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Metabolic SyndromeNCT04475822

Explore the Effect of Diet Intervention on Lipid Metabolism and Body Mass Index Among the Patients With Metabolic Syndrome

A study testing Intermittent fasting, Low carb diet and Low carbon diet and intermittent fasting group in people with Metabolic Syndrome, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The prevalence of metabolic syndrome (MetS) is increasing all over the world, which is largely related to the increasing obesity population and the current inactive lifestyle of human beings. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Metabolic Syndrome
What is being tested?
Intermittent fasting, Low carb diet and Low carbon diet and intermittent fasting group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
169 participants
Where
1 siteChina
Study dates
12 Jul 2020to 30 Jun 2022
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosed with metabolic syndrome (i.e., more than 3 abnormal findings out of 5):
  • Waist circumference ≥ 90 cm (men) or ≥ 80 cm (women).
  • Elevated TG (use of medications for elevated TG is an alternate indicator) ≥ 150 mg/dL (1.7 mmol/L).
  • Reduced HDL-c (use of medications for reduced HDL-c is an alternate indicator) < 40 mg/dL (1.0 mmol/L) in males < 50 mg/dL (1.3 mmol/L) in females.
  • Elevated blood pressure (use of hypoglycemic medications is an alternate indicator). SBP ≥ 130 and/or DBP ≥ 85 mmHg.
  • Elevated FBG (used of hypoglycemic medications is an alternate indicator) ≥ 100 mg/dL (5.6 mmol/L).
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  • Age from 18 to 65 years.
  • Stable weight (change ≤ 10% current body weight) for 3 months prior to the study.
  • If participates were on hypoglycemic medications, hypotensive medications, lipid-lowering medications and cardiovascular medications, dose adjustment was not permitted during the 3-month intervention.

Who cannot join

  • Pregnant or breast-feeding.
  • Night shift workers.
  • History of major diseases or related diseases, such as inflammatory disease, rheumatologic disease, adrenal disease, malignancy, type 1 diabetes, cirrhosis, chronic kidney disease, acquired immunodeficiency syndrome, eating disorder, uncontrolled psychiatric disorder and major adverse cardiovascular event.
  • Current participate in other weight-management program, current on a prescribed diet for special disease or current on any drugs that effect appetite.
  • History of weight-loss surgery.

Trial locations and contacts

1 site in 1 country.

China1 site

  • First Affiliated Hospital of Xi an Jiaotong University

    Xi'an, Shaanxi, 710061

Other trials in China

About this study

Official title: An Intervention Study of Intermittent Fasting and Low Carbon Diet in Patients With Metabolic Syndrome

The prevalence of metabolic syndrome (MetS) is increasing all over the world, which is largely related to the increasing obesity population and the current inactive lifestyle of human beings. It is a common problem facing public health and clinical practice.Metabolic syndrome is an accumulation of biologically metabolic risk factors related to cardiovascular disease and diabetes, including glucose metabolism disorders, hypertension, dyslipidemia, and obesity (especially central obesity).Researchers believe that the common pathological basis of these manifestations is insulin resistance, which is generally considered to be a reduction in the biological effects of insulin compared with the normal biological effects of expected biological phenomena.Nowadays, there are more and more studies on insulin resistance in the world. We have known that age, poor living and eating habits, high blood fat, high blood sugar and stress all lead to insulin resistance.

The researchers hope to reduce weight, reduce body fat rate, improve body fat distribution and insulin resistance, reverse abnormal metabolic indicators, and ultimately reduce the incidence of chronic diseases in patients with metabolic syndrome through the intervention of lifestyle and diet habits in the early stage of the disease.

Being tested
Intermittent fasting, Low carb diet, Low carbon diet and intermittent fasting group
Medical subject headings
Metabolic Syndrome

What participants receive

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

  • Intermittent fastingBehavioural

    Also called Low carb diet, Low carbon diet and intermittent fasting group

    Intermittent fasting group:During the three-month intervention period, participants were allowed to eat for eight consecutive hours and fast for 16 hours a day.The eating time can be freely chosen in the following two periods: 8:00 -- 16:00;12:00 -- 20:00.No specific restriction shall be made on the type and quantity of food.

