors to weight gain. In children and adolescents, total AS intake represents \ 16% of total energy, or \ 300-400 kcal/d; SSB comprise \ 50% of total AS intake. Although recognized by major health organizations, the role of AS and their primary food source, SSB, in the development and progression of obesity and related co-morbidities remains controversial. A common research limitation in this area is a reliance on self-reported measures of dietary intake, which present additional challenges when studying children. Thus, the need for objective methods to assess dietary intake, such as biomarkers of AS consumption, has been recognized. The investigators have established the validity of the fingerstick blood d13C AS biomarker in adults, and aim to expand our innovative biomarker to studies of diet in children. The investigators propose to establish the validity and reliability of the fingerstick blood d13C AS biomarker in children using two approaches. First, a controlled feeding component (Study 1) will provide data necessary for validation of the biomarker with actual AS intake, and determine its ability to detect levels of AS intake. Second, a cross-sectional component (Study 2) will compare the biomarker to self-reported intake data, collected in a method similar to national nutritional surveillance methodology (i.e., NHANES). Study 1 will include 30 adolescents aged 12-18 yrs, who will consume both a high AS (25% total energy) and low AS (5% total energy) diet for 7 days each, in a random order. Study 2 will include 325 children aged 6-18 yrs, who will complete five laboratory sessions. Record- assisted 24-hr dietary recalls will be completed at four of the sessions to assess habitual AS intake, and fingerstick blood samples will be obtained at two of the sessions. The potential confounding effects of non- sweetener corn and animal product consumption will be addressed in both studies by quantifying non- sweetener corn consumption in the controlled diets (Study 1) and in self-reported dietary recalls (Study 2), and by assessing the nitrogen stable isotope composition d15N of fingerstick samples. To advance existing knowledge of dietary assessment approaches, urinary sugars and urine d13C will be assessed in Study 1, which will permit a direct comparison of biomarkers - existing (urinary sucrose, fructose) and novel (urine and fingerstick d13C ). The role of AS in health has been contentious for decades, and the reliance on self-reported intake data is an often-cited flaw in this area. Our findings could significantly advance research addressing the health impacts of AS intake in children and adolescents.
Interventions
Controlled feeding study. Participants will be provided with daily coolers containing foods with high (25%) added sugar to consume for 7 consecutive days. Fasting fingerstick blood samples and weight checks will be performed each morning.
Controlled feeding study. Participants will be provided with daily coolers containing foods with low (5%) added sugar to consume for 7 consecutive days. Fasting fingerstick blood samples and weight checks will be performed each morning.
Sponsors
Study design
Intervention model description
Study 1: Crossover design Study 2: Cross-sectional design
Eligibility
Inclusion criteria
* Cross-sectional study: Age 6-18, both genders * Controlled feeding study: Age 12-18, both genders, BMI \<95%ile
Exclusion criteria
* Controlled feeding study: Food allergies and/or aversions, BMI\>95%ile
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| delta13C Added Sugar Biomarker | 2-3 weeks | Validity, reliability, and sensitivity of the fingerstick blood d13C AS biomarker during cross-sectional data collection. Participants will provide 4 separate self-reported, record-assisted 24-hr food intake recalls, and at two of the visits, a fingerstick blood sample will be collected to analyze delta13C biomarker levels. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in d13C: delta13C Added Sugar Biomarker | Two 7-day feeding periods, randomized order, with a four-week washout between feeding periods. Outcome is a change in d13C from day 1 to 8, for each feeding period. | Validity, reliability and sensitivity of the fingerstick blood delta13C AS biomarker during feeding study. Participants are provided 7 days of food with high or low added sugar diet. Blood samples will be obtained each day via fingerstick to analyze delta13C biomarker levels. |
| Diagnostic Value of d13C Biomarker | 2-3 weeks | Determine diagnostic value of d13C biomarker using fingerstick blood. The area under the ROC was used as a measure for the diagnostic accuracy of the d13C biomarker, with values closer to 1.0 indicating greater ability to distinguish between low and high added sugar and sugar sweetened beverage consumers. |
Countries
United States
Participant flow
Pre-assignment details
No significant events took place in the study after enrollment but prior to arm assignment.
