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OpenTrials
Completed

NCT Number: NCT06189001

The Role of Oxytocin-receptor Signalling in Physiological Regulation of Eating Behaviour in Individuals with Obesity

The present study evaluates appetite, glucose metabolism, gastrointestinal motility and energy expenditure in men and women with obesity (BMI 30-40 kg/m2) under oxytocin exposure compared to placebo.

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Key information

Conditions

Adiposity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity 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

Center for Clinical Metabolisk Research

Hellerup, 2100, Denmark

About this study

In a randomised, double-blind, placebo-controlled, crossover fashion, 24 participants will complete two experimental days (A and B) including a mixed meal test and an ad libitum meal test. The procedures during the two experimental days are similar except for intravenous infusion of oxytocin on experimental day A and placebo (saline) on experimental day B, respectively. On experimental days, oxytocin or placebo infusion will be started at timepoint -60 minutes. At timepoint 0 minutes, participants will ingest a liquid mixed meal. After 190 minutes, participants are served an ad libitum meal followed by ad libitum snacks.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age 18-65 years
  • BMI between 30 and 40 kg/m2 (both included)
  • Percentage body fat (BF%) ≥25 for men and ≥32 for women (assessed by bioelectrical impedance analysis)
  • Informed oral and written consent

Exclusion criteria

  • Anaemia (haemoglobin below normal range)
  • Alanine aminotransferase (ALT) >2 times normal values
  • History of hepatobiliary and/or gastrointestinal disorder(s)
  • Kidney disease (serum creatinine above normal range and/or urine albumin-creatinine ratio (uACR) >30 mg/g confirmed by two measures)
  • Previous gastric or intestinal resection, cholecystectomy and/or any major intra-abdominal surgery (including bariatric surgery)
  • Previous pancreatic disease and/or neoplasia
  • Regular tobacco smoking and/or use of other nicotine products
  • Glycated haemoglobin (HbA1c) ≥48 and/or type 1 diabetes or type 2 diabetes requiring medical treatment
  • Pituitary gland disorders
  • Initiation of special diets, lifestyle changes and/or weight loss >5% of total body weight within three months prior to or during study period
  • Pregnancy or breastfeeding
  • Long QTc on electrocardiogram (ECG) at screening (≥0.45 seconds for men and ≥0.46 seconds for women)
  • Any physical or psychological condition or ongoing medication the investigator group suspect would interfere with trial participation

Treatment and study plan

Oxytocin

Drug

Intravenous oxytocin 0.2 IU/min during experimental days

placebo (saline)

Other

Intravenous saline during experimental days

Primary outcomes

  1. Ad libitum food intake

    Time frame: Timepoint 190-220 minutes

    Amount consumed (kcal)

Secondary outcomes

  1. Ad libitum food intake

    Time frame: Timepoint 190-220 minutes

    Amount consumed (kcal/kg)

  2. Sensations of hunger

    Time frame: Timepoint -100 to 160 minutes

    Visual analogue score (VAS) (0-100 mm) (bsAUC)

  3. Sensations of satiety

    Time frame: Timepoint -100 to 160 minutes

    Visual analogue score (VAS) (0-100 mm) (bsAUC)

  4. Sensations of fullness

    Time frame: Timepoint -100 to 160 minutes

    Visual analogue score (VAS) (0-100 mm) (bsAUC)

  5. Sensations of prospective food intake

    Time frame: Timepoint -100 to 160 minutes

    Visual analogue score (VAS) (0-100 mm) (bsAUC)

  6. Sensations of nausea

    Time frame: Timepoint -100 to 160 minutes

    Visual analogue score (VAS) (0-100 mm) (bsAUC)

  7. Sensations of thirst

    Time frame: Timepoint -100 to 160 minutes

    Visual analogue score (VAS) (0-100 mm) (bsAUC)

  8. Sensations of comfort

    Time frame: Timepoint -100 to 160 minutes

    Visual analogue score (VAS) (0-100 mm) (bsAUC)

