NCT03565133

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 21, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

August 17, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2019

Completed
Last Updated

November 18, 2019

Status Verified

November 1, 2019

Enrollment Period

12 months

First QC Date

May 1, 2018

Last Update Submit

November 15, 2019

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Ad libitum food intake

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

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

Secondary Outcomes (3)

  • Satiation/satiety

    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.

  • GI-symptoms

    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.

  • Heart rate variability

    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.

Study Arms (4)

Oral quinine, gastric placebo

EXPERIMENTAL

Oral sham feeding of quinine and a gastric capsule containing placebo (cellulose)

Dietary Supplement: Quinine sham feeding quinineDietary Supplement: Gastric placebo

Oral placebo, gastric quinine

EXPERIMENTAL

Oral sham feeding of placebo (tap water) and a gastric capsule containing quinine

Dietary Supplement: Gastric quinineDietary Supplement: Oral sham feeding placebo

Oral quinine, gastric quinine

EXPERIMENTAL

Oral sham feeding of quinine and a gastric capsule containing quinine

Dietary Supplement: Quinine sham feeding quinineDietary Supplement: Gastric quinine

Oral placebo, gastric placebo

PLACEBO COMPARATOR

Oral sham feeding of placebo (tap water) and a gastric capsule containing placebo (cellulose)

Dietary Supplement: Oral sham feeding placeboDietary Supplement: Gastric placebo

Interventions

Quinine sham feeding quinineDIETARY_SUPPLEMENT

Oral sham feeding with quinine

Oral quinine, gastric placeboOral quinine, gastric quinine
Gastric quinineDIETARY_SUPPLEMENT

A gastric capsule containing quinine

Oral placebo, gastric quinineOral quinine, gastric quinine
Oral sham feeding placeboDIETARY_SUPPLEMENT

Oral sham feeding with placebo (tap water)

Oral placebo, gastric placeboOral placebo, gastric quinine
Gastric placeboDIETARY_SUPPLEMENT

A gastric capsule containing placebo (cellulose)

Oral placebo, gastric placeboOral quinine, gastric placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Venlo, Limburg, 5928 RC, Netherlands

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Participants and investigators will be blinded for the contents of the gastric capsule. Both cannot be blinded for the oral sham feeding
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2018

First Posted

June 21, 2018

Study Start

August 17, 2018

Primary Completion

August 15, 2019

Study Completion

August 15, 2019

Last Updated

November 18, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)