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Biomarkers of Meats and Potatoes Intake. (MEPO)

2017年10月9日 更新者:Professor Lars Ove Dragsted、University of Copenhagen

Biomarkers of Meats and Potatoes Intake: a Meal Study in Healthy Men and Women - the MEPO Study.

The discovery of biomarkers for the intake of meats and potatoes is needed for an accurate assessment of the intake of these foods. Twelve healthy subjects were enrolled in a controlled, cross-over meal study, randomized by a Latin square design. The test meals contained 1) beef, pork, chicken and a control meal for the meats and 2) french fries, boiled potatoes, chips and a control for the potato meals. A standardized diet was provided during sample collection. Blood and urine samples were collected up to 48h primarily for untargeted metabolomic profiling. Blood was further collected to study the effect of the meals on insulin and glycemic responses. Effects on satiety were measured by VAS and an ad libitum lunch following the test meals.

調査の概要

詳細な説明

Protein-rich diets improve body weight regulations and are thus believed to play a key role in combating the global obesity epidemic. Protein-rich diets are generally high in meats, some of which have become controverted enough to be considered disease-promoting foods despite their nutritional richness. The degree at which associations with disease differs from causality is however not entirely known.

Assessment of food intake currently relies on food frequency questionnaires (FFQ), 24h recall and dietary records, all of which are self-reporting methods known to be subject to bias and inaccuracy. Biomarkers of food intake emerged thus within the past years to complement the conventional tools as objective measurements of food intake, drawn from biological samples. Several biomarkers of meat consumption have been proposed, however none is currently accepted and used as biomarker(s) of meat intake and none is able to differentiate between the different types of meat.

In the modern diet, meats are very often served with potatoes. To our knowledge, biomarkers of potato intake have not been thoroughly reported in the literature. Different cooking methods were shown to potentially influence the content of bioactive constituents of vegetables, their glycemic index, as well as subsequent energy intake. High heat cooking additionally yields the formation of potentially toxic compounds such as advanced glycation endproducts (AGEs) that were shown to contribute to insulin resistance and type 2 diabetes. In this line, biomarkers of potatoes as such as well as biomarkers to differentiate between different cooking methods would be of great importance in advancing the understanding of nutritional science.

Primary objectives:

  1. To identify acute biomarkers of general meat intake by untargeted metabolomics
  2. To explore the changes in the metabolome as a result of acute exposure to three types of meat and identify meat-specific biomarkers of intake
  3. To identify biomarkers of acute potato intake by untargeted metabolomics
  4. To identify biomarkers that can differentiate between three types of cooking methods
  5. To investigate the effect of the interaction between meat on potatoes on satiety, assessed by registration of intake from an ad libitum meal

Secondary objectives:

  1. To validate already known biomarkers of meat intake by targeted metabolomics
  2. To investigate the effect of the interaction between meat and potatoes on satiety, assessed by visual analogue scales
  3. To investigate the effect of the interaction between meat and potatoes on glucose and insulin responses

研究の種類

介入

入学 (実際)

12

段階

  • 適用できない

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

18年~70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:

  • BMI < 30 kg/m2
  • Eating and tolerating meat, egg, pea, rice, and potatoes
  • No current chronic or infectious disease
  • No medication (oral contraceptive pill and mild antidepressants is allowed)
  • No dietary supplements
  • Did not use antibiotics in the 6 previous months

Exclusion Criteria:

  • Any condition that makes the project responsible researcher to doubt the feasibility of the volunteer's participation
  • Pregnant or lactating women
  • Smoking (12 months of non-smoking is allowed)
  • Vegan or vegetarian
  • Have or have had a drug addiction
  • Blood donations within three months before participating in the current trial or participation in other scientific experiments
  • Alcohol consumption higher than the Danish Health Authority recommendation of 7 or 14 drinks/week for women and men, respectively.

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:基礎科学
  • 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:Meal sequence: 3C1A2B4D

In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.

Each participants randomized to this arm is exposed to 4 test meals in the order 3C1A2B4D.

Participants receive test meals in the sequence 3C1A2B4D
実験的:Meal sequence: 2A3D4C1B

In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.

Each participants randomized to this arm is exposed to 4 test meals in the order 2A3D4C1B.

Participants receive test meals in the sequence 2A3D4C1B
実験的:Meal sequence: 2D4B3A1C

In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.

Each participants randomized to this arm is exposed to 4 test meals in the order 2D4B3A1C.

Participants receive test meals in the sequence 2D4B3A1C
実験的:Meal sequence: 3B2C1D4A

In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.

