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High Fat Meal and Postprandial TG Levels With and Without Exercise Intervention

2023年1月27日 更新者:Sibylle Kranz, PhD, RDN、University of Virginia

The Effect of Moderate-Intensity Exercise on Postprandial Plasma Triglyceride Levels Following a High Fat Meal

The objective of this study is to investigate whether "real-life" bouts of MIE are effective at attenuating PPTL after a meal (either a keto-type brownie (KETO) or a high carb (CON) meal of pasta and sauce), compared to non-exercise control. The primary outcome of this study is the measured change in PPTL level from baseline (fasting) to 6 hours postprandial on each activity level. We hypothesize that MIE will decrease PPTL in comparison to rest. For our secondary outcomes, we expect greater decrease in blood pressure, blood glucose, and metabolic rates after the MIE exercise bouts. Finally, we expect that KETO will be rated as more satiating.

調査の概要

詳細な説明

Cardiovascular disease (CVD) is the leading cause of death and disease in the United States with an overall prevalence of about 48% in adults >20 years of age. The Global Burden of Health assessment showed that CVD is largely attributed to dietary risks, followed by high systolic blood pressure (BP), high body mass index (BMI), high total cholesterol and fasting plasma triglycerides (TG), smoking, and inadequate physical activity. Increased plasma TG levels can promote atherosclerosis, atherosclerotic lesions, plaque formation, and heart attack. Consumption of high fat meals (HFM), which are very common in the American diet, likely increase postprandial triglyceride levels (PPTL), in proportion to the fat content of the meal. This is of particular concern because Americans, on average, have ~6 eating occasions throughout the day, thus maintaining a postprandial state of chronically high PPTL.

Additionally, a HFM has also been shown to negatively affect endothelial function, blood pressure, glycemic control, and resting metabolic rate. The decline in endothelial function is thought to be mediated by the oxidative stress caused by the elevated PPTL, which then contributes to proatherogenic state. Glycemic control was also found to be disrupted following consumption of a high fat meal likely due to a change in glucose absorption from the gut, glucose production in the liver, or glucose uptake from skeletal muscle. Conversely, blood pressure does not seem to be significantly affected by a high fat meal when measured up to 4 hours postprandial, although these findings are equivocal.

Recent studies have elucidated a potential role of exercise in attenuating the postprandial lipemia response via several proposed mechanisms including exercise-induced increase in fat oxidation, lipoprotein lipase (LPL) messenger ribonucleic acid (mRNA expression) and LPL activity, reduced hepatic VLDL secretions, and the creation of an energy deficit. LPL is responsible for breaking TGs down into free fatty acids, thus improving TG clearance rates. Exercise has also been shown to attenuate the increase in blood pressure and blood glucose caused by the high fat meal.

Previous studies have found that compared to a non-exercising control, moderate-intensity exercise (MIE) decreases PPTL by about 15.5% (p = 0.03) when performed prior to a HFM likely due to the increase in postprandial fat oxidation rate elicited by the exercise. Following exercise performed post-HFM, PPTL attenuation is believed to be due to a decrease in hepatic very low-density lipoprotein (VLDL) secretion, as studies have shown that hepatic VLDL concentrations decrease about 4.5 hours after exercising under post-absorptive conditions and circulating triglyceride (TG) levels of VLDL decrease by 30%. With the decrease in TG secretion, there is an increase in LPL activity that consequently increases TG clearance. Thus, as time between exercise bout and HFM consumption increases, LPL becomes an ever-increasingly important factor that further improves PPTL clearance. However, many studies have only investigated the effects of exercise prior to HFM consumption. Furthermore, many of these studies rely on exaggerated fat intake or energy expenditure in excess of the Physical Activity Guidelines for Americans. While there is one study that measured effects of exercise following a HFM, only moderate intensity (60% VO2peak) was used, and endothelial function was measured up to 4 hours postprandial the test meal and 2 hours following the exercise. However, the PPTL attenuation depends on the type of exercise, energy expenditure, intensity, energy balance, and timing relative to the HFM. Moderate intensity exercise (MIE), which is categorized as 65-75% of maximal heart rate, leads to an increase in glucose oxidation rates, which can potentially lead to a greater increase in fat oxidation in comparison to rest (no exercise) after a meal. While activity guidelines recommend engaging in either moderate or high intensity exercise, it remains unclear whether MIE changes PPTL differently after an HFM.

The objective of this study is to investigate whether "real-life" bouts of MIE are effective at attenuating PPTL after a meal (either a keto-type brownie (KETO) or a high carb (CON) meal of pasta and sauce), compared to non-exercise control. The primary outcome of this study is the measured change in PPTL level from baseline (fasting) to 6 hours postprandial on each activity level. We hypothesize that MIE will decrease PPTL in comparison to rest. For our secondary outcomes, we expect greater decrease in blood pressure, blood glucose, and metabolic rates after the MIE exercise bouts. Finally, we expect that KETO will be rated as more satiating.

