Expression of Longevity Genes in Response to Extended Fasting (FEELGOOD)
2017年4月18日 更新者：Intermountain Health Care, Inc.
The purpose of this study is to evaluate the effect of fasting on physical changes associated with cardiovascular disease.
調査の概要
詳細な説明
Coronary heart disease (CHD) is the largest contributor to morbidity and mortality in the Western world and is associated with high-calorie diet, high body mass, and a variety of other factors.
CHD can lead to myocardial infarction (MI) and other embolic events.
A growing body of evidence suggests that relatively low caloric intake in the diets of a variety of animals increases longevity and preliminary evidence among humans indicates that such caloric restriction reduces risk factors for CHD, including cholesterol levels, blood pressure, glucose, and obesity.
Caloric restriction has also been shown to alter the expression of certain genes, especially the forkhead box (FOX) O and sirtuin (SIRT) genes whose over-expression has been shown to increase longevity in animal models.
Extended avoidance of caloric intake, also called fasting or short-term starvation, has been shown to increase expression of the FOXA genes that have similar sequence and function as the FOXO genes and that have been shown to increase longevity among animals regardless of FOXO function.
We recently demonstrated that the risk of CHD was significantly lower among patients who reported a history of routine periodic extended fasting.
The two primary hypotheses for this observation are that fasting may improve individual ability to control dietary intake or that fasting may initiate a cascade of protective mechanisms that preserve cellular and metabolic health.
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
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Utah
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Murray、Utah、アメリカ、84107-5701
- Intermountain Medical Center
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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:
- The volunteer (male or non-pregnant female, any ethnicity) must be >18 years of age.
- The volunteer must either have a body mass index of 25.0-35.0 kg/m2 or the combination of a body mass index of 18.5-24.9 kg/m2 and two or more previously or currently measured symptoms of the metabolic syndrome (fasting glucose≥110 mg/dL, triglycerides≥150 mg/dL, high-density lipoprotein cholesterol<40 mg/dL in males or <50 mg/dL in females, systolic blood pressure≥130 mmHg or diastolic blood pressure≥85 mmHg, or waist circumference≥40 inches in males or ≥36 inches in females [glucose and cholesterol levels may be self-reported]).
- The volunteer has not routinely participated in caloric restriction (deliberate limitation of caloric intake of <80% than the FDA-recommended daily caloric intake) within the last 2 years, has not participated in extended fasting (>12 hours at a time) for at least a year, and does not deliberately skip meals as a routine dietary practice.
Exclusion Criteria:
- Body mass index <18.5 or >35 kg/m2.
- Current active cancer treatment, treatment with immunosuppressive medications, or solid organ transplantation within 1 year.
- Presence of immunosuppressive disease, myocardial infarction, peripheral vascular disease, or stroke within the past year.
- Use of insulin.
- Although it is unlikely fasting will harm the pregnant or lactating woman, the dietary restrictions placed on the participant for the duration of the study may conflict with dietary recommendations for pregnant or lactating women. Women of child bearing potential, therefore, will meet an exclusion if they become pregnant.
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：処理
- 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 |
|---|---|
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他の：Fasting Day First
28±4 hours of water-only fasting followed by 28±4 hours fed
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28±4 hours of water-only fasting followed by 28±4 hours fed
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他の：Fed Day First
28± 4 hours fed followed by 28± 4 hours of fasting
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28± 4 hours fed followed by 28± 4 hours of fasting
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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 |
|---|---|---|
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Change From Baseline in Participant Glucose When Fasting and Fed
時間枠：Baseline and 3 days
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Baseline and 3 days
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Change From Baseline in Participant Human Growth Hormone (HGH) When Fasting and Fed
時間枠：Baseline and 3 days
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Baseline and 3 days
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Change From Baseline in Participant Insulin When Fasting and Fed
時間枠：Baseline and 3 days
|
Baseline and 3 days
|
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Change From Baseline in Participant Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) When Fasting and Fed
時間枠：Baseline and 3 days
|
HOMA-IR is used to measure the severity of insulin resistance.
