AzTrials
AzTrials

Metabolic SyndromeMETNCT05884437

The Effects of Chiropractic in Adults With Metabolic Syndrome

A study testing Chiropractic adjustment in people with Metabolic Syndrome, run by Life University at 1 site in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
Search all trials

Trial summary

The purpose of this study is to assess the feasibility of our study procedures/protocols and to look at the potential effects of chiropractic care on people with metabolic syndrome. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metabolic Syndrome
What is being tested?
Chiropractic adjustment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
1 Jan 2025to 16 Dec 2025
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Individuals over the age of 18
  • Individuals who can wear an EEG net for 30 minutes
  • Individuals who can sit quietly for at least 15 minutes
  • Individuals who can walk unassisted for up to 10 minutes
  • Individuals who can provide informed consent
  • Individuals who meet 3 of the 5 following criteria:
Show all 11Show fewer
  • Elevated waist circumference (>40 in/102 cm if male and >35 in/88cm if female)
  • Elevated triglycerides (>150 mg/dL) or drug treatment for elevated triglycerides
  • Reduced HDL-cholesterol (<40mg/dL if male and <50 mg/dL if female) or drug treatment to increase HDL-C
  • Elevated blood pressure (>130 mm Hg systolic BP or >85 mm Hg diastolic BP) or drug treatment to reduce blood pressure
  • Elevated fasting glucose (>100 mg/dL) or drug treatment to reduce blood glucose

Who cannot join

  • Individuals with a known disorder resulting in syncope/fainting during postural changes (e.g., POTS, orthostatic hypotension)
  • Individuals with impaired function of the dominant hand
  • Individuals with malignant hypertension
  • Individuals with a known heart condition such as arrhythmia that results in an aberrant ECG recording
  • Individuals with any implanted devices (i.e., pacemakers)
  • Individuals with brain aneurysms
Show all 16Show fewer
  • Individuals with a history of epilepsy or stroke that would influence EEG readings
  • Individuals with a diagnosed externalizing or thought disorder (i.e., anti-social disorder, any major personality disorder such as borderline personality disorder, or schizophrenia)
  • Individuals who are on short-acting benzodiazepines which include midazolam \& triazolam
  • Individuals with any serious injury or surgery to the head or torso, or lower body in the last 6 months
  • Individuals with a hearing impairment or hearing aids (due to the auditory stimulus recording being performed)
  • Individuals who are currently pregnant
  • Individuals with current litigation related to a physical, health-related injury
  • Individuals who have been diagnosed with rheumatoid arthritis, osteoporosis or instability of the neck.
  • Individuals with moderate to severe pain on a daily basis
  • Pain on the day of testing rated greater than 3/10 on a visual analog scale (VAS)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Dr. Sid E. Williams Center for Chiropractic Research

    Marietta, Georgia, 30067

Other trials in United States

About this study

Official title: The Effects of Chiropractic Care on the Brain, Autonomic Nervous System, Gait, and Patient Reported Outcomes in Adults With Diagnosed or Suspected Metabolic Syndrome: a Proof-of-concept Trial

The purpose of this study is to assess the feasibility of our study procedures/protocols and to look at the potential effects of chiropractic care on people with metabolic syndrome.

Read the detailed description

After providing informed consent, individuals will undergo 6 weeks of chiropractic care. Throughout these 6 weeks there will be three assessments (Day 0, Week 2, and Week 6) that each include the following:

  1. Seated resting recording
  2. Auditory oddball task
  3. Isometric hand grip
  4. Postural challenge
  5. Treadmill walking
  6. Patient-reported outcome surveys

Each assessment will consist of the following recordings:

  1. Electroencephalography [EEG]
  2. Electrodermal activity [EDA]
  3. Impedance cardiography [ICG]
  4. Electrocardiogram [ECG]
Being tested
Chiropractic adjustment
Keywords
Chiropractic, Metabolic syndrome, Spinal manipulation, autonomic nervous system, EEG, patient reported outcomes
Medical subject headings
Metabolic Syndrome

What participants receive

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

  • Chiropractic adjustmentProcedure or surgery

    Participants will receive 6 weeks of chiropractic care. The frequency of care will be determined by the field clinician. Participants will have their spine assessed for the presence of vertebral subluxations per their clinician's normal and customary procedures. The adjustment technique(s) utilized by the field clinician will be at their discretion.

