Cardiovascular DiseaseFEELGOODNCT01059760
Expression of Longevity Genes in Response to Extended Fasting
A study testing Fasting First and Fed First in people with Cardiovascular Disease, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of fasting on physical changes associated with cardiovascular disease. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Fasting First and Fed First
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Oct 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The volunteer (male or non-pregnant female, any ethnicity) must be >18 years of age.
- The volunteer must either have a body mass index of 25.0-35.0 kg/m2 or the combination of a body mass index of 18.5-24.9 kg/m2 and two or more previously or currently measured symptoms of the metabolic syndrome (fasting glucose≥110 mg/dL, triglycerides≥150 mg/dL, high-density lipoprotein cholesterol<40 mg/dL in males or <50 mg/dL in females, systolic blood pressure≥130 mmHg or diastolic blood pressure≥85 mmHg, or waist circumference≥40 inches in males or ≥36 inches in females [glucose and cholesterol levels may be self-reported]).
- The volunteer has not routinely participated in caloric restriction (deliberate limitation of caloric intake of <80% than the FDA-recommended daily caloric intake) within the last 2 years, has not participated in extended fasting (>12 hours at a time) for at least a year, and does not deliberately skip meals as a routine dietary practice.
Who cannot join
- Body mass index <18.5 or >35 kg/m2.
- Current active cancer treatment, treatment with immunosuppressive medications, or solid organ transplantation within 1 year.
- Presence of immunosuppressive disease, myocardial infarction, peripheral vascular disease, or stroke within the past year.
- Use of insulin.
- Although it is unlikely fasting will harm the pregnant or lactating woman, the dietary restrictions placed on the participant for the duration of the study may conflict with dietary recommendations for pregnant or lactating women. Women of child bearing potential, therefore, will meet an exclusion if they become pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Intermountain Medical Center
Murray, Utah, 84107-5701
About this study
The purpose of this study is to evaluate the effect of fasting on physical changes associated with cardiovascular disease.
Read the detailed description
Coronary heart disease (CHD) is the largest contributor to morbidity and mortality in the Western world and is associated with high-calorie diet, high body mass, and a variety of other factors. CHD can lead to myocardial infarction (MI) and other embolic events. A growing body of evidence suggests that relatively low caloric intake in the diets of a variety of animals increases longevity and preliminary evidence among humans indicates that such caloric restriction reduces risk factors for CHD, including cholesterol levels, blood pressure, glucose, and obesity. Caloric restriction has also been shown to alter the expression of certain genes, especially the forkhead box (FOX) O and sirtuin (SIRT) genes whose over-expression has been shown to increase longevity in animal models. Extended avoidance of caloric intake, also called fasting or short-term starvation, has been shown to increase expression of the FOXA genes that have similar sequence and function as the FOXO genes and that have been shown to increase longevity among animals regardless of FOXO function. We recently demonstrated that the risk of CHD was significantly lower among patients who reported a history of routine periodic extended fasting. The two primary hypotheses for this observation are that fasting may improve individual ability to control dietary intake or that fasting may initiate a cascade of protective mechanisms that preserve cellular and metabolic health.