Healthy Range: 1.0 (0.5-1.4) Less than 1.0 is optimal Above 1.9 indicates early insulin resistance Above 2.9 indicates significant insulin resistance
|
Baseline and 3 days
|
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Change From Baseline in Participant Glycogen-Like Protein-1 (GLP-1) When Fasting and Fed
時間枠：Baseline and 3 days
|
Baseline and 3 days
|
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Change From Baseline in Participant Adiponectin When Fasting and Fed
時間枠：Baseline and 3 days
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Baseline and 3 days
|
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Change From Baseline in Participant Fibroblast Growth Factor-21 (FGF-21) When Fasting and Fed
時間枠：Baseline and 3 days
|
Baseline and 3 days
|
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Change From Baseline in Participant White Blood Cell Count (WBC) When Fasting and Fed
時間枠：Baseline and 3 days
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Baseline and 3 days
|
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Change From Baseline in Participant Hemoglobin When Fasting and Fed
時間枠：Baseline and 3 days
|
Baseline and 3 days
|
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Change From Baseline in Participant Red Blood Cell Count (RBC) When Fasting and Fed
時間枠：Baseline and 3 days
|
Baseline and 3 days
|
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Change From Baseline in Participant Hematocrit When Fasting and Fed
時間枠：Baseline and 3 days
|
Baseline and 3 days
|
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Change From Baseline in Participant Platelet Count When Fasting and Fed
時間枠：Baseline and 3 days
|
Baseline and 3 days
|
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Change From Baseline in Participant Mean Corpuscular Volume (MCV) When Fasting and Fed
時間枠：Baseline and 3 days
|
Baseline and 3 days
|
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Change From Baseline in Participant Mean Corpuscular Hemoglobin (MCH) When Fasting and Fed
時間枠：Baseline and 3 days
|
Baseline and 3 days
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Change From Baseline in Participant Mean Corpuscular Hemoglobin Concentration (MCHC) When Fasting and Fed
時間枠：Baseline and 3 days
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Baseline and 3 days
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Change From Baseline in Participant Red Cell Distribution Width (RDW) When Fasting and Fed
時間枠：Baseline and 3 days
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Baseline and 3 days
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Change From Baseline in Participant Mean Platelet Volume (MPV) When Fasting and Fed
時間枠：Baseline and 3 days
|
Baseline and 3 days
|
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Change From Baseline in Participant Bicarbonate When Fasting and Fed
時間枠：Baseline and 3 days
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Baseline and 3 days
|
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Change From Baseline in Participant Sodium When Fasting and Fed
時間枠：Baseline and 3 days
|
Baseline and 3 days
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Change From Baseline in Participant Chloride When Fasting and Fed
時間枠：Baseline and 3 days
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Baseline and 3 days
|
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Change From Baseline in Participant Blood Urea Nitrogen (BUN) When Fasting and Fed
時間枠：Baseline and 3 days
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Baseline and 3 days
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Change From Baseline in Participant Calcium When Fasting and Fed
時間枠：Baseline and 3 days
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Baseline and 3 days
|
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Change From Baseline in Participant Potassium When Fasting and Fed
時間枠：Baseline and 3 days
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Baseline and 3 days
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Change From Baseline in Participant Creatinine When Fasting and Fed
時間枠：Baseline and 3 days
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Baseline and 3 days
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Change From Baseline in Participant Total Cholesterol (TC) When Fasting and Fed
時間枠：Baseline and 3 days
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Baseline and 3 days
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Change From Baseline in Participant Low-Density Lipoprotein Cholesterol (LDL-C) When Fasting and Fed
時間枠：Baseline and 3 days
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Baseline and 3 days
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Change From Baseline in Participant High-Density Lipoprotein Cholesterol (HDL-C) When Fasting and Fed
時間枠：Baseline and 3 days
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Baseline and 3 days
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Change From Baseline in Participant Triglycerides When Fasting and Fed
時間枠：Baseline and 3 days
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Baseline and 3 days
|
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Change From Baseline in Participant TC/HDL Ratio When Fasting and Fed
時間枠：Baseline and 3 days
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Baseline and 3 days
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Change From Baseline in Participant Weight When Fasting and Fed
時間枠：Baseline and 3 days
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Baseline and 3 days
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Change From Baseline in Participant Waist Circumference When Fasting and Fed
時間枠：Baseline and 3 days
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Baseline and 3 days
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Change From Baseline in Participant Systolic Blood Pressure (SBP), Supine When Fasting and Fed
時間枠：Baseline and 3 days
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Baseline and 3 days
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Change From Baseline in Participant Diastolic Blood Pressure (DBP), Supine When Fasting and Fed
時間枠：Baseline and 3 days
|
Baseline and 3 days
|
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Change From Baseline in Participant High Sensitivity C-Reactive Protein (hsCRP) When Fasting and Fed
時間枠：Baseline and 3 days
|
Baseline and 3 days
|
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。
捜査官
- 主任研究者：Benjamin D Horne, PhD、Intermountain Medical Center
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。
一般刊行物
- Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.
- Horne BD, May HT, Anderson JL, Kfoury AG, Bailey BM, McClure BS, Renlund DG, Lappe DL, Carlquist JF, Fisher PW, Pearson RR, Bair TL, Adams TD, Muhlestein JB; Intermountain Heart Collaborative Study. Usefulness of routine periodic fasting to lower risk of coronary artery disease in patients undergoing coronary angiography. Am J Cardiol. 2008 Oct 1;102(7):814-819. doi: 10.1016/j.amjcard.2008.05.021. Epub 2008 Jul 10.
- Horne BD, Muhlestein JB, Lappe DL, May HT, Carlquist JF, Galenko O, Brunisholz KD, Anderson JL. Randomized cross-over trial of short-term water-only fasting: metabolic and cardiovascular consequences. Nutr Metab Cardiovasc Dis. 2013 Nov;23(11):1050-7. doi: 10.1016/j.numecd.2012.09.007. Epub 2012 Dec 7.
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
2010年1月1日
一次修了 (実際)
2010年8月1日
研究の完了 (実際)
2010年10月1日
試験登録日
最初に提出
2010年1月28日
QC基準を満たした最初の提出物
2010年1月29日
最初の投稿 (見積もり)
2010年2月1日
学習記録の更新
投稿された最後の更新 (実際)
2017年7月17日
QC基準を満たした最後の更新が送信されました
2017年4月18日
最終確認日
2011年3月1日
詳しくは
本研究に関する用語
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。