- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT02455388
d13C Added Sugar Intake Biomarker: Determining Validity in Children
5 lutego 2019 zaktualizowane przez: Brenda Davy, Virginia Polytechnic Institute and State University
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.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
370
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Virginia
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Blacksburg, Virginia, Stany Zjednoczone, 24061
- Virginia Tech
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
6 lat do 18 lat (Dziecko, Dorosły)
Akceptuje zdrowych ochotników
Tak
Płeć kwalifikująca się do nauki
Wszystko
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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 then consume a high added sugar (25% total energy) diet for 7 consecutive days.
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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.
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Eksperymentalny: High, then low added sugar diet
Participants will consume a high added sugar (25% total energy) diet for 7 consecutive days.
After a 4-week washout period, participants will then consume a low added sugar (5% total energy) diet for 7 consecutive days
|
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.
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Brak interwencji: Dietary recall and fingerstick
Participants will complete 4 in-person 24-hr dietary recalls and 2 fingerstick blood samples at Visit 1 and 3 within 3 weeks.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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delta13C Added Sugar Biomarker
Ramy czasowe: 2-3 weeks
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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.
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2-3 weeks
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in d13C: delta13C Added Sugar Biomarker
Ramy czasowe: 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.
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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.
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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.
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Diagnostic Value of d13C Biomarker
Ramy czasowe: 2-3 weeks
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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.
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2-3 weeks
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Współpracownicy
Śledczy
- Główny śledczy: Brenda M Davy, Ph.D., Virginia Polytechnic Institute and State University
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- MacDougall CR, Hill CE, Jahren AH, Savla J, Riebl SK, Hedrick VE, Raynor HA, Dunsmore JC, Frisard MI, Davy BM. The delta13C Value of Fingerstick Blood Is a Valid, Reliable, and Sensitive Biomarker of Sugar-Sweetened Beverage Intake in Children and Adolescents. J Nutr. 2018 Jan 1;148(1):147-152. doi: 10.1093/jn/nxx017.
- Moore LB, Liu SV, Halliday TM, Neilson AP, Hedrick VE, Davy BM. Urinary Excretion of Sodium, Nitrogen, and Sugar Amounts Are Valid Biomarkers of Dietary Sodium, Protein, and High Sugar Intake in Nonobese Adolescents. J Nutr. 2017 Dec;147(12):2364-2373. doi: 10.3945/jn.117.256875. Epub 2017 Sep 20.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
1 kwietnia 2014
Zakończenie podstawowe (Rzeczywisty)
1 lipca 2016
Ukończenie studiów (Rzeczywisty)
1 lutego 2018
Daty rejestracji na studia
Pierwszy przesłany
18 maja 2015
Pierwszy przesłany, który spełnia kryteria kontroli jakości
26 maja 2015
Pierwszy wysłany (Oszacować)
27 maja 2015
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
26 lutego 2019
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
5 lutego 2019
Ostatnia weryfikacja
1 lutego 2019
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- 1R21HD078636-01A1 (Grant/umowa NIH USA)
- R21HD078636 (Grant/umowa NIH USA)
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .