Effect of Vestibular Stimulation on Fat Consumption and Energy Expenditure as Assessed Using Indirect Calorimetry

Completed · Not applicable · Has a placebo group

Conditions studied: Obesity, Metabolic Syndrome

In brief

There is an ongoing and worsening problem with obesity in the developed, and much of the developing world. Although it has long been realized that Western diets that are rich in sugar and fat play an important role in this, it has only recently been realized that exposure to these diets, particularly in childhood, can damage the part of the brain that determines how much fat there is in the body. The result of this damage is that the so-called "set-point" for fat in this part of the brain is pushed upwards. There is a lot of evidence from animals that activating the brain's balance (vestibular) system pushes this set-point for fat downwards to cause fat loss, probably because this "tricks" the brain into thinking that there is increased physical activity. The aim of this study is to see whether non-invasive electrical stimulation of the vestibular system in human participants causes a change in metabolism of fat and/or energy expenditure, which, if regulated upwards, would suggest this could be used as a means of reducing body fat in humans.

Key facts

Study ID

NCT03138382

Run by

University of California, San Diego

People needed

20

Starts

2017-08-25

Expected to finish

2018-03-01

Last updated by the study team

2019-06-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Signed informed consent
• Body mass index (BMI) > 25 kg/m2
• 18-65 years of age inclusive on starting the study.
• Successfully completed the screening questionnaire.

You may not qualify if…

• History of vestibular dysfunction.
• History of bariatric surgery, fundoplication, gastric resection or major upper-abdominal surgery (acceptable surgeries include cholecystectomy, hysterectomy).
• History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears, or of the head and neck.
• History of weight loss device implantation (e.g. VBloc Maestro or Abiliti).
• Positive response in Physical Activity Readiness Questionnaire.
• Currently taking medication for asthma or other breathing conditions.
• Untreated thyroid disorder (stable treatment for 3 months is acceptable).
• Other endocrinological causes of weight gain (e.g. Cushing's disease, Cushing's syndrome or acromegaly)
• Previous diagnosis of HIV infection or AIDS (HIV is known to cause a vestibular neuropathy which would prevent VeNS from working).
• History of cirrhosis, or liver, kidney or heart failure.
• Chronic pancreatitis.
• Treatment with prescription weight-loss drug therapy in the year before starting the study.
• Tobacco or marijuana smoking in the 6 months prior to study.
• Known genetic cause of obesity (e.g., Prader-Willi Syndrome).
• Diabetes mellitus (Types 1 \& 2).
• Diagnosis of epilepsy or use of anti-epileptic medication within six months of starting the study (e.g. for the treatment of peripheral neuropathy)
• Chronic (more than a month of daily use) treatment with opioid analgesic drugs within the last year.
• Regular use (more than twice a month) of anti-histamine medication.
• Use of oral or intravenous corticosteroid medication within two years of starting the study.
• Use of the beta-blockers atenolol, metoprolol or propranolol within 3 months of starting the study.
• Current use of tricyclic antidepressant medication for whatever reason.
• Current alterations in treatment regimens of anti-depressant medication for whatever reason (other than tricyclic antidepressants) (Note: stable treatment regimen for prior six months acceptable).
• An active diagnosis of cancer.
• A previous myocardial infarction.
• A history of stroke or severe head injury (as defined by a head injury that required intensive care). (In case this damaged the neurological pathways involved in vestibular stimulation).

Where it is running

• UC San Diego — San Diego, California, United States

Full record on ClinicalTrials.gov

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