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Effects of a Single Day of Mixed Macronutrient Overfeeding on Energy Balance and Metabolic Responses

2019年1月11日 更新者:Leeds Beckett University

The Effects of a Single Day of Mixed Macronutrient Overfeeding on Energy Balance and Metabolic Responses in Healthy Young Men

Healthy male participants are recruited to observe potentially deleterious changes in appetite regulation and metabolic control. Participants will be provided with an energy intake representative of their daily requirements on the first day of one trial and will be provided with an additional 50% energy intake on the first day of another trial. Outcome variables will be assessed during the second day of each trial in response to a fixed mixed macronutrient meal tolerance test.

調査の概要

詳細な説明

All testing will take place within the Carnegie Research Institute, Leeds Beckett University. We will ask all the participants to visit on five occasions for the completion of a preliminary screening trial and two single-blind counterbalanced experimental trials which each require the participants to visit the laboratory on two consecutive days. The experimental trials will be separated by a minimum of one week.

Visit 1: Preliminary Screening:

Before an individual can take part in the experiment, they will need to undergo screening. Individuals will need to complete a Health Screen Questionnaire. Individuals will be excluded from the study if they are not currently in good health, have any condition that would alter their metabolism and/or have had significant medical problems in the past that may affect the outcomes of the study. Individuals will also be asked to be complete a Three-Factor Eating Questionnaire, to check that they are not restrained eaters, and an International Physical Activity Questionnaire (IPAQ) to ensure that all participants are either sedentary or moderately active. All individuals will be asked to confirm that they have been weight stable for at least six months before participating and that they are not currently dieting. Height, body mass and age will be collected to calculate the energy requirements for the main trials based on the Mifflin equation.

Visits 2, 3, 4 and 5: Experimental Trials:

The participants will be asked to record their food intakes and activity patterns during the three days prior to the first experimental test using a food and physical activity diary. They will then be instructed to repeat this diet and activity pattern prior to the second experimental trial. Participants will be required to arrive at the laboratory for all experimental trials after an overnight fast of at least 10 hours and having refrained from any strenuous activity for 48 hours, and alcohol and caffeine consumption in the previous 24 hours. Two hours before arriving at the laboratory on the day of the experimental trials, participants will be required to ingest 300 mL of water to standardise hydration levels for the trial.

During Day One of each experimental trial, participants will consume a porridge-based breakfast, soup- and pasta-based lunch, and rice-based evening meal under laboratory observation. The meals will contain macronutrient contents representative of current dietary recommendations of 50% carbohydrate, 15% protein and 35% fat. These meals have been selected to facilitate manipulation of the energy content, while matching the meals for appearance and palatability. During one trial, these meals will provide the calculated energy requirement for each individual based on the Mifflin equation and a physical activity factor of 1.4. The meals will be covertly manipulated to provide an additional 50% energy intake during the other trial. The provision of 150% of the estimated energy requirements for participants has been used in previous research for five day periods but will only be provided for a single day in the present study. Participants will be required to consume all of the diet during the standardised phase (i.e. either their daily energy requirements or the 50% overfeed) and will be blinded to the energy content of the trials. After the consumption of the evening meal (~6pm), participants will have fulfilled the requirements for day one and will be asked not to consume any food prior to returning to the laboratory between 7am and 9am the next morning.

On Day Two of each experimental trial day, participants will arrive at the laboratory after an overnight fast and an Introcan Safety Cannula will be placed into a vein in the anticubital space for regular venous blood sampling. Blood samples will be collected in the fasted state and every 30 min after consumption of a standardised breakfast for a period of three hours. After the collection of the final blood sample, the cannula will be removed and participants will be provided with an ad libitum pasta meal (50% carbohydrate, 15% protein, 35% fat) for the assessment of energy intake. Participants will consume ad libitum meals in isolation to prevent any social influences and will be instructed to eat until 'satisfied'.

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

      • Leeds、イギリス、LS6 3QS
        • Leeds Beckett University

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~35年 (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

説明

Inclusion Criteria:

  • weight stable
  • healthy

Exclusion Criteria:

  • any personal history of cardiovascular or metabolic disease
  • smokers
  • currently dieting
  • taking any medication known to influence appetite or metabolic outcomes
  • highly active (IPAQ category 3)

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:Overfeed
Experimental trial where participants are provided with 50% higher energy intake than their estimated requirements on the first day of the trial.
Participants consume energy intakes that are 50% higher than their estimated requirements instead of consuming energy intakes equal to their estimated requirements
実験的:Energy Balance
Experimental trial where participants are provided with an energy intake equal to their estimated requirements on the first day of the trial.
Participants consume energy intakes equal to their estimated requirements instead of consuming intakes that are 50% higher than their estimated requirements

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
Appetite perceptions assessed using 100mm visual analogue scales
時間枠:28 hours
Appetite perceptions using 100mm visual analogue scales
28 hours
Ad libitum energy intake
時間枠:28 hours
Ad libitum energy intake using an ad libitum pasta meal
28 hours
Plasma acylated ghrelin concentrations
時間枠:28 hours
Measured using ELISA from venous blood samples
28 hours
Plasma peptide YY concentrations
時間枠:28 hours
Measured using ELISA from venous blood samples
28 hours
Plasma GLP-1 concentrations
時間枠:28 hours
Measured using ELISA from venous blood samples
28 hours

二次結果の測定

結果測定
メジャーの説明
時間枠
Palatability perceptions assessed using 100mm visual analogue scales
時間枠:28 hours
Palatability of the test meals assessed via 100mm visual analogue scales during the first day of each trial
28 hours
Blinding assessment
時間枠:One week
To assess whether the blinding of dietary manipulation of the first day of each trial was successful. This will be assessed via an exit questionnaire which requires qualitative responses regarding any noticeable differences in the foods provided and what aspect of the food the participants thought had been manipulated during the trials.
One week
Plasma insulin concentrations
時間枠:28 hours
Measured using ELISA from venous blood samples
28 hours
Plasma glucose concentrations
時間枠:28 hours
Measured using photometric analysis from venous blood samples
28 hours
Plasma triglyceride concentrations
時間枠:28 hours
Measured using photometric analysis from venous blood samples
28 hours

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

捜査官

  • 主任研究者:Kevin Deighton, PhD、Leeds Beckett University

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)

2017年5月1日

一次修了 (実際)

2019年1月11日

研究の完了 (実際)

2019年1月11日

試験登録日

最初に提出

2017年8月8日

QC基準を満たした最初の提出物

2017年9月29日

最初の投稿 (実際)

2017年10月4日

学習記録の更新

投稿された最後の更新 (実際)

2019年1月14日

QC基準を満たした最後の更新が送信されました

2019年1月11日

最終確認日

2019年1月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 34693

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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