OverweightNCT04011995
Effects of Intermittent Caloric Restriction in Youth With Cardiometabolic Risk
A study testing Intermittent caloric restriction, Low carbohydrate diet and Health education on reducing the cardiometabolic risk in people with Overweight and Obesity, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
This is a randomized controlled pilot study to evaluate the effects of intermittent caloric restriction compared with low carbohydrate diet in youth with cardiometabolic risk. Read more about this study
- Who is it for?
- Ages 9 to 30 years
- Conditions the study is for
- Overweight, Obesity, Cardiometabolic Risk
- What is being tested?
- Intermittent caloric restriction, Low carbohydrate diet and Health education on reducing the cardiometabolic risk
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 12 Jul 2018to 1 Dec 2021
- 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 9 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Have at least one of the following cardiometabolic abnormalities:
- Overweight or obesity (central obesity or general obesity)
- Prediabetes: impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT)
- Dyslipidemia
- Elevated blood pressure
- Criteria for cardiometabolic abnormalities:
Show all 26Show fewer
- Overweight or obesity
- For subjects (9 ≤ age ≤ 18 years) :
- General obesity: Body mass index higher than the 85th percentile for overweight and the 90th percentile for obesity, based on the references for screening overweight and obesity in Chinese children and adolescents.
- Central obesity: Waist circumference higher than the 90th percentile of the age and gender-specific reference for screening cardiovascular risk factors in Chinese children and adolescents.
- For subjects ( 19 ≤ age ≤ 30 years) :
- General obesity: Body mass index between 24.0 and 27.9 kg/m2 for overweight and ≥28 kg/m2 for obesity.
- Central obesity: Waist circumference ≥85cm for men and ≥80cm for female. Based on recommendation of overweight and obesity in Chinese adults.
- Prediabetes:
- With IFG and/or IGT. IFG: fasting glucose from 5.6 to 6.9 mmol/L; IGT: 2-h glucose in the 75g oral glucose tolerance test from 7.8 to 11.0 mmol/L.
- Based on recommendation of American Diabetes Association.
- Dyslipidemia:
- For subjects (9 ≤ age ≤ 18 years) :
- Triglycerides of ≥1.70 mmol/L or total cholesterol of ≥5.18 mmol/L or lowdensity lipoprotein cholesterol ≥3.37 mmol/L or highdensity lipoprotein cholesterol of ≤1.04 mmol/L. Based on recommendation in Chinese children and adolescents.
- For subjects ( 19 ≤ age ≤ 30 years) :
- Triglycerides of ≥1.7 mmol/L or total cholesterol of ≥5.2 mmol/L or lowdensity lipoprotein cholesterol ≥3.4 mmol/L or highdensity lipoprotein cholesterol of ≤1.0 mmol/L. Based on guideline for the management of dyslipidemia in Chinese adults.
- Elevated blood pressure:
- For subjects (9 ≤ age ≤ 18 years) :
- Blood pressure higher than the 90th percentile of blood pressure age and gender-specific reference standards for Chinese children and adolescents, or blood pressure >120/80 mmHg.
- For subjects ( 19 ≤ age ≤ 30 years) :
- Systolic blood pressure≥120 mmHg and/or diastolic blood pressure ≥80 mmHg. Based on Chinese guidelines for the management of hypertension.
Who cannot join
- Diagnosis of severe diseases such as cardiac insufficiency, severe malnutrition or immunodeficiency.
- History of bariatric surgery.
- Use of antiobesity drugs or supplements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Intermittent Caloric Restriction in Youth With Cardiometabolic Risk: a Randomized Controlled Pilot Study
This is a randomized controlled pilot study to evaluate the effects of intermittent caloric restriction compared with low carbohydrate diet in youth with cardiometabolic risk.
