The Effect of Fasting on Peak Fat Oxidation, Mitochondrial Coupling and Extracellular Matrix (GlycoFast84)
The Effect of Fasting on Peak Fat Oxidation, Mitochondrial Coupling and Extracellular Matrix in Healthy Men and Lean and Obese Men and Women
調査の概要
詳細な説明
Four groups of young normal weight men (n=10) and women (n=10) and young obese men (n=10) and women (10) are recruited. After verbal and written information is provided signed consent is obtained.
Prior to the first day of the trial, the participants must complete a four-day dietary and exercise record based on the weighing of all food and beverages consumed and tracking all exercise. This is used to asses the participant's habitual diet and activity level. For female participants, an additional form must be completed regarding their menstrual cycle and form of contraception.
On the two trial days (before and after fasting), participants arrive at the laboratory in the morning, and on the first day, the participant will have fasted since the previous evening. Furthermore, participants have been asked to minimize strenous physical activity for 24 hours leading up to testing. Prior to day 1, participants have been instructed to consume a habitual carbohydrate-rich diet for the 48 hours preceding the first test day.
Initially, the participants' body composition is determined by DXA, after which the participants rest for 15 minutes. Subsequently, blood pressure is measured in the supine position whereafter resting energy expenditure is measured by indirect calorimetry. A venous blood sample is taken from the antecubital vein, as well as a biopsy from the m. vastus lateralis and from the subcutaneous abdominal adipose tissue using the Bergström technique applied with suction. After 30 minutes of rest, a graded exercise test on a cycle ergometer is initiated to determine peak fat oxidation and maximal oxygen uptake. After the test is completed and following a minimum of 10 minutes of rest, handgrip strength and knee extension strength are measured. This concludes the test day.
Thereafter, the 84-hour fast is initiated. During the fasting period, the subjects will communicate by telephone each morning with one of the researchers regarding their well-being and any questions they may have. On day 2 subjects will do 1 hour of submaximal exercise. During the fasting subjects will be provided with electrolyte tablets. Following the 84 hours, the subjects return to the laboratory. Here, the same protocol as described above is carried out. This concludes the test day and the experiment.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Jørn W Helge, PhD
- 電話番号:+4528757506
- メール:jhelge@sund.ku.dk
研究場所
-
-
-
Copenhagen、デンマーク、2200
- 募集
- Department of Biomedical Sciences
-
コンタクト:
- Jørn W Helge, PhD
- 電話番号:+4528757506
- メール:jhelge@sund.ku.dk
-
-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Healthy normal weight men aged [18,40] and BMI [18,25]
- Healthy normal weight women [18,40] and BMI [18,25]
- Healthy obese men [18,40] and BMI [30,40]
- Healthy obese women [18,40] and BMI [30,40]
Exclusion Criteria:
- Present or former cardiovascular disease and chronical inflammatory disease
- Consumption of medications and supplements that influence substrate use at rest and/or during exercise
- Pregnancy
研究計画
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:非ランダム化
- 介入モデル:並列代入
- 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:Young normal weight men
BMI [18, 25] Age [18, 40]
|
Long-term fasting (84 hours), physiological testing before and after fasting: sampling of blood, abdominal adipose tissue and skeletal muscle for molecular analysis and respiratory measurements at rest.
|
|
実験的:Young normal weight women
BMI [18, 25] Age [18, 40]
|
Long-term fasting (84 hours), physiological testing before and after fasting: sampling of blood, abdominal adipose tissue and skeletal muscle for molecular analysis and respiratory measurements at rest.
|
|
実験的:Young obese men
BMI [30, 40] Age [18, 40]
|
Long-term fasting (84 hours), physiological testing before and after fasting: sampling of blood, abdominal adipose tissue and skeletal muscle for molecular analysis and respiratory measurements at rest.
|
|
実験的:Young obese women
BMI [30, 40] Age [18, 40]
|
Long-term fasting (84 hours), physiological testing before and after fasting: sampling of blood, abdominal adipose tissue and skeletal muscle for molecular analysis and respiratory measurements at rest.
|
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 |
|---|---|---|
|
The effect of fasting and obesity on protein glycosylation of the extracellular matrix in adipose tissue
時間枠:The fasting will last approximately 84 hours.
|
The composition and protein glycosylation of the extracellular matrix will be measured in abdominal subcutaneous adipose tissue samples in 20 healthy normal weight men and women and 20 healthy obese men and women.
|
The fasting will last approximately 84 hours.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The effect of fasting and obesity on peak fat oxidation
時間枠:The fasting will last approximately 84 hours
|
40 participants (20 healthy normal weight men and women and 20 healthy obese men and women) will fast for 84 hours.
Before and after the fast, peak fat oxidation (mg fat/min) is measured in an incremental bike test using indirect calorimetry.
|
The fasting will last approximately 84 hours
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The effect of fasting and obesity on adipose tissue lipolytic capacity, muscle ketone oxidative capacity and mitochondrial coupling.
時間枠:The fasting will last approximately 84 hours.
|
The lipolytic capacity will be measured in abdominal subcutaneous adipose tissue samples and the capacity for ketone oxidation in vastus lateralis muscle in 20 healthy normal weight men and women and 20 healthy obese men and women.and
In addition mitochondrial respiratory capacity will be measured in the muscle and adipose biopsy samples using high-resolution respirometry (Oxygraphs, Oroboros).
|
The fasting will last approximately 84 hours.
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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
- Molecular Memory of Obesity
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?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- CSR
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
米国FDA規制機器製品の研究
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。