d13C Added Sugar Intake Biomarker: Determining Validity in Children
Condition: Validation Studies
Study type: Interventional

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.
    

Intervention name(s): High added sugar diet; Low added sugar diet
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Study 1: Crossover design Study 2: Cross-sectional design
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Nutrition; Obesity; Pediatric