Measuring Single-Serving Grain Intake
2019年7月3日 更新者：Janet Novotny、USDA Beltsville Human Nutrition Research Center
The primary objective of this study is to identify markers of a single meal of whole grain oat and whole grain wheat intake in humans.
調査の概要
詳細な説明
The aim of this study is to identify compounds that are found in blood and urine and are derived from a single meal of whole grain oat or whole grain wheat intake so that epidemiological studies can be conducted to provide more accurate associations between whole grain intake and health.
研究の種類
介入
入学 (実際)
12
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
-
-
Maryland
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Beltsville、Maryland、アメリカ、20705
- USDA-ARS Beltsville Human Nutrition Research Center
-
-
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
21年～75年 (大人、高齢者)
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:
- 21 to 75 years of age
- Voluntarily agree to participate and sign an informed consent form
Exclusion Criteria:
- Body weight less than 110 lbs.
- Have a body mass index below 19 or above 38 kg/m2
- Known (self-reported) allergy or adverse reaction to study foods
- Women who have given birth during the previous 12 months or who are pregnant/lactating or who plan to become pregnant during the study
- History of bariatric surgery or nutrient malabsorption disease (such as celiac disease), Crohn's disease, diabetes, or metabolic disorders that may interfere with the study
- History of certain cancer diagnosis or treatment in the last 3 years
- Smoking or use of tobacco products in the past 6 months
- Suspected or known strictures, fistulas or physiological/mechanical GI obstruction
- Use of certain medications or supplements (prescription or over-the-counter) that may interfere with the study objectives, including blood thinning medications
- Unable or unwilling to give informed consent or communicate with study staff
- Self-report of alcohol or substance abuse within the past 12 months and/or current treatment for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
- Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
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：他の
- 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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：Whole Grain Oat
Volunteers will consume a breakfast meal containing whole grain oats after 7 days of a whole grain free diet.
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A meal containing whole grain oats
|
|
他の：Whole Grain Wheat
Volunteers will consume a breakfast meal containing whole grain wheat after 7 days of a whole grain free diet.
|
A meal containing whole grain wheat
|
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 |
|---|---|---|
|
Identification of unknown biomarkers of grain intake immediately after grain consumption
時間枠：Day 8
|
Blood and Urine metabolomics profiling will be conducted.
Metabolomics refers to the complete set of small molecule metabolites.
The METLIN Metabolomics Database is a repository of such chemicals and contains over 75,000 entries, thus metabolomics is a very broad assessment.
Blood and urine will be broadly analyzed with mass spectrometers for metabolomics, and all ionizing compounds will be captured by the detector, which reports the ratio of mass of the compound to the charge (units: m/z which is mass to charge).
The mass-to-charges will be compared across different time points of collection, and appearance of mass-to-charges in some collections (but not found in others when grains were not consumed) will indicate a biomarker of grain intake.
|
Day 8
|
|
Identification of unknown biomarkers of grain intake a day after grain consumption
時間枠：Day 9
|
Blood and Urine metabolomics profiling will be conducted.
Metabolomics refers to the complete set of small molecule metabolites.
The METLIN Metabolomics Database is a repository of such chemicals and contains over 75,000 entries, thus metabolomics is a very broad assessment.
Blood and urine will be broadly analyzed with mass spectrometers for metabolomics, and all ionizing compounds will be captured by the detector, which reports the ratio of mass of the compound to the charge (units: m/z which is mass to charge).
The mass-to-charges will be compared across different time points of collection, and appearance of mass-to-charges in some collections (but not found in others when grains were not consumed) will indicate a biomarker of grain intake.
|
Day 9
|
|
Identification of unknown biomarkers of grain intake 2 days after grain consumption
時間枠：Day 10
|
Urine metabolomics profiling will be conducted.
Metabolomics refers to the complete set of small molecule metabolites.
The METLIN Metabolomics Database is a repository of such chemicals and contains over 75,000 entries, thus metabolomics is a very broad assessment.