- Conditions
- Cardiovascular Disease
- Being tested
- Fasting First, Fed First
- Keywords
- Fasting, Short-term starvation, Diet, Coronary artery disease
- Medical subject headings
- Cardiovascular Diseases, Fasting, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasting FirstBehavioural
28±4 hours of water-only fasting followed by 28±4 hours fed
Fed FirstBehavioural
28± 4 hours fed followed by 28± 4 hours of fasting
| Study group | Role | What they receive |
|---|---|---|
| Fasting Day First | Other | 28±4 hours of water-only fasting followed by 28±4 hours fed Receives: Behavioral: Fasting First |
| Fed Day First | Other | 28± 4 hours fed followed by 28± 4 hours of fasting Receives: Behavioral: Fed First |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Participant Glucose When Fasting and Fed
Measured: Baseline and 3 days
Change From Baseline in Participant Human Growth Hormone (HGH) When Fasting and Fed
Measured: Baseline and 3 days
Change From Baseline in Participant Insulin When Fasting and Fed
Measured: Baseline and 3 days
Change From Baseline in Participant Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) When Fasting and Fed
HOMA-IR is used to measure the severity of insulin resistance. Healthy Range: 1.0 (0.5-1.4) Less than 1.0 is optimal Above 1.9 indicates early insulin resistance Above 2.9 indicates significant insulin resistance
Measured: Baseline and 3 days
Change From Baseline in Participant Glycogen-Like Protein-1 (GLP-1) When Fasting and Fed
Measured: Baseline and 3 days
Change From Baseline in Participant Adiponectin When Fasting and Fed
Measured: Baseline and 3 days
Change From Baseline in Participant Fibroblast Growth Factor-21 (FGF-21) When Fasting and Fed
Measured: Baseline and 3 days
Change From Baseline in Participant White Blood Cell Count (WBC) When Fasting and Fed
Measured: Baseline and 3 days
Change From Baseline in Participant Hemoglobin When Fasting and Fed
Measured: Baseline and 3 days
Change From Baseline in Participant Red Blood Cell Count (RBC) When Fasting and Fed
Measured: Baseline and 3 days
Change From Baseline in Participant Hematocrit When Fasting and Fed
Measured: Baseline and 3 days
Change From Baseline in Participant Platelet Count When Fasting and Fed
Measured: Baseline and 3 days
Change From Baseline in Participant Mean Corpuscular Volume (MCV) When Fasting and Fed
Measured: Baseline and 3 days
Change From Baseline in Participant Mean Corpuscular Hemoglobin (MCH) When Fasting and Fed
Measured: Baseline and 3 days
Change From Baseline in Participant Mean Corpuscular Hemoglobin Concentration (MCHC) When Fasting and Fed
Measured: Baseline and 3 days
Change From Baseline in Participant Red Cell Distribution Width (RDW) When Fasting and Fed
Measured: Baseline and 3 days
Change From Baseline in Participant Mean Platelet Volume (MPV) When Fasting and Fed
Measured: Baseline and 3 days
Change From Baseline in Participant Bicarbonate When Fasting and Fed
Measured: Baseline and 3 days
Change From Baseline in Participant Sodium When Fasting and Fed
Measured: Baseline and 3 days
Change From Baseline in Participant Chloride When Fasting and Fed
Measured: Baseline and 3 days
Change From Baseline in Participant Blood Urea Nitrogen (BUN) When Fasting and Fed
Measured: Baseline and 3 days
Change From Baseline in Participant Calcium When Fasting and Fed
Measured: Baseline and 3 days
Change From Baseline in Participant Potassium When Fasting and Fed
Measured: Baseline and 3 days
Change From Baseline in Participant Creatinine When Fasting and Fed
Measured: Baseline and 3 days
Change From Baseline in Participant Total Cholesterol (TC) When Fasting and Fed
Measured: Baseline and 3 days
Change From Baseline in Participant Low-Density Lipoprotein Cholesterol (LDL-C) When Fasting and Fed
Measured: Baseline and 3 days
Change From Baseline in Participant High-Density Lipoprotein Cholesterol (HDL-C) When Fasting and Fed
Measured: Baseline and 3 days
Change From Baseline in Participant Triglycerides When Fasting and Fed
Measured: Baseline and 3 days
Change From Baseline in Participant TC/HDL Ratio When Fasting and Fed
Measured: Baseline and 3 days
Change From Baseline in Participant Weight When Fasting and Fed
Measured: Baseline and 3 days
Change From Baseline in Participant Waist Circumference When Fasting and Fed
Measured: Baseline and 3 days
Change From Baseline in Participant Systolic Blood Pressure (SBP), Supine When Fasting and Fed
Measured: Baseline and 3 days
Change From Baseline in Participant Diastolic Blood Pressure (DBP), Supine When Fasting and Fed
Measured: Baseline and 3 days
Change From Baseline in Participant High Sensitivity C-Reactive Protein (hsCRP) When Fasting and Fed
Measured: Baseline and 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionAug 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin D Horne, PhD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01059760
- Sponsor's protocol ID
- 154-002
- Acronym
- FEELGOOD
- Status last verified
- Mar 2011
- First submitted
- 28 Jan 2010
- Last updated
- 17 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Horne BD, May HT, Anderson JL, Kfoury AG, Bailey BM, McClure BS, Renlund DG, Lappe DL, Carlquist JF, Fisher PW, Pearson RR, Bair TL, Adams TD, Muhlestein JB; Intermountain Heart Collaborative Study. Usefulness of routine periodic fasting to lower risk of coronary artery disease in patients undergoing coronary angiography. Am J Cardiol. 2008 Oct 1;102(7):814-819. doi: 10.1016/j.amjcard.2008.05.021. Epub 2008 Jul 10.
