Insulin ResistanceFBHHNCT04507516
Fasting for Brain and Heart Health (FBHH)
An observational study of Insulin Resistance, run by TrueNorth Health Foundation at 1 site in United States.
Trial summary
This pilot study is designed to investigate the effect of water-only fasting and refeeding on the homeostatic model of insulin resistance (HOMA-IR), a measure of insulin resistance. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- Water-only Fasting
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2019to 10 Feb 2020
- Phase
- Observational
- 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 40 to 70 years
- All sexes
- Adult, Older adult
Study population: Overweight and obese, non-diabetic participants recruited from voluntary patients.
Who may be able to join
- Any gender
- 40-70 years old
- Fasting plasma glucose <12 6mg/dL and/or hemoglobin A1c <7%
- Body Mass Index (BMI) >25 kg/m2
- Elect and qualify for a water-only fast of at least 10 consecutive days
- Provide informed consent
Who cannot join
- Active malignancy
- Active inflammatory disorder including classic autoimmune connective tissue (Lupus, Sjogrens, ANCA), multiple sclerosis, and inflammatory bowel disorders (Ulcerative colitis, Crohn's)
- Stroke or heart attack within the last 90 days
Trial locations and contacts
1 site in 1 country.
United States1 site
TrueNorth Health Center
Santa Rosa, California, 95404
About this study
Official title: A Pilot Study on the Effects of Medically Supervised, Water-Only Fasting and Refeeding on Cardiometabolic Risk
This pilot study is designed to investigate the effect of water-only fasting and refeeding on the homeostatic model of insulin resistance (HOMA-IR), a measure of insulin resistance.
Read the detailed description
Ischemic stroke is a leading cause of death and a major public health burden. Data suggests that insulin resistance is a potential risk factor for cardiovascular disease, including ischemic stroke, and that dietary and lifestyle intervention can reduce insulin resistance as well as these disease risks. Nonetheless, current intervention strategies have done little to reduce overall stroke incidence. Therefore, an intervention, such as prolonged medically supervised water-only fasting, might be an effective strategy to both reduce insulin resistance and encourage dietary and lifestyle changes that reduce incidence of stroke.
This pilot study is designed to investigate the effect of water-only fasting and refeeding on the homeostatic model of insulin resistance (HOMA-IR), a measure of insulin resistance. Additionally, the study will assess if markers of cardiovascular health and inflammation change before and after water-only fasting. Water-only fasting participants will be recruited from patients who voluntarily elect to water-only fast for 10 or more consecutive days. Clinical variables and blood will be collected at baseline, every 7th day during fasting and refeeding, and the final day of fasting and refeeding.
- Conditions
- Insulin Resistance
- Being tested
- Water-only Fasting
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water-only FastingOther
Water-only fasting for at least 10 days followed by 5 days of refeed.
| Study group | Role | What they receive |
|---|---|---|
| Water-only Fasting Cohort | Obese/overweight, non-diabetic patients undergoing elective water-only fasting treatment. Receives: Other: Water-only Fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in insulin resistance from baseline
Insulin resistance assessed using serum glucose and insulin to calculate homeostatic model of insulin resistance (HOMA-IR) [fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5]
Measured: Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast
Secondary outcomes (5)
Changes in lipid profile from baseline
Lipid profile assessed using serum to measure cholesterol, triglycerides, high-density lipoprotein (HDL), and low-density lipoprotein (LDL) and reported in mg/dL
Measured: Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast
Changes in weight from baseline
Weight measured on a digital scale and reported in kilograms (kg)
Measured: Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast
Changes in resting systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline
SBP and DBP measured using digital blood pressure device and reported in mmHg
Measured: Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast
Changes in abdominal circumference from baseline
Abdominal circumference measured on bare skin at the minimal waistline with a tension-sensitive, non-elastic tape and reported in centimeters (cm)
Measured: Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast
Changes in high sensitivity C-reactive protein (hsCRP) from baseline
hsCRP assessed using serum and reported in mg/L
Measured: Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start2 Apr 2019
- Primary completion10 Feb 2020
- Study completion10 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- TrueNorth Health Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Toshia R Myers, PhD, Principal investigator, Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04507516
- Sponsor's protocol ID
- TNHF2018-1
- Acronym
- FBHH
- Status last verified
- Aug 2020
- First submitted
- 6 Aug 2020
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on the Effects of Medically Supervised, Water-Only Fasting and Refeeding on Cardiometabolic Risk
- ClinicalTrials.gov ID
- NCT04507516
- Acronym / sponsor ID
- FBHH / TNHF2018-1
- Conditions
- Insulin Resistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- TrueNorth Health FoundationUniversity, hospital or other
- Study start
- 2 Apr 2019 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 11 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study is designed to investigate the effect of water-only fasting and refeeding on the homeostatic model of insulin resistance (HOMA-IR), a measure of insulin resistance.
Detailed description
Ischemic stroke is a leading cause of death and a major public health burden. Data suggests that insulin resistance is a potential risk factor for cardiovascular disease, including ischemic stroke, and that dietary and lifestyle intervention can reduce insulin resistance as well as these disease risks. Nonetheless, current intervention strategies have done little to reduce overall stroke incidence. Therefore, an intervention, such as prolonged medically supervised water-only fasting, might be an effective strategy to both reduce insulin resistance and encourage dietary and lifestyle changes that reduce incidence of stroke.
This pilot study is designed to investigate the effect of water-only fasting and refeeding on the homeostatic model of insulin resistance (HOMA-IR), a measure of insulin resistance. Additionally, the study will assess if markers of cardiovascular health and inflammation change before and after water-only fasting. Water-only fasting participants will be recruited from patients who voluntarily elect to water-only fast for 10 or more consecutive days. Clinical variables and blood will be collected at baseline, every 7th day during fasting and refeeding, and the final day of fasting and refeeding.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Water-only Fasting Cohort | – | Other: Water-only FastingObese/overweight, non-diabetic patients undergoing elective water-only fasting treatment. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Overweight and obese, non-diabetic participants recruited from voluntary patients.
Key inclusion criteria (6 listed)
- Any gender
- 40-70 years old
- Fasting plasma glucose <12 6mg/dL and/or hemoglobin A1c <7%
- Body Mass Index (BMI) >25 kg/m2
- Elect and qualify for a water-only fast of at least 10 consecutive days
Key exclusion criteria (3 listed)
- Active malignancy
- Active inflammatory disorder including classic autoimmune connective tissue (Lupus, Sjogrens, ANCA), multiple sclerosis, and inflammatory bowel disorders (Ulcerative colitis, Crohn's)
- Stroke or heart attack within the last 90 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Water-only FastingWater-only fasting for at least 10 days followed by 5 days of refeed. | Other | Water-only Fasting Cohort |
Primary outcome
Changes in insulin resistance from baseline
Time frame: Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast
Insulin resistance assessed using serum glucose and insulin to calculate homeostatic model of insulin resistance (HOMA-IR) [fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5]
5 secondary outcomes
Changes in lipid profile from baseline
Time frame: Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast
Changes in weight from baseline
Time frame: Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast
Changes in resting systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline
Time frame: Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast
Changes in abdominal circumference from baseline
Time frame: Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast
Changes in high sensitivity C-reactive protein (hsCRP) from baseline
Time frame: Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Toshia R Myers, PhD principal investigator
Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insulin Resistance, run by TrueNorth Health Foundation 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 6 inclusion and 3 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 11 Aug 2020. 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?
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?
Changes in insulin resistance from baseline (time frame: Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2020.