Each participants randomized to this arm is exposed to 4 test meals in the order 3B2C1D4A.

Participants receive test meals in the sequence 3B2C1D4A
実験的:Meal sequence: 4C2B1A3D

In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.

Each participants randomized to this arm is exposed to 4 test meals in the order 4C2B1A3D.

Participants receive test meals in the sequence 4C2B1A3D
実験的:Meal sequence:1B4D3C2A

In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.

Each participants randomized to this arm is exposed to 4 test meals in the order 1B4D3C2A.

Participants receive test meals in the sequence 1B4D3C2A
実験的:Meal sequence:4A1C2D3B

In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.

Each participants randomized to this arm is exposed to 4 test meals in the order 4A1C2D3B.

Participants receive test meals in the sequence 4A1C2D3B
実験的:Meal sequence:1D3A4B2C

In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.

Each participants randomized to this arm is exposed to 4 test meals in the order 1D3A4B2C.

Participants receive test meals in the sequence 1D3A4B2C
実験的:Meal sequence: 4D3B2C1A

In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.

Each participants randomized to this arm is exposed to 4 test meals in the order 4D3B2C1A.

Participants receive test meals in the sequence 4D3B2C1A
実験的:Meal sequence: 3A4C1B2D

In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.

Each participants randomized to this arm is exposed to 4 test meals in the order 3A4C1B2D.

Participants receive test meals in the sequence 3A4C1B2D
実験的:Meal sequence: 1C2A3D4B

In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.

Each participants randomized to this arm is exposed to 4 test meals in the order 1C2A3D4B.

Participants receive test meals in the sequence 1C2A3D4B
実験的:Meal sequence: 2B1D4A3C

In this study, each participant was randomized to a sequence of the 4 meat meals and to a sequence of the 4 potato meals. The four meat meals consist of a beef meal, a pork meal, a chicken meal or a control meal (1-4). The four potato meals consist of french fries, chips, boiled potatoes or rice (A-D). The test meal consists of one meat meal that was served together with a potato meal. Four different test meals were served in four interventions, separated by a washout period of minimum 12 days. Six hours after the test meal an ad libitum meal was served, consisting of vegetable stew with pasta.

Each participants randomized to this arm is exposed to 4 test meals in the order 2B1D4A3C.

Participants receive test meals in the sequence 2B1D4A3C

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
Urinary meat metabolites (metabolic profiling with mass spectrometry)
時間枠:Hours 0-48
Explorative approach to discover biomarkers of general meat intake and to differentiate between different types of meat
Hours 0-48
Plasma meat metabolites (metabolic profiling with mass spectrometry)
時間枠:Hours 0-48
Explorative approach to discover biomarkers related to general meat intake and/or specific types of meat
Hours 0-48
Urinary potato metabolites (metabolic profiling with mass spectrometry)
時間枠:Hours 0-48
Explorative approach to discover biomarkers of general potato intake and to differentiate between different cooking methods
Hours 0-48
Plasma potato metabolites (metabolic profiling with mass spectrometry)
時間枠:Hours 0-48
Explorative approach to discover biomarkers related to general potato intake and/or related to different cooking methods
Hours 0-48
Objective assessment of satiety
時間枠:Hours 0-7
Measured by the weight of an ad libitum meal
Hours 0-7

二次結果の測定

結果測定
メジャーの説明
時間枠
Urine biomarkers of meat intake
時間枠:Hours 0-48
Targeted approach with mass spectrometry on already proposed meat biomarkers
Hours 0-48
Subjective assessment of satiety
時間枠:Hours 0-6
Assessed by visual analogue scale (VAS)
Hours 0-6
Area under the curve for glucose
時間枠:Minutes 0-180
Glucose is measure at 0, 45, 90, 120, and 180 min after the test meal and the area is determined by the trapezoid method.
Minutes 0-180
Area under the curve for insulin
時間枠:Minutes 0-180
Insulin is measure at 0, 45, 90, 120, and 180 min after the test meal and the area is determined by the trapezoid method.
Minutes 0-180

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。

スポンサー

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)

2015年2月15日

一次修了 (実際)

2015年5月30日

研究の完了 (実際)

2015年5月30日

試験登録日

最初に提出

2017年10月4日

QC基準を満たした最初の提出物

2017年10月9日

最初の投稿 (実際)

2017年10月10日

学習記録の更新

投稿された最後の更新 (実際)

2017年10月10日

QC基準を満たした最後の更新が送信されました

2017年10月9日

最終確認日

2017年10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

  • H-15020401

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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Meal sequence: 3C1A2B4Dの臨床試験

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