PubMed 18805103Horne BD, Anderson JL, May HT, Bair TL, Le VT, Iverson L, Knowlton KU, Muhlestein JB. Weight loss-independent changes in human growth hormone during water-only fasting: a secondary evaluation of a randomized controlled trial. Front Endocrinol (Lausanne). 2025 Feb 7;15:1401780. doi: 10.3389/fendo.2024.1401780. eCollection 2024.
PubMed 39991046Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.
PubMed 33512717Horne BD, Muhlestein JB, Lappe DL, May HT, Carlquist JF, Galenko O, Brunisholz KD, Anderson JL. Randomized cross-over trial of short-term water-only fasting: metabolic and cardiovascular consequences. Nutr Metab Cardiovasc Dis. 2013 Nov;23(11):1050-7. doi: 10.1016/j.numecd.2012.09.007. Epub 2012 Dec 7.
PubMed 23220077
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of Longevity Genes in Response to Extended Fasting
- ClinicalTrials.gov ID
- NCT01059760
- Acronym / sponsor ID
- FEELGOOD / 154-002
- Conditions
- Cardiovascular Disease
- Keywords
- Fasting, Short-term starvation, Diet, Coronary artery disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Study start
- Jan 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 1 Feb 2010 (estimated)
- Results
- Posted 17 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect of fasting on physical changes associated with cardiovascular disease.
Detailed description
Coronary heart disease (CHD) is the largest contributor to morbidity and mortality in the Western world and is associated with high-calorie diet, high body mass, and a variety of other factors. CHD can lead to myocardial infarction (MI) and other embolic events. A growing body of evidence suggests that relatively low caloric intake in the diets of a variety of animals increases longevity and preliminary evidence among humans indicates that such caloric restriction reduces risk factors for CHD, including cholesterol levels, blood pressure, glucose, and obesity. Caloric restriction has also been shown to alter the expression of certain genes, especially the forkhead box (FOX) O and sirtuin (SIRT) genes whose over-expression has been shown to increase longevity in animal models. Extended avoidance of caloric intake, also called fasting or short-term starvation, has been shown to increase expression of the FOXA genes that have similar sequence and function as the FOXO genes and that have been shown to increase longevity among animals regardless of FOXO function. We recently demonstrated that the risk of CHD was significantly lower among patients who reported a history of routine periodic extended fasting. The two primary hypotheses for this observation are that fasting may improve individual ability to control dietary intake or that fasting may initiate a cascade of protective mechanisms that preserve cellular and metabolic health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fasting Day First | Other | Behavioral: Fasting First28±4 hours of water-only fasting followed by 28±4 hours fed |
| Fed Day First | Other | Behavioral: Fed First28± 4 hours fed followed by 28± 4 hours of fasting |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The volunteer (male or non-pregnant female, any ethnicity) must be >18 years of age.
