Type 2 DiabetesNCT05439226
Liver Fat as a Dietary Target of the Chinese Medical Nutrition Therapy (CMNT) Diet for Treating Type 2 Diabetes With Nonalcoholic Fatty Liver Disease
A study testing CMNT diet in people with Type 2 Diabetes, run by State Key Laboratory of Subhealth Intervention Technology at 3 sites in China.
Trial summary
Type 2 diabetes (T2D) represents a serious public health problem. Patients with T2D and non-alcoholic fatty liver disease(NAFLD) demonstrate a poor metabolic profile and increase mortality compared with patients with only NAFLD or T2D. Nutritional intervention is the most basic treatment for T2D. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- CMNT diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesChina
- Study dates
- 5 Jul 2022to 5 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with type 2 diabetes and NAFLD
- Age between 18 and 75 years
- BMI between 18.0 and 35.0 kg/m2
- Weight stable for at least 3 months prior to the study (gain or loss < 4 kg)
- Stable treatment for at least 3 months with 1-3 oral antidiabetic medications (with or without insulin therapy), or not yet received antidiabetic medication prior to the beginning of the study
- Able to give written informed consent
Who cannot join
- Self-reported a food allergy
- Alcohol abuse in the last 3 months (alcohol intake greater than 20 g per day for women; Alcohol intake for men greater than 40 g per day)
- Other liver diseases such as chronic hepatitis B and C, autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis, nodular regenerative hyperplasia and focal nodular hyperplasia
- Scheduled to be hospitalized for any surgical treatment during screening
- Pregnant or planning of pregnancy during the study
- Inability, physically or mentally, to adhere the procedures required by the study protocol
Show all 11Show fewer
- Level 3 hypoglycemic events (at least 3 times) occurring within the 90 days prior to screening
- Hospitalization or emergency department visit for hyperglycemia, diabetic ketoacidosis, lactic acidosis, hyperosmolar nonketotic coma, or diabetes
- History of cancer within the past 5 years
- Acute coronary or cerebrovascular event in the past 90 days, or heart failure
- Hemorrhagic or ischemic stroke within the last 6 months
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Hunan Shanshui physical examination center
Changsha, Hunan
Wu Luo, luowubio@163.com
- Recruiting
Jinheyuan Outpatient Department, National Sub-health Intervention Technology Achievement Application Center
Changsha, Hunan
Xiao Yang, 31884210@qq.com
- Recruiting
Physical Examination Center of Gezhouba central hospital of Sinopharm
Yichang, Hubei
Jian Li, 18942546818@163.com
About this study
Type 2 diabetes (T2D) represents a serious public health problem. Patients with T2D and non-alcoholic fatty liver disease(NAFLD) demonstrate a poor metabolic profile and increase mortality compared with patients with only NAFLD or T2D. Nutritional intervention is the most basic treatment for T2D. Previous study showed that a Chinese medical nutrition therapy (CMNT) diet, which intermittent use of low-calorie medicinal food, has a glucose-lowering effect in T2D. This study aims to investigate the effect of a Chinese medical nutrition therapy (CMNT) diet accompanied by intermittent energy restriction on reducing liver fat and glycated hemoglobin (HbA1c) in patients with T2D and NAFLD.
Read the detailed description
Diet composition of CMNT is a multicomponent Chinese medicinal food, which mainly enriched with whole grains and edible medicine and food homologous (MFH) plants such as Rhizoma Dioscoreae, Momordica Grosvenori, Folium Mori, Radix Puerariae, Fructus lycii, Poria cocos that meets the requirements of a food for special medical purpose. The CMNT group was instructed to consumed the provided CMNT diet consisting of 6 cycles of 5 consecutive days followed by 10 days of ad libitum food consumption. Participants received a 917 kcal/day preprepared human CMNT diet (44.75% carbohydrate, 9.1% protein and 46.15% fat) for 5 consecutive days per cycle. CMNT diet is composed of four ready-to-consume prepared foods including composite nutritional rice, solids beverages, meal replacement biscuit and fruit and vegetable gruel mainly from wholegrains and traditional Chinese medicinal food plants. The intervention lasted for 3 months (6 cycles) and follow-up measurements will be performed in all subjects after 3-months from end of the intervention. The glucose-lowering medication use of participants strictly implemented by their physician according to the diabetes medications management protocol. Treatment-as-usual control group continued to be given standard medication and dietary advice by their physician followed guidelines for the prevention and control of T2D in China.
