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AdiposityFOxyNCT06189001

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

A study testing Oxytocin in people with Adiposity, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Adiposity
What is being tested?
Oxytocin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
25 participants
Where
1 siteDenmark
Study dates
1 Jan 2024to 4 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Center for Clinical Metabolisk Research

    Hellerup, 2100

Other trials in Denmark

About this study

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.

Read the detailed description

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.

Conditions
Adiposity
Being tested
Oxytocin, Placebo (saline)
Keywords
oxytocin, appetite regulation, gastrointestinal motility, energy expenditure
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OxytocinDrug

    Intravenous oxytocin 0.2 IU/min during experimental days

  • Placebo (saline)Other

    Intravenous saline during experimental days

Study groups in NCT06189001
Study groupRoleWhat they receive
OxytocinExperimentalIntravenous oxytocin 0.2 IU/minute for 300 minutes Approx. 500 ml
Receives: Drug: Oxytocin
PlaceboOtherintravenous saline (0.9% NaCl) infusion for 300 minutes Approx. 500 ml
Receives: Other: Placebo (saline)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ad libitum food intake

    Amount consumed (kcal)

    Measured: Timepoint 190-220 minutes

Secondary outcomes (73)

  1. Ad libitum food intake

    Amount consumed (kcal/kg)

    Measured: Timepoint 190-220 minutes

  2. Sensations of hunger

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

    Measured: Timepoint -100 to 160 minutes

  3. Sensations of satiety

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

    Measured: Timepoint -100 to 160 minutes

  4. Sensations of fullness

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

    Measured: Timepoint -100 to 160 minutes

  5. Sensations of prospective food intake

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

    Measured: Timepoint -100 to 160 minutes

  6. Sensations of nausea

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

    Measured: Timepoint -100 to 160 minutes

  7. Sensations of thirst

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

    Measured: Timepoint -100 to 160 minutes

  8. Sensations of comfort

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

    Measured: Timepoint -100 to 160 minutes

  9. Composite appetite score

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

    Measured: Timepoint -100 to 160

  10. Plasma concentrations of glucose

    Baseline

    Measured: Timepoint -95 to 180 minutes

  11. Plasma concentrations of glucose

    bsAUC

    Measured: Timepoint -95 to 180 minutes

  12. Plasma concentrations of glucose

    Peak value

    Measured: Timepoint -95 to 180 minutes

  13. Serum concentrations of insulin

    Baseline

    Measured: Timepoint -95 to 180 minutes

  14. Serum concentrations of insulin

    bsAUC

    Measured: Timepoint -95 to 180 minutes

  15. Serum concentrations of C-peptide

    Baseline

    Measured: Timepoint -95 to 180 minutes

  16. Serum concentrations of C-peptide

    bsAUC

    Measured: Timepoint -95 to 180 minutes

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

    Baseline

    Measured: Timepoint -95 to 180 minutes

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

    bsAUC

    Measured: Timepoint -95 to 180 minutes

  19. Plasma concentrations of cholecystokinin

    Baseline

    Measured: Timepoint -95 to 180 minutes

  20. Plasma concentrations of cholecystokinin

    bsAUC

    Measured: Timepoint -95 to 180 minutes

  21. Energy expenditure (indirect calorimetry)

    Resting energy expenditure (REE)

    Measured: Timepoint -90 to 150 minutes

  22. Energy expenditure (indirect calorimetry)

    Respiration exchange rate (RER)

    Measured: Timepoint -90 to 150 minutes

  23. Snacking (ad libitum snack test)

    Amount consumed (kcal)

    Measured: Timepoint 225-235 minutes

  24. Gallbladder volume (ml)

    Baseline

    Measured: Timepoint -120 to 180 minutes

  25. Gallbladder volume (ml)

    AUC

    Measured: Timepoint -120 to 180 minutes

  26. Gallbladder ejection fraction (%)

    GBEF%

    Measured: Timepoint -120 to 180 minutes

  27. Gallbladder volume (ml)

    Nadir

    Measured: Timepoint -120 to 180 minutes

  28. Gallbladder volume

    Time to nadir (min)