Study groups in NCT05884437
Study groupRoleWhat they receive
ChiropracticExperimentalChiropractic adjustment
Receives: Procedure: Chiropractic adjustment

What is being measured

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

  1. Recruitment rate

    Length of time needed to recruit target number of participants

    Measured: through study completion, an average of 1 year

  2. Participant adherence rate

    Proportion of participants able to adhere to the testing \& treatment schedule

    Measured: through study completion, an average of 1 year

  3. Participant tolerability rate

    Proportion of participants able to perform all aspects of the testing regimen

    Measured: through study completion, an average of 1 year

  4. Participant retention rate

    Proportion of enrolled participants who complete the full testing regimen

    Measured: through study completion, an average of 1 year

  5. Acceptability of treatment regimen for participants

    9-item acceptability questionnaire

    Measured: Week 6

Secondary outcomes (48)

  1. EEG resting state broadband power

    64-channel hydronet cap

    Measured: Day 1

  2. EEG resting state broadband power

    64-channel hydronet cap

    Measured: Week 2

  3. EEG resting state broadband power

    64-channel hydronet cap

    Measured: Week 6

  4. EEG resting state functional connectivity

    64-channel hydronet cap

    Measured: Day 1

  5. EEG resting state functional connectivity

    64-channel hydronet cap

    Measured: Week 2

  6. EEG resting state functional connectivity

    64-channel hydronet cap

    Measured: Week 6

  7. EEG evoked latency

    64-channel hydronet cap during auditory oddball task

    Measured: Day 1

  8. EEG evoked latency

    64-channel hydronet cap during auditory oddball task

    Measured: Week 2

  9. EEG evoked latency

    64-channel hydronet cap during auditory oddball task

    Measured: Week 6

  10. EEG evoked amplitude

    64-channel hydronet cap during auditory oddball task

    Measured: Day 1

  11. EEG evoked amplitude

    64-channel hydronet cap during auditory oddball task

    Measured: Week 2

  12. EEG evoked amplitude

    64-channel hydronet cap during auditory oddball task

    Measured: Week 6

  13. skin conductance level (SCL)

    2 electrodermal activity (EDA) sensors on first and second digits of non-dominant hand

    Measured: Day 1

  14. skin conductance level (SCL)

    2 electrodermal activity (EDA) sensors on first and second digits of non-dominant hand

    Measured: Week 2

  15. skin conductance level (SCL)

    2 electrodermal activity (EDA) sensors on first and second digits of non-dominant hand