- Conditions
- Type 2 Diabetes
- Being tested
- CMNT diet
- Keywords
- Type 2 Diabetes with NAFLD, CMNT diet
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMNT dietOther
Hypocaloric CMNT diet plan: A diet plan with intermittent use of enriched traditional-Chinese-medicinal-foods CMNT diet
| Study group | Role | What they receive |
|---|---|---|
| CMNT diet | Experimental | The CMNT group was instructed to consumed the provided CMNT diet consisting of 6 cycles of 5 consecutive days followed by 10 days of ad libitum food consumption. Participants received a 917 kcal/day preprepared human CMNT diet (44.75% carbohydrate, 9.1% protein and 46.15% fat) for 5 consecutive days per cycle Receives: Other: CMNT diet |
| Usual Care | No intervention | Dietary recommendations based on the Guideline for the prevention and treatment of type 2 diabetes mellitus in China (2020 edition) as the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Controlled attenuation parameter (CAP) value by transient elastography
The CAP score, which be measured by FibroScan, will be used to quantify and detect liver fat. CAP < 238 dB/m indicated no hepatic steatosis, 238 ≤ CAP ≤ 259 dB/m denoted mild steatosis, 260 ≤ CAP ≤291 dB/m indicated moderate steatosis, and CAP > 291 dB/m denoted severe steatosis.
Measured: 3, 6, 12, 24 months
HbA1C
Blood test to measure glucose control
Measured: 3, 6, 12, 24 months
Secondary outcomes (24)
Fatty liver index (FLI)
FLI will also be applied to quantify the degree of steatosis of patients with type 2 diabetes and NAFLD. FLI values < 30 rule out liver steatosis, whereas FLI ≥ 60 confirmed NAFLD with a specificity of 61%.
Measured: 3, 6, 12, 24 months
Hepatic steatosis index (HSI)
HSI will also be applied to quantify the degree of steatosis of patients with type 2 diabetes and NAFLD. HSI values < 30 excludes NAFLD with a sensitivity of 93.1%, while values > 36 detected NAFLD with a specificity of 92.4%.
Measured: 3, 6, 12, 24 months
Liver stiffness measurement (LSM) value by transient elastography
Liver fibrosis will be assessed by using a non-invasive vibration-controlled transient elastography to estimate LSM. A median LSM ≥ 8.2 kPa was considered indicative of significant fibrosis (≥ F2), whereas LSM ≥ 9.7 kPa was considered indicative of advanced (≥ F3) fibrosis, whereas LSM ≥ 13.6 kPa was considered indicative of cirrhosis (F4).
Measured: 3, 6, 12, 24 months
Fibrosis-4 index (FIB-4)
The FIB-4 index, a non-invasive measurement, will be used to evaluate the degree of liver fibrosis. The FIB-4 index <1.45 had a negative predictive value of 94.7% to exclude progressive fibrosis, whereas FIB-4 index >3.25 was considered advanced fibrosis or cirrhosis.
Measured: 3, 6, 12, 24 months
NAFLD fibrosis score (NFS)
Degree of liver fibrosis will also be assessed by NFS.The probability of advanced liver fibrosis was classified into three groups: high NFS (NFS > 0.676), intermediate NFS (NFS: -1.455 to 0.676, or 0.120 to 0.676 if age > 65), or low NFS (NFS < -1.455, or < 0.120 if age > 65) .
Measured: 3, 6, 12, 24 months
Liver function test
γ-glutamyl transferase (γ-GGT), alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) and ect will be assessed.
Measured: 3, 6, 12, 24 months
Blood glucose
Fasting plasma glucose (FPG) and postprandial 2-hour plasma glucose (2 h-PG)
Measured: 3, 6, 12, 24 months
Blood lipid
triglyceride, total cholesterol, low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein-cholesterol (HDL-C)
Measured: 3, 6, 12, 24 months
Insulin
Glucose homeostasis
Measured: 3, 6, 12, 24 months
HOMA-IR
Fasting glucose times fasting insulin divided by 22.5
Measured: 3, 6, 12, 24 months
IGF-1
Glucose homeostasis
Measured: 3, 6, 12, 24 months
Body mass index
Body mass in kilograms divided by height in meters squared.
Measured: 3, 6, 12, 24 months
waist-to-hip ratio
Waist circumference in centimeter divided by height in centimeter.
Measured: 3, 6, 12, 24 months
Blood pressure
Systolic blood pressure and diastolic blood pressure.
