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Influence of Prior Walking on Postprandial Metabolism in Centrally Obese Men

2020年1月27日 更新者:Matthew Roberts、Loughborough University

Influence of Prior Walking on Endothelial Function and Coronary Heart Disease Risk Markers in Centrally Obese South Asian and White European Men

The present study will investigate the effect of prior walking on postprandial metabolism and endothelial function in centrally obese South Asian and White European men.

Participants will complete two, 2-day trials in a random, crossover design separated by at least a week.

On day 1, participants will either rest or complete a 60 minute walk at 60% maximal oxygen uptake. On day 2, participants will arrive at 08:00 having fasted overnight and a baseline venous blood sample and endothelial function measurement will be taken. Participants will consume a high-fat breakfast and lunch and 12 subsequent venous blood samples will be taken throughout the day at standardised intervals to measure a variety of coronary heart disease risk markers. A second endothelial function measurement will be completed 2 hours after the breakfast. Blood pressure will be measured every hour.

It is expected that the South Asian participants will have impaired metabolism and endothelial function compared to their European counterparts but the bout of exercise performed on day 1 will mitigate these responses.

調査の概要

詳細な説明

South Asians have a higher-than-average risk of coronary heart disease. The reasons for this are unclear, but physical inactivity and/or poor responsiveness to exercise may play a role. It is important to understand the effect of exercise on endothelial function and coronary heart disease risk markers in the hope that exercise can be prescribed as an effective treatment to mitigate endothelial dysfunction and the risk of heart disease.

Previous research from the investigators' laboratory has indicated that postprandial metabolism is impaired in South Asian men, but this, and other coronary heart disease risk markers, can be improved with acute exercise. However, the previous research was conducted in apparently healthy South Asian and White European men. The investigators now wish to quantify and compare the coronary heart disease risk marker and endothelial function response to acute exercise in centrally obese South Asian and White European individuals who are at a higher risk for diabetes and cardiovascular disease.

On visit 1, participants will attend the laboratory to undergo preliminary assessments and to be familiarised with the laboratory environment and study procedures. Specifically, health status, habitual physical activity, dietary habits and anthropometric data (height, weight, waist and hip circumference, body fat) will be collected. A HbA1c test will be performed to check participants are not diabetic. The modified Bruce Treadmill test will be performed to predict maximal oxygen uptake.

On visit 2, participants will undergo a magnetic resonance imaging (MRI) scan to quantify regional body composition comprising abdominal subcutaneous adipose tissue, visceral adipose tissue, liver fat percentage, thigh intramuscular adipose tissue and thigh muscle volume.

On visits 3-6 participants will complete two, 2-day trials in a random, crossover design separated by at least 1 week. On day 1 of both trials, participants will arrive fasted at 08:00 and a baseline blood sample, blood pressure and endothelial function measurement will be taken. Participants will consume a standardised high fat breakfast at 09:00 and lunch at 13:00. At 15:30 the participants will walk for 60 minutes at 60% maximal oxygen uptake and complete a second endothelial function measurement at 16:45. Participants will leave the laboratory with a standardised evening meal to consume before 22:00. The control trial will be the same, except no exercise will be performed.

On day 2, participants will arrive at 08:00 having fasted overnight for 10h (except plain water). A cannula will be inserted into the antecubital vein for collection of venous blood samples. Blood pressure will be measured at 08:00 (0h) and again at hourly intervals throughout the day. Endothelial function will measured at 08:15 (0.25h) and again at 3h. At 0h, a fasting blood sample will be collected. Subsequent venous blood samples will be collected at 1.5, 1.75, 2, 3, 4, 5, 5.5, 5.75, 6, 7, 8 and 9h. Participants will consume a standardised high fat breakfast at 1h and a standardised high fat lunch at 5h. The meals consist of 57% fat, 32% carbohydrate and 11% protein. The meals provide 14.3 kcal per kg of body mass.

Participants will rest in the laboratory throughout day 2 of both the exercise and control trials.