    Measured: Week 6

  16. Impedance cardiogram (ICG) pre-ejection period (PEP)

    2 sensors on chest and 2 sensors on back

    Measured: Day 1

  17. Impedance cardiogram (ICG) pre-ejection period (PEP)

    2 sensors on chest and 2 sensors on back

    Measured: Week 2

  18. Impedance cardiogram (ICG) pre-ejection period (PEP)

    2 sensors on chest and 2 sensors on back

    Measured: Week 6

  19. ECG mean interbeat interval

    3 sensors on torso

    Measured: Day 1

  20. ECG mean interbeat interval

    3 sensors on torso

    Measured: Week 2

  21. ECG mean interbeat interval

    3 sensors on torso

    Measured: Week 6

  22. ECG respiratory sinus arrhythmia (RSA)

    3 sensors on torso

    Measured: Day 1

  23. ECG respiratory sinus arrhythmia (RSA)

    3 sensors on torso

    Measured: Week 2

  24. ECG respiratory sinus arrhythmia (RSA)

    3 sensors on torso

    Measured: Week 6

  25. ECG de-trended fluctuation analysis

    3 sensors on torso

    Measured: Day 1

  26. ECG de-trended fluctuation analysis

    3 sensors on torso

    Measured: Week 2

  27. ECG de-trended fluctuation analysis

    3 sensors on torso

    Measured: Week 6

  28. Impedance cardiogram (ICG) initial systolic time interval (ISTI)

    2 sensors on chest and 2 sensors on back

    Measured: Day 1

  29. Impedance cardiogram (ICG) initial systolic time interval (ISTI)

    2 sensors on chest and 2 sensors on back

    Measured: Week 2

  30. Impedance cardiogram (ICG) initial systolic time interval (ISTI)

    2 sensors on chest and 2 sensors on back

    Measured: Week 6

  31. Electrodermal activity (EDA) non-specific skin conductance responses (SCR)

    2 sensors on first and second digits of non-dominant hand

    Measured: Day 1

  32. Electrodermal activity (EDA) non-specific skin conductance responses (SCR)

    2 sensors on first and second digits of non-dominant hand

    Measured: Week 2

  33. Electrodermal activity (EDA) non-specific skin conductance responses (SCR)

    2 sensors on first and second digits of non-dominant hand

    Measured: Week 6

  34. Electrodermal activity (EDA) power spectral density (PSD)

    2 sensors on first and second digits of non-dominant hand

    Measured: Day 1

  35. Electrodermal activity (EDA) power spectral density (PSD)

    2 sensors on first and second digits of non-dominant hand

    Measured: Week 2

  36. Electrodermal activity (EDA) power spectral density (PSD)

    2 sensors on first and second digits of non-dominant hand

    Measured: Week 6

  37. Composite Autonomic Symptom Score (COMPASS-31)

    31-item questionnaire

    Measured: Day 0

  38. Composite Autonomic Symptom Score COMPASS-31)

    31-item questionnaire

    Measured: Day 1

  39. Composite Autonomic Symptom Score (COMPASS-31)

    31-item questionnaire

    Measured: Week 2

  40. Composite Autonomic Symptom Score (COMPASS-31)

    31-item questionnaire

    Measured: Week 6

  41. Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog)

    8-item questionnaire

    Measured: Day 0

  42. Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog)

    8-item questionnaire

    Measured: Day 1

  43. Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog)

    8-item questionnaire

    Measured: Week 2

  44. Patient-Reported Outcomes Measurement Information System Cognitive Abilities and Cognitive Concerns Scale (PROMIS-Cog)

    8-item questionnaire

    Measured: Week 6

  45. Perceived Stress Scale (PSS)

    10-item questionnaire

    Measured: Day 0

  46. Perceived Stress Scale (PSS)

    10-item questionnaire

    Measured: Day 1

  47. Perceived Stress Scale (PSS)

    10-item questionnaire

    Measured: Week 2

  48. Perceived Stress Scale (PSS)

    10-item questionnaire

    Measured: Week 6

Timeline

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

  1. First posted1 Jun 2023
  2. Study start1 Jan 2025 (estimated)
  3. Primary completion1 Jul 2025 (estimated)
  4. Study completion16 Dec 2025 (estimated)

Why it stopped: Prioritizing other studies

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
Other
Allocation
Not applicable
Intervention model
Single group
Model description
Single-arm pilot
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05884437
Sponsor's protocol ID
I-0023
Acronym
MET
Status last verified
Aug 2024
First submitted
16 Feb 2023
Last updated
27 Aug 2024
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 Chiropractic adjustment in people with Metabolic Syndrome, run by Life University at 1 site in United States.

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 11 inclusion and 16 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: paused, as of the sponsor's last update on 27 Aug 2024. 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 United States. 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?

Results are not available in the source record.

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?

Recruitment rate (time frame: through study completion, an average of 1 year). The study lists 5 primary outcomes in all. 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 NCT05884437.

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 Aug 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in