Measured: 3, 6, 12, 24 months
Energy intake
3-day diet record and Food Frequency Questionnaire
Measured: 3, 6, 12, 24 months
Macronutrient intake
3-day diet record and Food Frequency Questionnaire
Measured: 3, 6, 12, 24 months
Sleep quality
Pittsburgh Sleep Quality Index Questionnaire
Measured: 3, 6, 12, 24 months
Physical activity
International Physical Activity Questionnaire
Measured: 3, 6, 12, 24 months
Self-reported depressive symptoms
Patient Health Questionnaire 9
Measured: 3, 6, 12, 24 months
Anxiety symptoms
Generalized Anxiety Disorder scale
Measured: 3, 6, 12, 24 months
Social support
Social Support Rate Scale
Measured: 3, 6, 12, 24 months
Reduction in glucose-lowering medication
Reduction in total dose of glucose-lowering medications
Measured: 3, 6, 12, 24 months
Fecal microbiota profile
Fecal samples will be collected and will be sequenced.
Measured: 3, 6, 12, 24 months
Metabolomics
Blood, fecal and urine samples will be collected and metabolites will be analyzed through a metabolomics approach.
Measured: 3, 6, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start5 Jul 2022
- Primary completion5 May 2026 (estimated)
- Study completion5 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State Key Laboratory of Subhealth Intervention Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439226
- Sponsor's protocol ID
- Version 2.0
- Status last verified
- Jul 2025
- First submitted
- 21 Jun 2022
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Luo W, Xiao Z, Yang X, Wu R, Li J, Yu Z, Guo S, Nie B, Liu D. Liver fat as a dietary target by Chinese Medical Nutrition Therapy (CMNT) diet for treating type 2 diabetes with non-alcoholic fatty liver disease: study protocol for a randomised controlled trial. BMJ Open. 2024 Apr 29;14(4):e081263. doi: 10.1136/bmjopen-2023-081263.
PubMed 38684277
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver Fat as a Dietary Target of the Chinese Medical Nutrition Therapy (CMNT) Diet for Treating Type 2 Diabetes With Nonalcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT05439226
- Acronym / sponsor ID
- Version 2.0
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 Diabetes with NAFLD, CMNT diet
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- State Key Laboratory of Subhealth Intervention TechnologyUniversity, hospital or other
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- 5 May 2026 (estimated)
- Study completion
- 5 Jun 2026 (estimated)
- First posted
- 30 Jun 2022 (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.
Type 2 diabetes (T2D) represents a serious public health problem. Patients with T2D and non-alcoholic fatty liver disease(NAFLD) demonstrate a poor metabolic profile and increase mortality compared with patients with only NAFLD or T2D. Nutritional intervention is the most basic treatment for T2D. Previous study showed that a Chinese medical nutrition therapy (CMNT) diet, which intermittent use of low-calorie medicinal food, has a glucose-lowering effect in T2D. This study aims to investigate the effect of a Chinese medical nutrition therapy (CMNT) diet accompanied by intermittent energy restriction on reducing liver fat and glycated hemoglobin (HbA1c) in patients with T2D and NAFLD.
Detailed description
Diet composition of CMNT is a multicomponent Chinese medicinal food, which mainly enriched with whole grains and edible medicine and food homologous (MFH) plants such as Rhizoma Dioscoreae, Momordica Grosvenori, Folium Mori, Radix Puerariae, Fructus lycii, Poria cocos that meets the requirements of a food for special medical purpose. The CMNT group was instructed to consumed the provided CMNT diet consisting of 6 cycles of 5 consecutive days followed by 10 days of ad libitum food consumption. Participants received a 917 kcal/day preprepared human CMNT diet (44.75% carbohydrate, 9.1% protein and 46.15% fat) for 5 consecutive days per cycle. CMNT diet is composed of four ready-to-consume prepared foods including composite nutritional rice, solids beverages, meal replacement biscuit and fruit and vegetable gruel mainly from wholegrains and traditional Chinese medicinal food plants. The intervention lasted for 3 months (6 cycles) and follow-up measurements will be performed in all subjects after 3-months from end of the intervention. The glucose-lowering medication use of participants strictly implemented by their physician according to the diabetes medications management protocol. Treatment-as-usual control group continued to be given standard medication and dietary advice by their physician followed guidelines for the prevention and control of T2D in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CMNT diet | Experimental | Other: CMNT dietThe CMNT group was instructed to consumed the provided CMNT diet consisting of 6 cycles of 5 consecutive days followed by 10 days of ad libitum food consumption. Participants received a 917 kcal/day preprepared human CMNT diet (44.75% carbohydrate, 9.1% protein and 46.15% fat) for 5 consecutive days per cycle |