Read the detailed description
The National China Health and Nutrition Survey revealed that 42% of overweight children had at least one cardiovascular metabolic risk, such as hyperglycaemia, dyslipidemia or hypertension. Non-pharmaceutical life style modifications are the recommended intervention to these subjects, including caloric restriction and increased physical activity. However, the problems of poor compliance and metabolic adaptation are well known. Evidences from a number studies in rodent models and human indicated that intermittent caloric restriction (ICR) may stimulate series reactions in human body, including improvement of insulin sensitivity, blood pressure, oxidative stress and inflammation, and may be easier to follow. Evidence from larger human studies is strongly encouraged, while the effects, safety and adherence in chidren and youth need to be studied.
This study is a randomized controlled trial of intermittent caloric restriction versus low carbohydrate diet in youth with cardiometabolic risk over one month period. The intervention is based on the 5:2 diet, which involves caloric restriction for 2 days (consecutive or nonconsecutive, 600kcal/d for male and 500kcal/d for female) per week and unrestricted eating during the other 5 days of the week. For control group, the subjects receive 7 days (consecutive or nonconsecutive) of low carbohydrate diet intervention during the 14-day intervention period,. Carbohydrate intake of low-carbohydrate diet should be controlled as ≤ 50g per day. Total trial duration is one month consisting of a 14-day intervention phase and a 14-day self-maintenance phase. During the maintenance phase, two follow-up electronic questionnaires were conducted.
The study aim to explore effects of the dietary interventions on cardiometabolic markers, inflammatory reaction, oxidative stress and gut microbiome in youth with cardiometabolic risk.
- Conditions
- Overweight, Obesity, Cardiometabolic Risk
- Being tested
- Intermittent caloric restriction, Low carbohydrate diet, Health education on reducing the cardiometabolic risk
- Keywords
- Intermittent caloric restriction, Children, Youth
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent caloric restrictionBehavioural
Also called Intermittent fasting
The intervention is based on the 5:2 diet, which involves caloric restriction for 2 days (consecutive or nonconsecutive, 600kcal/d for male and 500kcal/d for female) per week and unrestricted eating during the other 5 days of the week.
Total trial duration is one month consisting of a 14-day intervention phase and a 14-day self-maintenance phase. During the maintenance phase, two follow-up electronic questionnaires were conducted.
Low carbohydrate dietBehavioural
During the 14-day intervention period, the subjects receive 7 days (consecutive or nonconsecutive) of low carbohydrate diet intervention. Carbohydrate intake of low-carbohydrate diet should be controlled as ≤ 50g per day.
Total trial duration is one month consisting of a 14-day intervention phase and a 14-day self-maintenance phase. During the maintenance phase, two follow-up electronic questionnaires were conducted.
Health education on reducing the cardiometabolic riskBehavioural
Health education is conducted once a week during 14-day dietary intervention for all subjects. Health education including the understanding of cardiovascular disease, how to determine the cardiometabolic risk level, and the lifestyle intervention as caloric restriction and increased physical activity to promote health.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent caloric restriction | Experimental | Not described Receives: Behavioral: Intermittent caloric restriction; Behavioral: Health education on reducing the cardiometabolic risk |
| Low carbohydrate diet | Active comparator | Not described Receives: Behavioral: Low carbohydrate diet; Behavioral: Health education on reducing the cardiometabolic risk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reversal of cardiometabolic abnormalities
The primary outcome is a composite outcome that will be measured by combining multiple reverse outcomes of the following cardiometabolic abnormalities: (1) overweight or obesity, (2) prediabetes, (3) hyperlipidemia and (4) elevated blood pressure. It is defined as occurring if any cardiometabolic abnormality has a reversal outcome at the 14th day of dietary intervention phase.
Reversal of cardiometabolic abnormalities is defined as:
At the 14th day of dietary intervention phase, at least one of the following indicators changed from abnormal at baseline to normal: overweight, obesity, prediabetes, hyperlipidemia and elevated blood pressure.
(The reversal of overweight or obesity is defined according to reference[1, 2]: For subject with general obesity at baseline: weight loss of 1.5 kg after intervention; For subject with central obesity at baseline: waist circumference reduction of 1.5 cm after intervention.)