Participants by arm
| Arm | Count |
|---|---|
| Controlled Feeding Study Participants will be randomly assigned to consume either a high (25% total energy) or low (5% total energy) added sugar diet for the first 7 consecutive day period. After a 4-week washout period, participants will then consume the other diet for another period of 7 consecutive days.
High added sugar diet: Controlled feeding study. Participants will be provided with daily coolers containing foods with high (25%) added sugar to consume for 7 consecutive days. Fasting fingerstick blood samples and weight checks will be performed each morning.
Low added sugar diet: Controlled feeding study. Participants will be provided with daily coolers containing foods with low (5%) added sugar to consume for 7 consecutive days. Fasting fingerstick blood samples and weight checks will be performed each morning. | 32 |
| Cross-sectional Study Participants will complete 4 in-person 24-hr dietary recalls within 3 weeks and 2 fingerstick blood samples at Visit 1 and 3. | 326 |
| Total | 358 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 0 | 4 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 7 |
Baseline characteristics
| Characteristic | Controlled Feeding Study | Cross-sectional Study | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 32 Participants | 326 Participants | 358 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 15.3 years STANDARD_DEVIATION 1.6 | 12 years STANDARD_DEVIATION 3 | 12.6 years STANDARD_DEVIATION 3.3 |
| Body Mass Index | 20.2 kg/m^2 STANDARD_DEVIATION 2.1 | 20.0 kg/m^2 STANDARD_DEVIATION 4.5 | 20.0 kg/m^2 STANDARD_DEVIATION 4.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 6 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants | 303 Participants | 334 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 17 Participants | 18 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 7 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) White | 32 Participants | 313 Participants | 345 Participants |
| Region of Enrollment United States | 32 participants | 326 participants | 358 participants |
| Sex: Female, Male Female | 17 Participants | 167 Participants | 184 Participants |
| Sex: Female, Male Male | 15 Participants | 159 Participants | 174 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 17 | 0 / 337 |
| other Total, other adverse events | 0 / 18 | 0 / 15 | 0 / 337 |
| serious Total, serious adverse events | 0 / 18 | 0 / 15 | 0 / 337 |
Outcome results
delta13C Added Sugar Biomarker
Validity, reliability, and sensitivity of the fingerstick blood d13C AS biomarker during cross-sectional data collection. Participants will provide 4 separate self-reported, record-assisted 24-hr food intake recalls, and at two of the visits, a fingerstick blood sample will be collected to analyze delta13C biomarker levels.
Time frame: 2-3 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cross-sectional Study | delta13C Added Sugar Biomarker | Visit 1 | -19.66 ‰ δ13C | Standard Deviation 0.68 |
| Cross-sectional Study | delta13C Added Sugar Biomarker | Visit 3 | -19.64 ‰ δ13C | Standard Deviation 0.68 |
Change in d13C: delta13C Added Sugar Biomarker
Validity, reliability and sensitivity of the fingerstick blood delta13C AS biomarker during feeding study. Participants are provided 7 days of food with high or low added sugar diet. Blood samples will be obtained each day via fingerstick to analyze delta13C biomarker levels.
Time frame: Two 7-day feeding periods, randomized order, with a four-week washout between feeding periods. Outcome is a change in d13C from day 1 to 8, for each feeding period.
Population: Adolescents aged 12-18 years with a body mass index percentile \<95%. They were willing to follow a controlled diet and did not have food allergies, intolerances or aversions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cross-sectional Study | Change in d13C: delta13C Added Sugar Biomarker | -0.05 ‰ | Standard Deviation 0.071 |
| High Added Sugar Diet | Change in d13C: delta13C Added Sugar Biomarker | 0.03 ‰ | Standard Deviation 0.083 |
Diagnostic Value of d13C Biomarker
Determine diagnostic value of d13C biomarker using fingerstick blood. The area under the ROC was used as a measure for the diagnostic accuracy of the d13C biomarker, with values closer to 1.0 indicating greater ability to distinguish between low and high added sugar and sugar sweetened beverage consumers.
Time frame: 2-3 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cross-sectional Study | Diagnostic Value of d13C Biomarker | 0.61 Area under the ROC curve |