    Measured: Timepoint -120 to 180 minutes

  29. Plasma concentrations of glucagon

    Baseline

    Measured: Timepoint -95 to 180 minutes

  30. Plasma concentrations of glucagon

    bsAUC

    Measured: Timepoint -95 to 180 minutes

  31. Plasma concentrations of GLP-1

    Baseline

    Measured: Timepoint -95 to 180 minutes

  32. Plasma concentrations of GLP-1

    bsAUC

    Measured: Timepoint -95 to 180 minutes

  33. Plasma concentrations of GIP

    Baseline

    Measured: Timepoint -95 to 180 minutes

  34. Plasma concentrations of GIP

    bsAUC

    Measured: Timepoint -95 to 180 minutes

  35. Plasma concentrations of peptide YY

    Baseline

    Measured: Timepoint -95 to 180 minutes

  36. Plasma concentrations of peptide YY

    bsAUC

    Measured: Timepoint -95 to 180 minutes

  37. Plasma concentrations of leptin

    Baseline

    Measured: Timepoint -95 to 180 minutes

  38. Plasma concentrations of leptin

    bsAUC

    Measured: Timepoint -95 to 180 minutes

  39. Plasma concentrations of ghrelin

    Baseline

    Measured: Timepoint -95 to 180 minutes

  40. Plasma concentrations of ghrelin

    bsAUC

    Measured: Timepoint -95 to 180 minutes

  41. Plasma concentrations of secretin

    Baseline

    Measured: Timepoint -95 to 180 minutes

  42. Plasma concentrations of secretin

    bsAUC

    Measured: Timepoint -95 to 180 minutes

  43. Gastric emptying (paracetamol absorption method)

    Baseline

    Measured: Timepoint -95 to 180 minutes

  44. Gastric emptying (paracetamol absorption method)

    bsAUC

    Measured: Timepoint -95 to 180 minutes

  45. Circulating levels of total amino acids

    Baseline

    Measured: Timepoint -95 to 180 minutes

  46. Circulating levels of total amino acids

    bsAUC

    Measured: Timepoint -95 to 180 minutes

  47. Lipid profile

    Baseline

    Measured: Timepoint -95 to 180 minutes

  48. Lipid profile

    bsAUC

    Measured: Timepoint -95 to 180 minutes

  49. Circulating levels of CTx

    Baseline

    Measured: Timepoint -95 to 180 minutes

  50. Circulating levels of CTx

    bsAUC

    Measured: Timepoint -95 to 180 minutes

  51. Circulating levels of P1NP

    Baseline

    Measured: Timepoint -95 to 180 minutes

  52. Circulating levels of P1NP

    bsAUC

    Measured: Timepoint -95 to 180 minutes

  53. Circulating levels of PTH

    Baseline

    Measured: Timepoint -95 to 180 minutes

  54. Circulating levels of PTH

    bsAUC

    Measured: Timepoint -95 to 180 minutes

  55. Circulating levels of calcium

    Baseline

    Measured: Timepoint -95 to 180 minutes

  56. Circulating levels of calcium

    bsAUC

    Measured: Timepoint -95 to 180 minutes

  57. Desire for specific foods

    VAS (0-100 mm). Baseline

    Measured: Timepoint -100 to 160 minutes

  58. Desire for specific foods

    VAS (0-100 mm). bsAUC

    Measured: Timepoint -100 to 160 minutes

  59. Duration of ad libitum meal

    Minutes

    Measured: Timepoint 190-220 minutes

  60. Water intake during ad libitum meal

    ml

    Measured: Timepoint 190-220 minutes

  61. Blood pressure

    Baseline

    Measured: Timepoint -75 to 185 minutes and timpoint 240 minutes

  62. Blood pressure

    bsAUC

    Measured: Timepoint -75 to 185 minutes and timpoint 240 minutes

  63. Heart rate

    Baseline

    Measured: Timepoint -75 to 185 minutes and timpoint 240 minutes

  64. Heart rate

    bsAUC

    Measured: Timepoint -75 to 185 minutes and timpoint 240 minutes

  65. Plasma concentrations of creatinine

    Baseline

    Measured: Timepoint -95 and 235 minutes

  66. Plasma concentrations of creatinine

    End-infusion

    Measured: Timepoint -95 and 235 minutes

  67. Plasma concentrations of potassium

    Baseline

    Measured: Timepoint -95 and 235 minutes

  68. Plasma concentrations of potassium

    bsAUC

    Measured: Timepoint -95 and 235 minutes

  69. Plasma concentrations of sodium

    Baseline

    Measured: Timepoint -95 and 235 minutes

  70. Plasma concentrations of sodium

    End-infusion

    Measured: Timepoint -95 and 235 minutes

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

    Points on scale from 29-174

    Measured: Timepoint -65 and 160 minutes

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

    Baseline

    Measured: Timepoint -95 and 235 minutes

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

    End-infusion

    Measured: Timepoint -95 and 235 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jan 2024
  2. Study start1 Jan 2024
  3. Primary completion4 Sep 2024
  4. Study completion4 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06189001
Sponsor's protocol ID
H-23059585
Acronym
FOxy
Status last verified
May 2024
First submitted
5 Dec 2023
Last updated
27 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Oxytocin in people with Adiposity, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ad libitum food intake (time frame: Timepoint 190-220 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06189001.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.

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