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Completed

NCT Number: NCT02800538

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.

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Key information

Conditions

Healthy Volunteers

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Leuven, campus Gasthuisberg

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intragastric infusion of nutrient

Dietary Supplement

Intragastric infusion of nutrient that can be widely found in daily food or placebo.

Primary outcomes

  1. trial making task

    Time frame: 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.

  2. digital span task

    Time frame: 60 min after intervention

    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.

  3. memory task

    Time frame: 60 min after intervention

    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.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • KU Leuven

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 15, 2016
Registry last updated
Sep 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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