This is a repeated measures cross-over design, in which all subjects will undergo rest (control) and two exercise protocols. The order of the exercise will be randomized using a traditional coin flip where each combination of flips results in a what meal/ exercise type the subject would be participating in that day. We will have an independent individual (not involved in the study) perform the study randomization and maintain the allocation schedule. Due to the nature of the exercise, blinding participants to the exercise intensity is not possible.

研究の種類

介入

入学 (実際)

7

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

    • Virginia
      • Charlottesville、Virginia、アメリカ、22904
        • University of Virginia

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~45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

全て

説明

Inclusion Criteria:

  • Male or female
  • 18-45 years old

Exclusion Criteria:

  • Food allergies (dairy, nuts, food dyes)
  • Orthopedic or musculoskeletal contraindications to exercise
  • Known cardiovascular, pulmonary, or metabolic disease
  • Metal implants that may interfere with bioelectrical impedance analysis
  • Answers "yes" to one or more questions on the Physical Activity Readiness Questionnaire
  • Current smoker
  • Blood pressure of 130/80 or higher
  • Meets or exceeds American College of Sports Medicine guidelines of engaging in 150min/wk of moderate intensity exercise or 75min/wk vigorous intensity exercise Unwilling or unable to follow all aspects of the study protocol
  • Female participants will have to confirm that they have a normal menstrual cycle (10-12 periods per year). If yes, they are only to participate during the follicular phase of the menstrual cycle (i.e., the week following the first day of menses).

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:Diet: high fat meal
Participants will consume either a high fat or a high carbohydrate meal.
participants will consume a high fat (intervention) or high carbohydrate (control) meal.
他の名前:
  • 高脂肪食
実験的:Exercise: medium intensity exercise
After consuming the meal, participants will either exercise at moderate intensity for 30 minutes or rest.
participants will exercise with medium intensity under supervision for 30 minutes (intervention) or rest (control) after consuming the meal.
他の名前:
  • Moderate intensity exercise bout

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
Total Blood triglyceride levels as indicated by fasting triglycerides
時間枠:Baseline
The participant's hand will be turned upward and massaged to increase blood flow. After sanitizing, their index finger will be held in an upward position, and the lancet is placed firmly into the fingertip. The first drop of blood will be discarded. The next drop of blood, from the same fingerstick, will be placed in the device to read triglyceride levels.
Baseline
Total Blood triglyceride levels as indicated by postprandial triglycerides
時間枠:2 hours postprandial
The participant's hand will be turned upward and massaged to increase blood flow. After sanitizing, their index finger will be held in an upward position, and the lancet is placed firmly into the fingertip. The first drop of blood will be discarded. The next drop of blood, from the same fingerstick, will be placed in the device to read triglyceride levels.
2 hours postprandial
Total Blood triglyceride levels as indicated by postprandial triglycerides
時間枠:4 hours postprandial
The participant's hand will be turned upward and massaged to increase blood flow. After sanitizing, their index finger will be held in an upward position, and the lancet is placed firmly into the fingertip. The first drop of blood will be discarded. The next drop of blood, from the same fingerstick, will be placed in the device to read triglyceride levels.
4 hours postprandial
Total Blood triglyceride levels as indicated by postprandial triglycerides
時間枠:5 hours postprandial
The participant's hand will be turned upward and massaged to increase blood flow. After sanitizing, their index finger will be held in an upward position, and the lancet is placed firmly into the fingertip. The first drop of blood will be discarded. The next drop of blood, from the same fingerstick, will be placed in the device to read triglyceride levels.
5 hours postprandial
Total Blood triglyceride levels as indicated by postprandial triglycerides
時間枠:6 hours postprandial
The participant's hand will be turned upward and massaged to increase blood flow. After sanitizing, their index finger will be held in an upward position, and the lancet is placed firmly into the fingertip. The first drop of blood will be discarded. The next drop of blood, from the same fingerstick, will be placed in the device to read triglyceride levels.
6 hours postprandial

