Trial Outcomes & Findings for d13C Added Sugar Intake Biomarker: Determining Validity in Children (NCT NCT02455388)
NCT ID: NCT02455388
Last Updated: 2019-02-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
370 participants
Primary outcome timeframe
2-3 weeks
Results posted on
2019-02-26
Participant Flow
No significant events took place in the study after enrollment but prior to arm assignment.
Participant milestones
| Measure |
Low, Then High Added Sugar Diet
Participants will consume a low added sugar (5% total energy) diet for 7 consecutive days. After a 4-week washout period, participants will consume a high added sugar (25% total energy) diet for 7 consecutive days.
Low and high added sugar diet: Controlled feeding study. Participants will be provided with daily coolers containing foods with low (5%) or high (25%) added sugar to consume for 7 consecutive days. Fasting fingerstick blood samples and weight checks will be performed each morning.
|
High, Then Low Added Sugar Diet
Participants will consume high added sugar (25% total energy) diet for 7 consecutive days. After a 4-week washout period, participants will consume a low added sugar (5% total energy) diet for 7 consecutive days.
High and low added sugar diet: Controlled feeding study. Participants will be provided with daily coolers containing foods with high (25%) or low (5%) added sugar to consume for 7 consecutive days. Fasting fingerstick blood samples and weight checks will be performed each morning.
|
Dietary Recall and Fingerstick
Participants will complete 4 in-person 24-hr dietary recalls and 2 fingerstick blood samples at visits 1 and 3 within 3 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
15
|
337
|
|
Overall Study
COMPLETED
|
17
|
15
|
326
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
11
|
Reasons for withdrawal
| Measure |
Low, Then High Added Sugar Diet
Participants will consume a low added sugar (5% total energy) diet for 7 consecutive days. After a 4-week washout period, participants will consume a high added sugar (25% total energy) diet for 7 consecutive days.
Low and high added sugar diet: Controlled feeding study. Participants will be provided with daily coolers containing foods with low (5%) or high (25%) added sugar to consume for 7 consecutive days. Fasting fingerstick blood samples and weight checks will be performed each morning.
|
High, Then Low Added Sugar Diet
Participants will consume high added sugar (25% total energy) diet for 7 consecutive days. After a 4-week washout period, participants will consume a low added sugar (5% total energy) diet for 7 consecutive days.
High and low added sugar diet: Controlled feeding study. Participants will be provided with daily coolers containing foods with high (25%) or low (5%) added sugar to consume for 7 consecutive days. Fasting fingerstick blood samples and weight checks will be performed each morning.
|
Dietary Recall and Fingerstick
Participants will complete 4 in-person 24-hr dietary recalls and 2 fingerstick blood samples at visits 1 and 3 within 3 weeks.
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
4
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
7
|
Baseline Characteristics
d13C Added Sugar Intake Biomarker: Determining Validity in Children
Baseline characteristics by cohort
| Measure |
Controlled Feeding Study
n=32 Participants
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.
|
Cross-sectional Study
n=326 Participants
Participants will complete 4 in-person 24-hr dietary recalls within 3 weeks and 2 fingerstick blood samples at Visit 1 and 3.
|
Total
n=358 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
32 Participants
n=39 Participants
|
326 Participants
n=41 Participants
|
358 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Continuous
|
15.3 years
STANDARD_DEVIATION 1.6 • n=39 Participants
|
12 years
STANDARD_DEVIATION 3 • n=41 Participants
|
12.6 years
STANDARD_DEVIATION 3.3 • n=35 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=39 Participants
|
167 Participants
n=41 Participants
|
184 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=39 Participants
|
159 Participants
n=41 Participants
|
174 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=39 Participants
|
303 Participants
n=41 Participants
|
334 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
17 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=39 Participants
|
313 Participants
n=41 Participants
|
345 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=39 Participants
|
326 participants
n=41 Participants
|
358 participants
n=35 Participants
|
|
Body Mass Index
|
20.2 kg/m^2
STANDARD_DEVIATION 2.1 • n=39 Participants
|
20.0 kg/m^2
STANDARD_DEVIATION 4.5 • n=41 Participants
|
20.0 kg/m^2
STANDARD_DEVIATION 4.4 • n=35 Participants
|
PRIMARY outcome
Timeframe: 2-3 weeksValidity, 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.
Outcome measures
| Measure |
Cross-sectional Study
n=326 Participants
Participants will complete 4 in-person 24-hr dietary recalls within 3 weeks and 2 fingerstick blood samples at Visit 1 and 3.
|
High Added Sugar Diet
Participants will consume high added sugar (25% total energy) diet for 7 consecutive days.
High and low added sugar diet: Controlled feeding study. Participants will be provided with daily coolers containing foods with high (25%) or low (5%) added sugar to consume for 7 consecutive days. Fasting fingerstick blood samples and weight checks will be performed each morning.
|
|---|---|---|
|
delta13C Added Sugar Biomarker
Visit 1
|
-19.66 ‰ δ13C
Standard Deviation 0.68
|
—
|
|
delta13C Added Sugar Biomarker
Visit 3
|
-19.64 ‰ δ13C
Standard Deviation 0.68
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Cross-sectional Study
n=32 Participants
Participants will complete 4 in-person 24-hr dietary recalls within 3 weeks and 2 fingerstick blood samples at Visit 1 and 3.
|
High Added Sugar Diet
n=32 Participants
Participants will consume high added sugar (25% total energy) diet for 7 consecutive days.
High and low added sugar diet: Controlled feeding study. Participants will be provided with daily coolers containing foods with high (25%) or low (5%) added sugar to consume for 7 consecutive days. Fasting fingerstick blood samples and weight checks will be performed each morning.
|
|---|---|---|
|
Change in d13C: delta13C Added Sugar Biomarker
|
-0.05 ‰
Standard Deviation 0.071
|
0.03 ‰
Standard Deviation 0.083
|
SECONDARY outcome
Timeframe: 2-3 weeksDetermine 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.
Outcome measures
| Measure |
Cross-sectional Study
n=326 Participants
Participants will complete 4 in-person 24-hr dietary recalls within 3 weeks and 2 fingerstick blood samples at Visit 1 and 3.
|
High Added Sugar Diet
Participants will consume high added sugar (25% total energy) diet for 7 consecutive days.
High and low added sugar diet: Controlled feeding study. Participants will be provided with daily coolers containing foods with high (25%) or low (5%) added sugar to consume for 7 consecutive days. Fasting fingerstick blood samples and weight checks will be performed each morning.
|
|---|---|---|
|
Diagnostic Value of d13C Biomarker
|
0.61 Area under the ROC curve
Interval 0.56 to 0.67
|
—
|
Adverse Events
Low, Then High Added Sugar Diet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High, Then Low Added Sugar Diet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cross-sectional Study
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place