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Completed

NCT Number: NCT03565133

Quinine and Food Intake

Rationale: The appearance of tastants in the small intestine following food ingestion results in the onset of digestion and absorption but can also result in the activation of a negative feedback mechanism from different parts of the intestine to the stomach, the small intestine and to the central nervous system. These processes inhibit food processing, appetite sensations and food intake, and furthermore they increase feelings of satiety and satiation. In this study, we aim to investigate the effects of oral sham feeding and intragastric delivery of a bitter tastant (quinine) on ad libitum food intake, satiation, gastrointestinal symptoms, and heart rate variability.

Objective: To investigate the effect of oral sham feeding and intragastric delivery of a bitter tastant on food intake.

Secondary Objective(s):

1. To compare the effect of oral sham feeding and intragastric delivery of a bitter tastant on satiation. 2. To assess the effect of oral sham feeding and intragastric delivery of a bitter tastant on gastrointestinal symptoms/complaints. 3. To assess the effect of oral sham feeding and intragastric delivery of a bitter tastant on heart rate variability.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University

Venlo, Limburg, 5928 RC, Netherlands

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Based on medical history and previous examination, no gastrointestinal complaints and/or gastrointestinal disorders can be defined.
  • Age ≥18 and ≤65 years. This study will include healthy adult subjects (male and female).
  • BMI ≥18 and ≤25 kg/m2
  • Body weight stable over at least the last 6 months (≤ 5% weight change allowed)

Exclusion criteria

  • History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol. The severity of the disease (major interference with the execution of the experiment or potential influence on the study outcomes) will be decided by the principal investigator.
  • Use of medication that can influence study end-points (to be discussed by medical doctor and principal investigator), including vitamin supplementation, within 14 days prior to testing
  • Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study
  • Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy and hysterectomy allowed, and other surgery upon judgement of medical doctor and principle investigator)
  • Dieting (medically prescribed, vegetarian, diabetic, macrobiological, biological dynamic)
  • Unwillingness to eat lasagna Bolognese meal
  • Pregnancy, lactation
  • Excessive alcohol consumption (>20 alcoholic consumptions per week)
  • Smoking
  • Non-tasters of bitter

Treatment and study plan

Quinine sham feeding quinine

Dietary Supplement

Oral sham feeding with quinine

Gastric quinine

Dietary Supplement

A gastric capsule containing quinine

Oral sham feeding placebo

Dietary Supplement

Oral sham feeding with placebo (tap water)

Gastric placebo

Dietary Supplement

A gastric capsule containing placebo (cellulose)

Primary outcomes

  1. Ad libitum food intake

    Time frame: on each test day at T= 50, 50 minutes after ingestion of the capsule and sham-feeding

    Difference in ad libitum meal intake (as measured during ad libitum pasta meal)

Secondary outcomes

  1. Satiation/satiety

    Time frame: At T= -20 mins, T= -10 mins, T=0 mins, T= 10 mins, T= 20 mins, T= 30 mins, T= 40 mins, T=50 and T= end, where T= 0 is ingestion of capsule and sham-feeding and T= end is whenever the participant finishes the test meal given at T= 50 mins.

    Difference in satiation/satiety (as measured by VAS 0-100mm). VAS scores for satiety feelings (e.g., satiety, fullness, hunger, prospective feeding, desire to eat, desire to snack) will be measured using Visual Analogue Scales (VAS, 0 to 100 mm) anchored at the low end with the most negative or lowest intensity feelings (e.g., extremely unpleasant, not at all), and with opposing terms at the high end (e.g., extremely pleasant, very high, extreme). Volunteers will be asked to indicate on a line which place on the scale best reflects their feeling at that moment. The scoring forms will be collected immediately so that they cannot be used as a reference for later scorings.

  2. GI-symptoms

    Time frame: At T= -20 mins, T= -10 mins, T=0 mins, T= 10 mins, T= 20 mins, T= 30 mins, T= 40 mins, T=50 and T= end, where T= 0 is ingestion of capsule and sham-feeding and T= end is whenever the participant finishes the test meal given at T= 50 mins.

    Difference in gastro-intestinal symptoms (as measured by VAS 0-100mm). VAS scores for gastrointestinal symptoms (burning, bloating, belching, cramps, colics, warm sensation, sensation of abdominal fullness, nausea, pain and relaxation/tensness) will be measured using Visual Analogue Scales (VAS, 0 to 100 mm) anchored at the low end with the most negative or lowest intensity feelings (e.g., extremely unpleasant, not at all), and with opposing terms at the high end (e.g., extremely pleasant, very high, extreme). Volunteers will be asked to indicate on a line which place on the scale best reflects their feeling at that moment. The scoring forms will be collected immediately so that they cannot be used as a reference for later scorings.

  3. Heart rate variability

    Time frame: At T= -150 mins, T= -15 mins, T= 5 mins, and T= 35 mins, where T= -150 is 150 minutes before ingestion of standardized breakfast meal, T= 0 mins is ingestion of capsule and sham-feeding.

    Difference in heartrate variability

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

The Effect of Quinine on Food Intake: Oral Sham Feeding Versus Intragastric Delivery

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 21, 2018
Registry last updated
Nov 18, 2019

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

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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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