- The volunteer must either have a body mass index of 25.0-35.0 kg/m2 or the combination of a body mass index of 18.5-24.9 kg/m2 and two or more previously or currently measured symptoms of the metabolic syndrome (fasting glucose≥110 mg/dL, triglycerides≥150 mg/dL, high-density lipoprotein cholesterol<40 mg/dL in males or <50 mg/dL in females, systolic blood pressure≥130 mmHg or diastolic blood pressure≥85 mmHg, or waist circumference≥40 inches in males or ≥36 inches in females [glucose and cholesterol levels may be self-reported]).
- The volunteer has not routinely participated in caloric restriction (deliberate limitation of caloric intake of <80% than the FDA-recommended daily caloric intake) within the last 2 years, has not participated in extended fasting (>12 hours at a time) for at least a year, and does not deliberately skip meals as a routine dietary practice.
Key exclusion criteria (5 listed)
- Body mass index <18.5 or >35 kg/m2.
- Current active cancer treatment, treatment with immunosuppressive medications, or solid organ transplantation within 1 year.
- Presence of immunosuppressive disease, myocardial infarction, peripheral vascular disease, or stroke within the past year.
- Use of insulin.
- Although it is unlikely fasting will harm the pregnant or lactating woman, the dietary restrictions placed on the participant for the duration of the study may conflict with dietary recommendations for pregnant or lactating women. Women of child bearing potential, therefore, will meet an exclusion if they become pregnant.
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 |
|---|---|---|
| Fasting First28±4 hours of water-only fasting followed by 28±4 hours fed | Behavioural | Fasting Day First |
| Fed First28± 4 hours fed followed by 28± 4 hours of fasting | Behavioural | Fed Day First |
Primary outcome
Change From Baseline in Participant Glucose When Fasting and Fed
Time frame: Baseline and 3 days
Change From Baseline in Participant Human Growth Hormone (HGH) When Fasting and Fed
Time frame: Baseline and 3 days
Change From Baseline in Participant Insulin When Fasting and Fed
Time frame: Baseline and 3 days
Change From Baseline in Participant Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) When Fasting and Fed
Time frame: Baseline and 3 days
HOMA-IR is used to measure the severity of insulin resistance. Healthy Range: 1.0 (0.5-1.4) Less than 1.0 is optimal Above 1.9 indicates early insulin resistance Above 2.9 indicates significant insulin resistance
Change From Baseline in Participant Glycogen-Like Protein-1 (GLP-1) When Fasting and Fed
Time frame: Baseline and 3 days
Change From Baseline in Participant Adiponectin When Fasting and Fed
Time frame: Baseline and 3 days
Change From Baseline in Participant Fibroblast Growth Factor-21 (FGF-21) When Fasting and Fed
Time frame: Baseline and 3 days
Change From Baseline in Participant White Blood Cell Count (WBC) When Fasting and Fed
Time frame: Baseline and 3 days
Change From Baseline in Participant Hemoglobin When Fasting and Fed
Time frame: Baseline and 3 days
Change From Baseline in Participant Red Blood Cell Count (RBC) When Fasting and Fed
Time frame: Baseline and 3 days
Change From Baseline in Participant Hematocrit When Fasting and Fed
Time frame: Baseline and 3 days
Change From Baseline in Participant Platelet Count When Fasting and Fed
Time frame: Baseline and 3 days
Change From Baseline in Participant Mean Corpuscular Volume (MCV) When Fasting and Fed
Time frame: Baseline and 3 days
Change From Baseline in Participant Mean Corpuscular Hemoglobin (MCH) When Fasting and Fed
Time frame: Baseline and 3 days
Change From Baseline in Participant Mean Corpuscular Hemoglobin Concentration (MCHC) When Fasting and Fed
Time frame: Baseline and 3 days
Change From Baseline in Participant Red Cell Distribution Width (RDW) When Fasting and Fed
Time frame: Baseline and 3 days
Change From Baseline in Participant Mean Platelet Volume (MPV) When Fasting and Fed
Time frame: Baseline and 3 days
