The Effect of a Nutrient Dense Food on the Skin CarotenoidLevels of School Age Children
The Effect of a Nutrient Dense Food on the Skin Carotenoid Levels of School Age Children
Background: In a previous study, children who consumed a high-carotenoid juice over 8 weeks significantly increased skin carotenoid levels as compared to children who consumed a placebo juice. A naturally carotenoid-rich baked product, potentially marketable as a healthy breakfast food alternative, was developed by Utah State University researchers.
Objective: To determine the effect and response of a carotenoid-rich baked product on change in skin carotenoid levels among children.
Design: A six week randomized controlled trial. Participants/setting: Participants were children age 5-18 during March-June, 2015 living in Cache County, UT (n=46). Intervention: Children were randomly assigned to one of two groups: treatment (n=23) with a high carotenoid baked food or control (n=25) who consumed a baked food with no carotenoids. Children were asked to eat the designated portion of the assigned food once a day for six weeks. Skin carotenoid levels were measured every two weeks by a BioPhotonic scanner and reported in Raman intensity counts. Participants were asked to maintain their diet and completed a food frequency questionnaire at Baseline, Week 3, and Week 6. Uneaten portions of the food were returned to clinic, counted, and recorded.
Main outcome measures: Change in skin carotenoid levels as measured in Raman counts over 6 weeks.
Statistical analysis performed: Repeated-measures ANOVA was used to assess the group differences in Raman counts.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Utah
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Logan、Utah、アメリカ、84322-9815
- Utah State University, Center for Human Nutrition Studies
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Skin carotenoid levels 11,000-33,000 Raman intensity counts
- Age 5-18 years
- Willing to attend 7 clinic visits
- Willing to eat designated food each day for 6 weeks
Exclusion Criteria:
- Illness in two weeks before study began
- Chronic disease such as asthma, rheumatoid arthritis, type 1 diabetes
- Skin carotenoid levels <11,000 and >33,000 Raman intensity counts
- Consumption of high carotenoid supplements
- Use of topical self-tanning lotion
研究計画
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：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ：High-carotenoid food feeding trial
Twenty-three children were randomly assigned to a treatment with a high carotenoid baked food (4.3mg carotenoids/120g, 360 kcal)
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Children were asked to eat the designated portion of the assigned food once a day for six weeks.
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プラセボコンパレーター：No-carotenoid food feeding trial
Twenty-five children were randomly assigned to consume a baked food with no carotenoids (300 kcals/73g)
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Children were asked to eat the designated portion of the assigned food once a day for six weeks.
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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 |
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Raman resonance spectroscopy
時間枠：6 weeks
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The skin carotenoid levels were determined by calculating the average height of the peak Raman absorbance signal obtained and quantified from excitation of skin carotenoids using a low-intensity blue light-emitting diodes light (λ=473 nm) with green light (510 nm) detection.24
The BioPhotonic Scanner Everest 2TM skin carotenoids were reported as Raman intensity counts.
The higher the count, the higher the concentration of carotenoid molecules detected at the site of measurement.
The scanner reports total carotenoid count, rather than individual carotenoid counts, as there is overlap in the absorption spectra of each carotenoid.
During the warm-up process, the black calibration cap, which covers the scanner's light-emitting diodes light, allows the scanner to self-calibrate using a patented process.
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6 weeks
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Karin Allen, PhD、Utah State University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- USU #6351
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。
Feeding trialの臨床試験
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Axonics, Inc.Pacific Clinical Research Group募集