研究の種類

介入

入学 (実際)

30

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

      • Loughborough、イギリス、LE11 3TU
        • National Centre for Sport and Exercise Medicine, Loughborough 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~60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

男

説明

Inclusion Criteria:

  • 18 to 60 year old South Asian and White European men;
  • Centrally obese (waist circumference >90cm for South Asians, >94cm for White Europeans);
  • Weight stable for the past 3 months;
  • Non-smokers;
  • No known contradictions to maximal exertion exercise.

Exclusion Criteria:

  • Musculoskeletal injury that has affected normal ambulation within the last month;
  • Congenital heart disease;
  • Any muscle or bone injuries that do not allow them to walk on a treadmill;
  • Uncontrolled exercise-induced asthma;
  • Coagulation or bleeding disorders;
  • Diabetes (metabolism will be different to non-diabetics potentially skewing the data);
  • Taking any medication that might influence fat metabolism;
  • Taking any medication that might influence blood glucose (e.g., insulin for diabetes);
  • Heart conditions;
  • Smoking;
  • Dieting or restrained eating behaviours;
  • Weight fluctuation greater than 3 kg in the previous 3 months to study enrolment;
  • A food allergy.

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:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:Experimental: Exercise
Exercise: Participants will walk for 60 minutes at 60% maximal oxygen uptake on day 1.
最大酸素摂取量の 60% で 60 分間のウォーキング。
介入なし:No Intervention: Control
Participants will rest on day 1.

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
Triacylglycerol changes in response to exercise and feeding
時間枠:Day 1 fasting. Day 2 fasting (0 hour point), 1.5hours, 1.75hours, 2hours, 3hours, 4hours, 5hours, 5.5hours, 5.75hours, 6hours, 7hours, 8hours and 9hours.
Fasting on day 1 and 2. Time-course of plasma triacylglycerol concentrations in response to exercise and/or feeding on day 2.
Day 1 fasting. Day 2 fasting (0 hour point), 1.5hours, 1.75hours, 2hours, 3hours, 4hours, 5hours, 5.5hours, 5.75hours, 6hours, 7hours, 8hours and 9hours.
Endothelial function changes in response to exercise and feeding
時間枠:Day 1 fasting and 8.75hours. Day 2 fasting and 2.5hours.
Changes in endothelial function via flow-mediated dilatation in response to feeding and exercise.
Day 1 fasting and 8.75hours. Day 2 fasting and 2.5hours.

