跳至主要内容
临床试验/NCT02455388
NCT02455388已完成不适用

d13C Added Sugar Intake Biomarker: Determining Validity in Children

Virginia Polytechnic Institute and State University2 个研究点 分布在 1 个国家目标入组 370 人开始时间: 2014年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
370
试验地点
2
主要终点
delta13C Added Sugar Biomarker

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Cross-sectional study: Age 6-18, both genders
  • Controlled feeding study: Age 12-18, both genders, BMI <95%ile

排除标准

  • Controlled feeding study: Food allergies and/or aversions, BMI>95%ile

研究组 & 干预措施

Low, then high added sugar diet

Experimental

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.

干预措施: High added sugar diet (Dietary Supplement)

Low, then high added sugar diet

Experimental

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.

干预措施: Low added sugar diet (Dietary Supplement)

High, then low added sugar diet

Experimental

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

干预措施: High added sugar diet (Dietary Supplement)

High, then low added sugar diet

Experimental

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

干预措施: Low added sugar diet (Dietary Supplement)

Dietary recall and fingerstick

No Intervention

Participants will complete 4 in-person 24-hr dietary recalls and 2 fingerstick blood samples at Visit 1 and 3 within 3 weeks.

结局指标

主要结局

delta13C Added Sugar Biomarker

时间窗: 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.

次要结局

  • 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.)
  • Diagnostic Value of d13C Biomarker(2-3 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Brenda Davy

Associate Professor

Virginia Polytechnic Institute and State University

研究点 (2)

Loading locations...

相似试验