  • Low carb dietBehavioural

    Low carb diet:The daily carbohydrate intake of participants in this group was limited to 130g/ D, and the recommended diet was formulated according to the standard and combined with the local eating habits in Xi 'an, and dietary habit education was conducted. Participants could eat according to the recommended diet.

  • Low carbon diet and intermittent fasting groupBehavioural

    Low carbon diet and intermittent fasting group:Participants fasted for 16 hours a day and ate for eight consecutive hours on the same diet as the low-carb group.

Study groups in NCT04475822
Study groupRoleWhat they receive
Intermittent fastingExperimentalDuring the three-month intervention period, participants were allowed to eat for eight consecutive hours and fast for 16 hours a day.The eating time can be freely chosen in the following two periods: 8:00 -- 16:00;12:00 -- 20:00.No specific restriction shall be made on the type and quantity of food.
Receives: Behavioral: Intermittent fasting
Low carb dietExperimentalAccording to the definition of low carbon diet given by R. D. Feinman et al. (Nutrition, 2015), the daily carbohydrate intake of participants in this group was limited to 130g/ D, and the recommended diet was formulated according to the standard and combined with the local eating habits in Xi 'an, and dietary habit education was conducted. Participants could eat according to the recommended diet.
Receives: Behavioral: Low carb diet
Low carbon diet and intermittent fasting groupExperimentalParticipants fasted for 16 hours a day and ate for eight consecutive hours on the same diet as the low-carb group.
Receives: Behavioral: Low carbon diet and intermittent fasting group

What is being measured

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

  1. weight

    kg

    Measured: Three months after the intervention

  2. body fat

    Measured: Three months after the intervention

Secondary outcomes (4)

  1. blood pressure

    mmHg

    Measured: Three months after the intervention

  2. blood glucose

    mmol/L

    Measured: Three months after the intervention

  3. blood lipid

    mmol/L

    Measured: Three months after the intervention

  4. uric acid

    µmol/L

    Measured: Three months after the intervention

Timeline

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

  1. First posted17 Jul 2020
  2. Study start12 Jul 2020
  3. Primary completion31 Jan 2021
  4. Study completion30 Jun 2022

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
169 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04475822
Sponsor's protocol ID
XJTU1AF2020LSK-003
Status last verified
Jul 2022
First submitted
15 Jul 2020
Last updated
11 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zheng Y, Wang J, Liu M, Zhou X, Lin X, Liang Q, Yang J, Zhang M, Chen Z, Li M, Wang Y, Sui J, Qiang W, Guo H, Shi B, He M. Time-restricted eating with or without a low-carbohydrate diet improved myocardial status and thyroid function in individuals with metabolic syndrome: secondary analysis of a randomized clinical trial. BMC Med. 2024 Sep 4;22(1):362. doi: 10.1186/s12916-024-03595-6.

    PubMed 39227921

  • Zheng Y, Wang X, Wang J, Yang J, Wang T, Li Q, Zhu W, Wang Y, Sui J, Qiang W, Guo H, Wang Y, Shi B, He M. Effects of time-restricted eating and low-carbohydrate diet on psychosocial health and appetite in individuals with metabolic syndrome: A secondary analysis of a randomized controlled trial. Clin Nutr. 2024 Oct;43(10):2316-2324. doi: 10.1016/j.clnu.2024.08.029. Epub 2024 Aug 30.

    PubMed 39226719

  • He M, Wang J, Liang Q, Li M, Guo H, Wang Y, Deji C, Sui J, Wang YW, Liu Y, Zheng Y, Qian B, Chen H, Ma M, Su S, Geng H, Zhou WX, Guo X, Zhu WZ, Zhang M, Chen Z, Rensen PCN, Hui CC, Wang Y, Shi B. Time-restricted eating with or without low-carbohydrate diet reduces visceral fat and improves metabolic syndrome: A randomized trial. Cell Rep Med. 2022 Oct 18;3(10):100777. doi: 10.1016/j.xcrm.2022.100777. Epub 2022 Oct 10.

    PubMed 36220069

Questions about this trial

What is this clinical trial studying?

A study testing Intermittent fasting, Low carb diet and Low carbon diet and intermittent fasting group in people with Metabolic Syndrome, run by First Affiliated Hospital Xi'an Jiaotong 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 9 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 11 Jul 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?

weight (time frame: Three months after the intervention). The study lists 2 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 NCT04475822, 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 11 Jul 2022.

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