Change From Baseline in Participant Bicarbonate When Fasting and Fed
Time frame: Baseline and 3 days
Change From Baseline in Participant Sodium When Fasting and Fed
Time frame: Baseline and 3 days
Change From Baseline in Participant Chloride When Fasting and Fed
Time frame: Baseline and 3 days
Change From Baseline in Participant Blood Urea Nitrogen (BUN) When Fasting and Fed
Time frame: Baseline and 3 days
Change From Baseline in Participant Calcium When Fasting and Fed
Time frame: Baseline and 3 days
Change From Baseline in Participant Potassium When Fasting and Fed
Time frame: Baseline and 3 days
Change From Baseline in Participant Creatinine When Fasting and Fed
Time frame: Baseline and 3 days
Change From Baseline in Participant Total Cholesterol (TC) When Fasting and Fed
Time frame: Baseline and 3 days
Change From Baseline in Participant Low-Density Lipoprotein Cholesterol (LDL-C) When Fasting and Fed
Time frame: Baseline and 3 days
Change From Baseline in Participant High-Density Lipoprotein Cholesterol (HDL-C) When Fasting and Fed
Time frame: Baseline and 3 days
Change From Baseline in Participant Triglycerides When Fasting and Fed
Time frame: Baseline and 3 days
Change From Baseline in Participant TC/HDL Ratio When Fasting and Fed
Time frame: Baseline and 3 days
Change From Baseline in Participant Weight When Fasting and Fed
Time frame: Baseline and 3 days
Change From Baseline in Participant Waist Circumference When Fasting and Fed
Time frame: Baseline and 3 days
Change From Baseline in Participant Systolic Blood Pressure (SBP), Supine When Fasting and Fed
Time frame: Baseline and 3 days
Change From Baseline in Participant Diastolic Blood Pressure (DBP), Supine When Fasting and Fed
Time frame: Baseline and 3 days
Change From Baseline in Participant High Sensitivity C-Reactive Protein (hsCRP) When Fasting and Fed
Time frame: Baseline and 3 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18805103Horne BD, May HT, Anderson JL, Kfoury AG, Bailey BM, McClure BS, Renlund DG, Lappe DL, Carlquist JF, Fisher PW, Pearson RR, Bair TL, Adams TD, Muhlestein JB; Intermountain Heart Collaborative Study. Usefulness of routine periodic fasting to lower risk of coronary artery disease in patients undergoing coronary angiography. Am J Cardiol. 2008 Oct 1;102(7):814-819. doi: 10.1016/j.amjcard.2008.05.021. Epub 2008 Jul 10.
- Derived from this study: PubMed 39991046Horne BD, Anderson JL, May HT, Bair TL, Le VT, Iverson L, Knowlton KU, Muhlestein JB. Weight loss-independent changes in human growth hormone during water-only fasting: a secondary evaluation of a randomized controlled trial. Front Endocrinol (Lausanne). 2025 Feb 7;15:1401780. doi: 10.3389/fendo.2024.1401780. eCollection 2024.
- Derived from this study: PubMed 33512717Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.
- Derived from this study: PubMed 23220077Horne BD, Muhlestein JB, Lappe DL, May HT, Carlquist JF, Galenko O, Brunisholz KD, Anderson JL. Randomized cross-over trial of short-term water-only fasting: metabolic and cardiovascular consequences. Nutr Metab Cardiovasc Dis. 2013 Nov;23(11):1050-7. doi: 10.1016/j.numecd.2012.09.007. Epub 2012 Dec 7.
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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.
Benjamin D Horne, PhD principal investigator
Intermountain Health Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting First and Fed First in people with Cardiovascular Disease, run by Intermountain Health Care, Inc. 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 3 inclusion and 5 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 17 Jul 2017. 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?
Yes. Results are posted in the registry (first posted 17 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Participant Glucose When Fasting and Fed (time frame: Baseline and 3 days). The study lists 34 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 NCT01059760, which also lists 4 linked publications.
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 17 Jul 2017.