Measured: From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase.
Secondary outcomes (13)
Change in insulin
Serum from fasting blood sample is used for measurement of insulin.
Measured: From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase.
Change in insulin-like growth factor-1
Fasting blood sample for measurement of insulin-like growth factor-1.
Measured: From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase.
Change in mean blood glucose
Measured by a blood glucose monitor for 24-hour glucose monitoring during the 14-day intervention phase.
Measured: From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase.
Change in gut microbial compositions
Stool sample of subject is used for measurement of gut microbial compositions.
Measured: From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase.
Change in body weight
Body weight is measured according to the Physical Fitness and Health Surveillance of Chinese School Students by trained, certified study staff. It is measured to the nearest 0.1 kg.
Measured: From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase.
Change in body weight
Body weight is measured by subject and reported by electronic questionnaire. It is measured to the nearest 0.1 kg.
Measured: From the baseline (the first day of the intervention phase) to the 14th day of the self-maintenance phase.
Change in waist circumference
Waist circumference is measured to the nearest 0.1 cm using a constant tension tape around the waist at 1 cm below the navel as the subject exhaled. It is calculated as the average value of two measurements.
Measured: From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase.
Change in waist circumference
Waist circumference is measured by subject and reported by electronic questionnaire. It is measured to the nearest 0.1 cm using a constant tension tape around the waist at 1 cm below the navel as the subject exhaled. It is calculated as the average value of two measurements.
Measured: From the baseline (the first day of the intervention phase) to the 14th day of the self-maintenance phase.
Dietary energy intake
Daily dietary energy intake (kcals/day) is calculated by researchers using food weighing photos of the subject.
Measured: From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase.
Self-reported dietary adherence
Adherence to diet will be assessed with a electronic questionnaire in the self-maintenance phase.
Measured: At the 14th day of the self-maintenance phase.
Change in monocyte chemoattractant protein-1 (MCP-1)
MCP-1 will be measured by enzyme-linked immunosorbent assays (R\&D Systems, Inc. USA), using fasting serum samples at baseline and 14 days after intervention.
Measured: From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase.
Change in free fatty acid (FFA)
FFA will be measured by enzyme-linked immunosorbent assays (R\&D Systems, Inc. USA), using fasting serum samples at baseline and 14 days after intervention.
Measured: From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase.
Change in fibroblast growth factor 21 (FGF-21)
FGF-21 will be measured by enzyme-linked immunosorbent assays (R\&D Systems, Inc. USA), using fasting serum samples at baseline and 14 days after intervention.
Measured: From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start12 Jul 2018
- Primary completion16 Nov 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weili Yan, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04011995
- Sponsor's protocol ID
- ICR_2019_2.0
- Status last verified
- Mar 2022
- First submitted
- 4 Jul 2019
- Last updated
- 22 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Harvie MN, Pegington M, Mattson MP, Frystyk J, Dillon B, Evans G, Cuzick J, Jebb SA, Martin B, Cutler RG, Son TG, Maudsley S, Carlson OD, Egan JM, Flyvbjerg A, Howell A. The effects of intermittent or continuous energy restriction on weight loss and metabolic disease risk markers: a randomized trial in young overweight women. Int J Obes (Lond). 2011 May;35(5):714-27. doi: 10.1038/ijo.2010.171. Epub 2010 Oct 5.
PubMed 20921964Arnason TG, Bowen MW, Mansell KD. Effects of intermittent fasting on health markers in those with type 2 diabetes: A pilot study. World J Diabetes. 2017 Apr 15;8(4):154-164. doi: 10.4239/wjd.v8.i4.154.
PubMed 28465792Dou Y, Jiang Y, Chen X, Zhang Y, Wang Y, Chen H, He W, Yan W. Intermittent dietary carbohydrate restriction versus calorie restriction and cardiometabolic profiles: A randomized trial. Obesity (Silver Spring). 2023 Sep;31(9):2260-2271. doi: 10.1002/oby.23855. Epub 2023 Aug 7.