Urine will be broadly analyzed with mass spectrometers for metabolomics, and all ionizing compounds will be captured by the detector, which reports the ratio of mass of the compound to the charge (units: m/z which is mass to charge).
The mass-to-charges will be compared across different time points of collection, and appearance of mass-to-charges in some collections (but not found in others when grains were not consumed) will indicate a biomarker of grain intake.
|
Day 10
|
|
Identification of unknown biomarkers of grain intake immediately after grain consumption
時間枠：Day 34
|
Blood and Urine metabolomics profiling will be conducted.
Metabolomics refers to the complete set of small molecule metabolites.
The METLIN Metabolomics Database is a repository of such chemicals and contains over 75,000 entries, thus metabolomics is a very broad assessment.
Blood and urine will be broadly analyzed with mass spectrometers for metabolomics, and all ionizing compounds will be captured by the detector, which reports the ratio of mass of the compound to the charge (units: m/z which is mass to charge).
The mass-to-charges will be compared across different time points of collection, and appearance of mass-to-charges in some collections (but not found in others when grains were not consumed) will indicate a biomarker of grain intake.
|
Day 34
|
|
Identification of unknown biomarkers of grain intake a day after grain consumption
時間枠：Day 35
|
Blood and Urine metabolomics profiling will be conducted.
Metabolomics refers to the complete set of small molecule metabolites.
The METLIN Metabolomics Database is a repository of such chemicals and contains over 75,000 entries, thus metabolomics is a very broad assessment.
Blood and urine will be broadly analyzed with mass spectrometers for metabolomics, and all ionizing compounds will be captured by the detector, which reports the ratio of mass of the compound to the charge (units: m/z which is mass to charge).
The mass-to-charges will be compared across different time points of collection, and appearance of mass-to-charges in some collections (but not found in others when grains were not consumed) will indicate a biomarker of grain intake.
|
Day 35
|
|
Identification of unknown biomarkers of grain intake 2 days after grain consumption
時間枠：Day 36
|
Urine metabolomics profiling will be conducted.
Metabolomics refers to the complete set of small molecule metabolites.
The METLIN Metabolomics Database is a repository of such chemicals and contains over 75,000 entries, thus metabolomics is a very broad assessment.
Urine will be broadly analyzed with mass spectrometers for metabolomics, and all ionizing compounds will be captured by the detector, which reports the ratio of mass of the compound to the charge (units: m/z which is mass to charge).
The mass-to-charges will be compared across different time points of collection, and appearance of mass-to-charges in some collections (but not found in others when grains were not consumed) will indicate a biomarker of grain intake.
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Day 36
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Blood glucose
時間枠：Days 8 and 34
|
Blood glucose will be measured.
Blood glucose is reported in mmol/L.
|
Days 8 and 34
|
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Serum insulin
時間枠：Days 8 and 34
|
Serum insulin will be measured.
Serum insulin is reported in mIU/L.
|
Days 8 and 34
|
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Serum c-peptide
時間枠：Days 8 and 34
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Serum c-peptide will be measured.
Serum c-peptide is reported in ng/ml.
|
Days 8 and 34
|
|
Non-esterified fatty acids in blood
時間枠：Days 8 and 34
|
Non-esterified fatty acids will be measured in blood.
Non-esterified fatty acids are reported as mEQ/L.
|
Days 8 and 34
|
|
Triglycerides in blood
時間枠：Days 8 and 34
|
Triglycerides will be measured.
Triglycerides are reported as mmol/L.
|
Days 8 and 34
|
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。
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)
2019年5月13日
一次修了 (実際)
2019年6月19日
研究の完了 (実際)
2019年6月19日
試験登録日
最初に提出
2018年12月11日
QC基準を満たした最初の提出物
2018年12月18日
最初の投稿 (実際)
2018年12月21日
学習記録の更新
投稿された最後の更新 (実際)
2019年7月5日
QC基準を満たした最後の更新が送信されました
2019年7月3日
最終確認日
2019年7月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- HS62 - Single Grain
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?
いいえ
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
いいえ
米国FDA規制機器製品の研究
いいえ
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