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d13C Added Sugar Intake Biomarker: Determining Validity in Children

2019年2月5日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (実際)

370

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Virginia
      • Blacksburg、Virginia、アメリカ、24061
        • Virginia Tech

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

6年~18年 (子、大人)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:防止
  • 割り当て:ランダム化
  • 介入モデル:クロスオーバー割り当て
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.
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.
実験的: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.
介入なし: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
delta13C Added Sugar Biomarker
時間枠: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.
2-3 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in d13C: delta13C Added Sugar Biomarker
時間枠: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.
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
時間枠: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.
2-3 weeks

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Brenda M Davy, Ph.D.、Virginia Polytechnic Institute and State University

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2014年4月1日

一次修了 (実際)

2016年7月1日

研究の完了 (実際)

2018年2月1日

試験登録日

最初に提出

2015年5月18日

QC基準を満たした最初の提出物

2015年5月26日

最初の投稿 (見積もり)

2015年5月27日

学習記録の更新

投稿された最後の更新 (実際)

2019年2月26日

QC基準を満たした最後の更新が送信されました

2019年2月5日

最終確認日

2019年2月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • 1R21HD078636-01A1 (米国 NIH グラント/契約)
  • R21HD078636 (米国 NIH グラント/契約)

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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