PubMed 37545298
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intermittent Caloric Restriction in Youth With Cardiometabolic Risk: a Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT04011995
- Acronym / sponsor ID
- ICR_2019_2.0
- Conditions
- Overweight, Obesity, Cardiometabolic Risk
- Keywords
- Intermittent caloric restriction, Children, Youth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 12 Jul 2018 (actual)
- Primary completion
- 16 Nov 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 9 Jul 2019 (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 is a randomized controlled pilot study to evaluate the effects of intermittent caloric restriction compared with low carbohydrate diet in youth with cardiometabolic risk.
Detailed description
The National China Health and Nutrition Survey revealed that 42% of overweight children had at least one cardiovascular metabolic risk, such as hyperglycaemia, dyslipidemia or hypertension. Non-pharmaceutical life style modifications are the recommended intervention to these subjects, including caloric restriction and increased physical activity. However, the problems of poor compliance and metabolic adaptation are well known. Evidences from a number studies in rodent models and human indicated that intermittent caloric restriction (ICR) may stimulate series reactions in human body, including improvement of insulin sensitivity, blood pressure, oxidative stress and inflammation, and may be easier to follow. Evidence from larger human studies is strongly encouraged, while the effects, safety and adherence in chidren and youth need to be studied.
This study is a randomized controlled trial of intermittent caloric restriction versus low carbohydrate diet in youth with cardiometabolic risk over one month period. The intervention is based on the 5:2 diet, which involves caloric restriction for 2 days (consecutive or nonconsecutive, 600kcal/d for male and 500kcal/d for female) per week and unrestricted eating during the other 5 days of the week. For control group, the subjects receive 7 days (consecutive or nonconsecutive) of low carbohydrate diet intervention during the 14-day intervention period,. Carbohydrate intake of low-carbohydrate diet should be controlled as ≤ 50g per day. Total trial duration is one month consisting of a 14-day intervention phase and a 14-day self-maintenance phase. During the maintenance phase, two follow-up electronic questionnaires were conducted.
The study aim to explore effects of the dietary interventions on cardiometabolic markers, inflammatory reaction, oxidative stress and gut microbiome in youth with cardiometabolic risk.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent caloric restriction | Experimental | Behavioral: Intermittent caloric restriction, Behavioral: Health education on reducing the cardiometabolic risk |
| Low carbohydrate diet | Active comparator | Behavioral: Low carbohydrate diet, Behavioral: Health education on reducing the cardiometabolic risk |
Who may qualify
- Ages
- 9 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (26 listed)
- Overweight or obesity (central obesity or general obesity)
- Prediabetes: impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT)
- Dyslipidemia
- Elevated blood pressure
- Overweight or obesity
Key exclusion criteria (3 listed)
- Diagnosis of severe diseases such as cardiac insufficiency, severe malnutrition or immunodeficiency.
- History of bariatric surgery.
- Use of antiobesity drugs or supplements.
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 |
|---|---|---|
| Intermittent caloric restrictionAlso: Intermittent fastingThe intervention is based on the 5:2 diet, which involves caloric restriction for 2 days (consecutive or nonconsecutive, 600kcal/d for male and 500kcal/d for female) per week and unrestricted eating during the other 5 days of the week. Total trial duration is one month consisting of a 14-day intervention phase and a 14-day self-maintenance phase. During the maintenance phase, two follow-up electronic questionnaires were conducted. | Behavioural | Intermittent caloric restriction |
| Low carbohydrate dietDuring the 14-day intervention period, the subjects receive 7 days (consecutive or nonconsecutive) of low carbohydrate diet intervention. Carbohydrate intake of low-carbohydrate diet should be controlled as ≤ 50g per day. Total trial duration is one month consisting of a 14-day intervention phase and a 14-day self-maintenance phase. During the maintenance phase, two follow-up electronic questionnaires were conducted. | Behavioural | Low carbohydrate diet |
| Health education on reducing the cardiometabolic riskHealth education is conducted once a week during 14-day dietary intervention for all subjects. Health education including the understanding of cardiovascular disease, how to determine the cardiometabolic risk level, and the lifestyle intervention as caloric restriction and increased physical activity to promote health. | Behavioural | Intermittent caloric restriction, Low carbohydrate diet |
Primary outcome
Reversal of cardiometabolic abnormalities
Time frame: From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase.