  9. Composite appetite score

    Time frame: Timepoint -100 to 160

    Calculated from VAS of hunger, fullness and prospective food intake (bsAUC)

  10. Plasma concentrations of glucose

    Time frame: Timepoint -95 to 180 minutes

    Baseline

  11. Plasma concentrations of glucose

    Time frame: Timepoint -95 to 180 minutes

    bsAUC

  12. Plasma concentrations of glucose

    Time frame: Timepoint -95 to 180 minutes

    Peak value

  13. Serum concentrations of insulin

    Time frame: Timepoint -95 to 180 minutes

    Baseline

  14. Serum concentrations of insulin

    Time frame: Timepoint -95 to 180 minutes

    bsAUC

  15. Serum concentrations of C-peptide

    Time frame: Timepoint -95 to 180 minutes

    Baseline

  16. Serum concentrations of C-peptide

    Time frame: Timepoint -95 to 180 minutes

    bsAUC

  17. Beta cell function (C-peptide/glucose-ratio)

    Time frame: Timepoint -95 to 180 minutes

    Baseline

  18. Beta cell function (C-peptide/glucose-ratio)

    Time frame: Timepoint -95 to 180 minutes

    bsAUC

  19. Plasma concentrations of cholecystokinin

    Time frame: Timepoint -95 to 180 minutes

    Baseline

  20. Plasma concentrations of cholecystokinin

    Time frame: Timepoint -95 to 180 minutes

    bsAUC

  21. Energy expenditure (indirect calorimetry)

    Time frame: Timepoint -90 to 150 minutes

    Resting energy expenditure (REE)

  22. Energy expenditure (indirect calorimetry)

    Time frame: Timepoint -90 to 150 minutes

    Respiration exchange rate (RER)

  23. Snacking (ad libitum snack test)

    Time frame: Timepoint 225-235 minutes

    Amount consumed (kcal)

  24. Gallbladder volume (ml)

    Time frame: Timepoint -120 to 180 minutes

    Baseline

  25. Gallbladder volume (ml)

    Time frame: Timepoint -120 to 180 minutes

    AUC

  26. Gallbladder ejection fraction (%)

    Time frame: Timepoint -120 to 180 minutes

    GBEF%

  27. Gallbladder volume (ml)

    Time frame: Timepoint -120 to 180 minutes

    Nadir

  28. Gallbladder volume

    Time frame: Timepoint -120 to 180 minutes

    Time to nadir (min)