二次結果の測定

結果測定
メジャーの説明
時間枠
Blood glucose level as indicated by fasting blood glucose
時間枠:Baseline
Blood glucose will be measured using the device for finger prick blood sampling after arriving in the lab and hourly after consuming the meal.
Baseline
Finger prick blood sample for blood glucose level as indicated by postprandial blood glucose
時間枠:2 hours postprandial
Blood glucose will be measured using the device for finger prick blood sampling after arriving in the lab and hourly after consuming the meal.
2 hours postprandial
Finger prick blood sample for blood glucose level as indicated by postprandial blood glucose
時間枠:4 hours postprandial
Blood glucose will be measured using the device for finger prick blood sampling after arriving in the lab and hourly after consuming the meal.
4 hours postprandial
Finger prick blood sample for blood glucose level as indicated by postprandial blood glucose
時間枠:5 hours postprandial
Blood glucose will be measured using the device for finger prick blood sampling after arriving in the lab and hourly after consuming the meal.
5 hours postprandial
Finger prick blood sample for blood glucose level as indicated by postprandial blood glucose
時間枠:6 hours postprandial
Blood glucose will be measured using the device for finger prick blood sampling after arriving in the lab and hourly after consuming the meal.
6 hours postprandial
Systolic and diastolic Blood pressure
時間枠:Baseline to 6 hours postprandial in 15 minute increments
A Bluetooth blood pressure cuff will also be given to the participant that they will wear continuously throughout the visit; data from the device will be taken at the end of the visit for 15-minute intervals.
Baseline to 6 hours postprandial in 15 minute increments
Indirect Calorimetry: Resting Metabolic Rate
時間枠:Baseline
Participant will lay at rest for 15 minutes prior to starting the test. A metabolic mask will then be placed over their mouth to analyze their oxygen and carbon dioxide usage to estimate their resting metabolic rate and respiratory exchange ratio. This will take about 30 minutes.
Baseline
Indirect Calorimetry: Resting Metabolic Rate
時間枠:2 hour postprandial
Participant will lay at rest for 15 minutes prior to starting the test. A metabolic mask will then be placed over their mouth to analyze their oxygen and carbon dioxide usage to estimate their resting metabolic rate and respiratory exchange ratio. This will take about 30 minutes.
2 hour postprandial
Indirect Calorimetry: Resting Metabolic Rate
時間枠:3 hour postprandial
Participant will lay at rest for 15 minutes prior to starting the test. A metabolic mask will then be placed over their mouth to analyze their oxygen and carbon dioxide usage to estimate their resting metabolic rate and respiratory exchange ratio. This will take about 30 minutes.
3 hour postprandial
Indirect Calorimetry: Resting Metabolic Rate
時間枠:4 hour postprandial
Participant will lay at rest for 15 minutes prior to starting the test. A metabolic mask will then be placed over their mouth to analyze their oxygen and carbon dioxide usage to estimate their resting metabolic rate and respiratory exchange ratio. This will take about 30 minutes.
4 hour postprandial
Indirect Calorimetry: Resting Metabolic Rate
時間枠:5 hour postprandial
Participant will lay at rest for 15 minutes prior to starting the test. A metabolic mask will then be placed over their mouth to analyze their oxygen and carbon dioxide usage to estimate their resting metabolic rate and respiratory exchange ratio. This will take about 30 minutes.
5 hour postprandial
Indirect Calorimetry: Resting Metabolic Rate
時間枠:6 hour postprandial
Participant will lay at rest for 15 minutes prior to starting the test. A metabolic mask will then be placed over their mouth to analyze their oxygen and carbon dioxide usage to estimate their resting metabolic rate and respiratory exchange ratio. This will take about 30 minutes.
6 hour postprandial
Indirect Calorimetry: Respiratory Exchange Ratio
時間枠:Baseline
Participant will lay at rest for 15 minutes prior to starting the test. A metabolic mask will then be placed over their mouth to analyze their oxygen and carbon dioxide usage to estimate their resting metabolic rate and respiratory exchange ratio. This will take about 30 minutes.
Baseline
Indirect Calorimetry: Respiratory Exchange Ratio
時間枠:2 hours postprandial
Participant will lay at rest for 15 minutes prior to starting the test. A metabolic mask will then be placed over their mouth to analyze their oxygen and carbon dioxide usage to estimate their resting metabolic rate and respiratory exchange ratio. This will take about 30 minutes.
2 hours postprandial
Indirect Calorimetry: Respiratory Exchange Ratio
時間枠:3 hours postprandial
Participant will lay at rest for 15 minutes prior to starting the test. A metabolic mask will then be placed over their mouth to analyze their oxygen and carbon dioxide usage to estimate their resting metabolic rate and respiratory exchange ratio. This will take about 30 minutes.
3 hours postprandial
Indirect Calorimetry: Respiratory Exchange Ratio
時間枠:4 hours postprandial
Participant will lay at rest for 15 minutes prior to starting the test. A metabolic mask will then be placed over their mouth to analyze their oxygen and carbon dioxide usage to estimate their resting metabolic rate and respiratory exchange ratio. This will take about 30 minutes.
4 hours postprandial
Indirect Calorimetry: Respiratory Exchange Ratio
時間枠:5 hours postprandial
Participant will lay at rest for 15 minutes prior to starting the test. A metabolic mask will then be placed over their mouth to analyze their oxygen and carbon dioxide usage to estimate their resting metabolic rate and respiratory exchange ratio. This will take about 30 minutes.
5 hours postprandial
Indirect Calorimetry: Respiratory Exchange Ratio
時間枠:6 hours postprandial
Participant will lay at rest for 15 minutes prior to starting the test. A metabolic mask will then be placed over their mouth to analyze their oxygen and carbon dioxide usage to estimate their resting metabolic rate and respiratory exchange ratio. This will take about 30 minutes.
6 hours postprandial

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出版物と役立つリンク

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一般刊行物

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)

2022年3月28日

一次修了 (実際)

2022年11月1日

研究の完了 (実際)

2022年11月1日

試験登録日

最初に提出

2022年3月3日

QC基準を満たした最初の提出物

2022年3月13日

最初の投稿 (実際)

2022年3月23日

学習記録の更新

投稿された最後の更新 (実際)

2023年1月31日

QC基準を満たした最後の更新が送信されました

2023年1月27日

最終確認日

2023年1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

  • HSR210163

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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