The primary outcome is a composite outcome that will be measured by combining multiple reverse outcomes of the following cardiometabolic abnormalities: (1) overweight or obesity, (2) prediabetes, (3) hyperlipidemia and (4) elevated blood pressure. It is defined as occurring if any cardiometabolic abnormality has a reversal outcome at the 14th day of dietary intervention phase. Reversal of cardiometabolic abnormalities is defined as: At the 14th day of dietary intervention phase, at least one of the following indicators changed from abnormal at baseline to normal: overweight, obesity, prediabetes, hyperlipidemia and elevated blood pressure. (The reversal of overweight or obesity is defined according to reference[1, 2]: For subject with general obesity at baseline: weight loss of 1.5 kg after intervention; For subject with central obesity at baseline: waist circumference reduction of 1.5 cm after intervention.)
13 secondary outcomes
Change in insulin
Time frame: From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase.
Change in insulin-like growth factor-1
Time frame: From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase.
Change in mean blood glucose
Time frame: From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase.
Change in gut microbial compositions
Time frame: From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase.
Change in body weight
Time frame: From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase.
Change in body weight
Time frame: From the baseline (the first day of the intervention phase) to the 14th day of the self-maintenance phase.
Change in waist circumference
Time frame: From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase.
Change in waist circumference
Time frame: From the baseline (the first day of the intervention phase) to the 14th day of the self-maintenance phase.
Dietary energy intake
Time frame: From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase.
Self-reported dietary adherence
Time frame: At the 14th day of the self-maintenance phase.
Change in monocyte chemoattractant protein-1 (MCP-1)
Time frame: From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase.
Change in free fatty acid (FFA)
Time frame: From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase.
Change in fibroblast growth factor 21 (FGF-21)
Time frame: From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase.
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 22 Mar 2022.
- Background: PubMed 20921964Harvie MN, Pegington M, Mattson MP, Frystyk J, Dillon B, Evans G, Cuzick J, Jebb SA, Martin B, Cutler RG, Son TG, Maudsley S, Carlson OD, Egan JM, Flyvbjerg A, Howell A. The effects of intermittent or continuous energy restriction on weight loss and metabolic disease risk markers: a randomized trial in young overweight women. Int J Obes (Lond). 2011 May;35(5):714-27. doi: 10.1038/ijo.2010.171. Epub 2010 Oct 5.
- Background: PubMed 28465792Arnason TG, Bowen MW, Mansell KD. Effects of intermittent fasting on health markers in those with type 2 diabetes: A pilot study. World J Diabetes. 2017 Apr 15;8(4):154-164. doi: 10.4239/wjd.v8.i4.154.
- Derived from this study: PubMed 37545298Dou Y, Jiang Y, Chen X, Zhang Y, Wang Y, Chen H, He W, Yan W. Intermittent dietary carbohydrate restriction versus calorie restriction and cardiometabolic profiles: A randomized trial. Obesity (Silver Spring). 2023 Sep;31(9):2260-2271. doi: 10.1002/oby.23855. Epub 2023 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent caloric restriction, Low carbohydrate diet and Health education on reducing the cardiometabolic risk in people with Overweight and Obesity, run by Children's Hospital of Fudan University at 1 site in China.
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 26 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 22 Mar 2022. 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 China. 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?
Reversal of cardiometabolic abnormalities (time frame: From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase.). 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 NCT04011995, which also lists 3 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 22 Mar 2022.