  29. Plasma concentrations of glucagon

    Time frame: Timepoint -95 to 180 minutes

    Baseline

  30. Plasma concentrations of glucagon

    Time frame: Timepoint -95 to 180 minutes

    bsAUC

  31. Plasma concentrations of GLP-1

    Time frame: Timepoint -95 to 180 minutes

    Baseline

  32. Plasma concentrations of GLP-1

    Time frame: Timepoint -95 to 180 minutes

    bsAUC

  33. Plasma concentrations of GIP

    Time frame: Timepoint -95 to 180 minutes

    Baseline

  34. Plasma concentrations of GIP

    Time frame: Timepoint -95 to 180 minutes

    bsAUC

  35. Plasma concentrations of peptide YY

    Time frame: Timepoint -95 to 180 minutes

    Baseline

  36. Plasma concentrations of peptide YY

    Time frame: Timepoint -95 to 180 minutes

    bsAUC

  37. Plasma concentrations of leptin

    Time frame: Timepoint -95 to 180 minutes

    Baseline

  38. Plasma concentrations of leptin

    Time frame: Timepoint -95 to 180 minutes

    bsAUC

  39. Plasma concentrations of ghrelin

    Time frame: Timepoint -95 to 180 minutes

    Baseline

  40. Plasma concentrations of ghrelin

    Time frame: Timepoint -95 to 180 minutes

    bsAUC

  41. Plasma concentrations of secretin

    Time frame: Timepoint -95 to 180 minutes

    Baseline

  42. Plasma concentrations of secretin

    Time frame: Timepoint -95 to 180 minutes

    bsAUC

  43. Gastric emptying (paracetamol absorption method)

    Time frame: Timepoint -95 to 180 minutes

    Baseline

  44. Gastric emptying (paracetamol absorption method)

    Time frame: Timepoint -95 to 180 minutes

    bsAUC

  45. Circulating levels of total amino acids

    Time frame: Timepoint -95 to 180 minutes

    Baseline

  46. Circulating levels of total amino acids

    Time frame: Timepoint -95 to 180 minutes

    bsAUC

  47. Lipid profile

    Time frame: Timepoint -95 to 180 minutes

    Baseline

  48. Lipid profile

    Time frame: Timepoint -95 to 180 minutes

    bsAUC

  49. Circulating levels of CTx

    Time frame: Timepoint -95 to 180 minutes

    Baseline

  50. Circulating levels of CTx

    Time frame: Timepoint -95 to 180 minutes

    bsAUC

  51. Circulating levels of P1NP

    Time frame: Timepoint -95 to 180 minutes

    Baseline

  52. Circulating levels of P1NP

    Time frame: Timepoint -95 to 180 minutes

    bsAUC

  53. Circulating levels of PTH

    Time frame: Timepoint -95 to 180 minutes

    Baseline

  54. Circulating levels of PTH

    Time frame: Timepoint -95 to 180 minutes

    bsAUC

  55. Circulating levels of calcium

    Time frame: Timepoint -95 to 180 minutes

    Baseline

  56. Circulating levels of calcium

    Time frame: Timepoint -95 to 180 minutes

    bsAUC

  57. Desire for specific foods

    Time frame: Timepoint -100 to 160 minutes

    VAS (0-100 mm). Baseline

  58. Desire for specific foods

    Time frame: Timepoint -100 to 160 minutes

    VAS (0-100 mm). bsAUC

  59. Duration of ad libitum meal

    Time frame: Timepoint 190-220 minutes

    Minutes

  60. Water intake during ad libitum meal

    Time frame: Timepoint 190-220 minutes

    ml

  61. Blood pressure

    Time frame: Timepoint -75 to 185 minutes and timpoint 240 minutes

    Baseline

  62. Blood pressure

    Time frame: Timepoint -75 to 185 minutes and timpoint 240 minutes

    bsAUC

  63. Heart rate

    Time frame: Timepoint -75 to 185 minutes and timpoint 240 minutes

    Baseline

  64. Heart rate

    Time frame: Timepoint -75 to 185 minutes and timpoint 240 minutes

    bsAUC

  65. Plasma concentrations of creatinine

    Time frame: Timepoint -95 and 235 minutes

    Baseline

  66. Plasma concentrations of creatinine

    Time frame: Timepoint -95 and 235 minutes

    End-infusion

  67. Plasma concentrations of potassium

    Time frame: Timepoint -95 and 235 minutes

    Baseline

  68. Plasma concentrations of potassium

    Time frame: Timepoint -95 and 235 minutes

    bsAUC

  69. Plasma concentrations of sodium

    Time frame: Timepoint -95 and 235 minutes

    Baseline

  70. Plasma concentrations of sodium

    Time frame: Timepoint -95 and 235 minutes

    End-infusion

  71. Happiness (Oxford Happiness Questionnaire (translated to Danish))

    Time frame: Timepoint -65 and 160 minutes

    Points on scale from 29-174

  72. Circulating levels of high-sensitive C-reactive protein (hsCRP)

    Time frame: Timepoint -95 and 235 minutes

    Baseline

  73. Circulating levels of C-reactive protein (hsCRP)

    Time frame: Timepoint -95 and 235 minutes

    End-infusion

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Registry information

Acronym: FOxy

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 3, 2024
Registry last updated
Mar 27, 2025

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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