The Effects of Intragastric Administration of Nutrients on Executive Control in Healthy Subjects.
The previous research by one of our members in the research team (H. Miller) suggests a possible influence of oral nutrients intake of certain fat or carbohydrates (glucose, fructose) on executive control. On the other hand, another previous study from our group (L. Van Oudenhove) suggests a subliminal influence of intragastric administration of fatty acids on subjective and neural responses to negative emotion induction. The purpose of this study therefore is to examine the effect of intragastric administration of certain fatty acids and carbohydrates on executive control in healthy volunteers.
Therefore one group of healthy volunteers are invited to the study. The participants will be randomly administered one of the three fatty acid emulsions or placebo via a nasogastric tube in each of the visits. After the exposure period, participants will use a computer to perform there different tasks to measure executive control. During each study visit, regular measurements of emotion, physical sensations, as well as blood glucose will be assessed. Furthermore, an electrocardiogram will be continuously recorded for the calculation of vagal function.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Leuven、ベルギー、3000
- University Hospitals Leuven, Campus Gasthuisberg
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- N = 26 These numbers are based on a power calculation for a repeated measures ANOVA with one within-subject factor using Gpower software version 3.1.7 (http://www.psycho.uni-duesseldorf.de/abteilungen/aap/gpower3), indicating that these sample sizes are needed to achieve 90% power to detect a medium-sized effect (f = 0.25).
- Men & women
- Age: >17 years
- 20 ≤ BMI ≤ 25
- Of good mental and physical health
Exclusion Criteria:
Participants with one or more of self-reported points below will be excluded:
History of, or current presence of:
- Psychiatric disorders (e.g., anxiety disorders, somatization disorder, eating disorders, depression, substance-related disorders alcohol abuse or dependence etc.)
- Abnormal eating behavior (including restraint and emotional eating)
- Abdominal/thoracic surgery
- Neurological, endocrine or digestive related disorders
- Head trauma with loss of consciousness
- Other serious medical conditions
- Use of any drugs, including cannabis, during the past 6 months
Current presence of:
- Pregnancy
- Medication use that affects the function of the gastrointestinal tract and/or affects the nervous system, psychotropics or painkillers
- A recent accident or surgery that has not fully recovered
Other
- Smoking
- Women not taking hormonal contraception
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：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：Lauric acid
the nutrient that can be widely found in daily food.
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Intragastric infusion of nutrient that can be widely found in daily food or placebo.
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実験的：Palmitic acid
the nutrient that can be widely found in daily food.
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Intragastric infusion of nutrient that can be widely found in daily food or placebo.
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実験的：Capric acid
the nutrient that can be widely found in daily food.
|
Intragastric infusion of nutrient that can be widely found in daily food or placebo.
|
|
プラセボコンパレーター：Saline
physiological salt water
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Intragastric infusion of nutrient that can be widely found in daily food or placebo.
|
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 |
|---|---|---|
|
trial making task
時間枠：60 min after intervention
|
Participants will be required to connect a set of 25 numbered dots in numerical order as fast as possible while still maintaining accuracy.
|
60 min after intervention
|
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digital span task
時間枠：60 min after intervention
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Participants will be presented with a series of single-digit numbers and required to remember them.
After the series has been presented the participants will need to indicate the numbers presented.
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60 min after intervention
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memory task
時間枠：60 min after intervention
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A list of 15 words that are matched for frequency, concreteness, and imagery will be presented to the participant via a computer monitor at the rate of one every 2 sec.
Afterwards they will be given 60 sec to write down as many words as they are able to recall from the list.
Accuracy and errors will be recorded.
|
60 min after intervention
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
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
その他の研究ID番号
- S56123
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。