| Usual Care | No intervention | –Dietary recommendations based on the Guideline for the prevention and treatment of type 2 diabetes mellitus in China (2020 edition) as the control group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients diagnosed with type 2 diabetes and NAFLD
- Age between 18 and 75 years
- BMI between 18.0 and 35.0 kg/m2
- Weight stable for at least 3 months prior to the study (gain or loss < 4 kg)
- Stable treatment for at least 3 months with 1-3 oral antidiabetic medications (with or without insulin therapy), or not yet received antidiabetic medication prior to the beginning of the study
Key exclusion criteria (11 listed)
- Self-reported a food allergy
- Alcohol abuse in the last 3 months (alcohol intake greater than 20 g per day for women; Alcohol intake for men greater than 40 g per day)
- Other liver diseases such as chronic hepatitis B and C, autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis, nodular regenerative hyperplasia and focal nodular hyperplasia
- Scheduled to be hospitalized for any surgical treatment during screening
- Pregnant or planning of pregnancy during the study
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 |
|---|---|---|
| CMNT dietHypocaloric CMNT diet plan: A diet plan with intermittent use of enriched traditional-Chinese-medicinal-foods CMNT diet | Other | CMNT diet |
Primary outcome
Controlled attenuation parameter (CAP) value by transient elastography
Time frame: 3, 6, 12, 24 months
The CAP score, which be measured by FibroScan, will be used to quantify and detect liver fat. CAP < 238 dB/m indicated no hepatic steatosis, 238 ≤ CAP ≤ 259 dB/m denoted mild steatosis, 260 ≤ CAP ≤291 dB/m indicated moderate steatosis, and CAP > 291 dB/m denoted severe steatosis.
HbA1C
Time frame: 3, 6, 12, 24 months
Blood test to measure glucose control
24 secondary outcomes
Fatty liver index (FLI)
Time frame: 3, 6, 12, 24 months
Hepatic steatosis index (HSI)
Time frame: 3, 6, 12, 24 months
Liver stiffness measurement (LSM) value by transient elastography
Time frame: 3, 6, 12, 24 months
Fibrosis-4 index (FIB-4)
Time frame: 3, 6, 12, 24 months
NAFLD fibrosis score (NFS)
Time frame: 3, 6, 12, 24 months
Liver function test
Time frame: 3, 6, 12, 24 months
Blood glucose
Time frame: 3, 6, 12, 24 months
Blood lipid
Time frame: 3, 6, 12, 24 months
Insulin
Time frame: 3, 6, 12, 24 months
HOMA-IR
Time frame: 3, 6, 12, 24 months
IGF-1
Time frame: 3, 6, 12, 24 months
Body mass index
Time frame: 3, 6, 12, 24 months
waist-to-hip ratio
Time frame: 3, 6, 12, 24 months
Blood pressure
Time frame: 3, 6, 12, 24 months
Energy intake
Time frame: 3, 6, 12, 24 months
Macronutrient intake
Time frame: 3, 6, 12, 24 months
Sleep quality
Time frame: 3, 6, 12, 24 months
Physical activity
Time frame: 3, 6, 12, 24 months
Self-reported depressive symptoms
Time frame: 3, 6, 12, 24 months
Anxiety symptoms
Time frame: 3, 6, 12, 24 months
Social support
Time frame: 3, 6, 12, 24 months
Reduction in glucose-lowering medication
Time frame: 3, 6, 12, 24 months
Fecal microbiota profile
Time frame: 3, 6, 12, 24 months
Metabolomics
Time frame: 3, 6, 12, 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Derived from this study: PubMed 38684277Luo W, Xiao Z, Yang X, Wu R, Li J, Yu Z, Guo S, Nie B, Liu D. Liver fat as a dietary target by Chinese Medical Nutrition Therapy (CMNT) diet for treating type 2 diabetes with non-alcoholic fatty liver disease: study protocol for a randomised controlled trial. BMJ Open. 2024 Apr 29;14(4):e081263. doi: 10.1136/bmjopen-2023-081263.
- Individual participant dataSharing planned: Yes
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CMNT diet in people with Type 2 Diabetes, run by State Key Laboratory of Subhealth Intervention Technology at 3 sites 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 6 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luo wu (13687333270, luowubio@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Controlled attenuation parameter (CAP) value by transient elastography (time frame: 3, 6, 12, 24 months). 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 NCT05439226, which also lists 1 linked publication.
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 25 Jul 2025.