二次結果の測定

結果測定
メジャーの説明
時間枠
総コレステロール
時間枠:断食1日目。断食2日目。
両方の試験の 1 日目と 2 日目の空腹時血漿総コレステロール。
断食1日目。断食2日目。
高比重リポ蛋白コレステロール
時間枠:断食1日目。断食2日目。
両方の試験の 1 日目と 2 日目に高密度リポタンパク質コレステロールを絶食します。
断食1日目。断食2日目。
低比重リポ蛋白コレステロール
時間枠:断食1日目。断食2日目。
両方の試験の 1 日目と 2 日目に低密度リポタンパク質コレステロールを絶食します。
断食1日目。断食2日目。
Glucose changes in response to exercise and/or feeding
時間枠:Day 1 fasting. Day 2 fasting (0 hour point), 1.5hours, 1.75hours, 2hours, 3hours, 4hours, 5hours, 5.5hours, 5.75hours, 6hours, 7hours, 8hours and 9hours.
Fasting on day 1 and 2. Time-course of plasma glucose concentrations in response to exercise and/or feeding on day 2.
Day 1 fasting. Day 2 fasting (0 hour point), 1.5hours, 1.75hours, 2hours, 3hours, 4hours, 5hours, 5.5hours, 5.75hours, 6hours, 7hours, 8hours and 9hours.
Blood pressure changes in response to exercise and/or feeding
時間枠:Day 1 fasting. Day 2 fasting (0 hour point) and 1hours, 2hours, 3hours, 4hours, 5hours, 6hours, 7hours, 8hours and 9hours.
Changes in blood pressure (systolic and diastolic).
Day 1 fasting. Day 2 fasting (0 hour point) and 1hours, 2hours, 3hours, 4hours, 5hours, 6hours, 7hours, 8hours and 9hours.
Insulin changes in response to exercise and/or feeding
時間枠:Day 1 fasting. Day 2 fasting (0 hour point), 1.5hours, 2hours, 4hours, 5hours, 5.5hours, 7hours, 8hours.
Fasting on day 1 and 2. Time-course of plasma insulin concentrations in response to exercise and/or feeding on day 2.
Day 1 fasting. Day 2 fasting (0 hour point), 1.5hours, 2hours, 4hours, 5hours, 5.5hours, 7hours, 8hours.
Non-esterified fatty acids changes in response to exercise and/or feeding
時間枠:Day 1 fasting. Day 2 fasting (0 hour point), 1.5hours, 2hours, 4hours, 5hours, 5.5hours, 7hours and 9hours.
Fasting on day 1 and 2. Time-course of plasma non-esterified fatty acid concentrations in response to exercise and/or feeding on day 2.
Day 1 fasting. Day 2 fasting (0 hour point), 1.5hours, 2hours, 4hours, 5hours, 5.5hours, 7hours and 9hours.
Interleukin-6 changes in response to exercise and/or feeding
時間枠:Day 1 fasting. Day 2 fasting (0 hour point), 3hours, 6hours and 8hours.
Fasting on day 1 and 2. Time-course of plasma interleukin-6 concentrations in response to exercise and/or feeding on day 2.
Day 1 fasting. Day 2 fasting (0 hour point), 3hours, 6hours and 8hours.
C-Reactive protein changes in response to exercise and/or feeding
時間枠:Day 1 fasting. Day 2 fasting (0 hour point), 3hours, 6hours and 8hours.
Fasting on day 1 and 2. Time-course of plasma C-Reactive protein concentrations in response to exercise and/or feeding on day 2.
Day 1 fasting. Day 2 fasting (0 hour point), 3hours, 6hours and 8hours.
Tumor Necrosis Factor concentrations
時間枠:Day 1 fasting. Day 2 fasting.
Fasting tumor necrosis factor on day 1 and 2 of both trials.
Day 1 fasting. Day 2 fasting.
Peroxiredoxin-4 changes in response to exercise and/or feeding
時間枠:Day 1 fasting. Day 2 fasting (0 hour point), 3hours, 6hours and 8hours.
Fasting on day 1 and 2. Time-course of plasma peroxiredoxin-4 concentrations across day 2 of both trials.
Day 1 fasting. Day 2 fasting (0 hour point), 3hours, 6hours and 8hours.
Superoxide dismutase 3
時間枠:Day 1 fasting. Day 2 fasting (0 hour point), 3hours, 6hours and 8hours.
Fasting on day 1 and 2. Time-course of plasma Superoxide dismutase 3 concentrations across day 2 of both trials
Day 1 fasting. Day 2 fasting (0 hour point), 3hours, 6hours and 8hours.

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。

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)

2019年1月3日

一次修了 (実際)

2019年9月1日

研究の完了 (実際)

2019年9月1日

試験登録日

最初に提出

2019年5月13日

QC基準を満たした最初の提出物

2019年5月14日

最初の投稿 (実際)

2019年5月16日

学習記録の更新

投稿された最後の更新 (実際)

2020年1月29日

QC基準を満たした最後の更新が送信されました

2020年1月27日

最終確認日

2020年1月1日

詳しくは

本研究に関する用語

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?

はい

IPD プランの説明

Anonymised individual participant data for all primary and secondary outcome measures will be made available upon request. Study protocol, statistical analysis plan and informed consent forms are also available upon request.

IPD 共有時間枠

The data will become available in 6 months after publication for 1 year.

IPD 共有アクセス基準

Data will be available to other researchers who would like to run the same statistical methods we have used to check the interpretation of results.

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF

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