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Effect and mechanism of traditional Chinese medicine nutrition therapy in improving type 2 diabetes mellitus complicated with cognitive dysfunction: study protocol for a randomised controlled trial

Registration number：

ITMCTR2024000679

Date of Last Refreshed on：

2024-11-08

Date of Registration：

2024-11-08

Registration Status：

Prospective registration

Public title：

Effect and mechanism of traditional Chinese medicine nutrition therapy in improving type 2 diabetes mellitus complicated with cognitive dysfunction: study protocol for a randomised controlled trial

English Acronym：

Scientific title：

Effect and mechanism of traditional Chinese medicine nutrition therapy in improving type 2 diabetes mellitus complicated with cognitive dysfunction

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

He Hailong

Study leader：

He Hailong

Applicant telephone：

+86 185 7335 2323

Study leader's telephone：

+86 185 7335 2323

Applicant Fax：

Study leader's fax：

Applicant E-mail：

2583592837@qq.com

Study leader's E-mail：

2583592837@qq.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No. 69 Chuanshan Avenue Shigu District Hengyang City Hunan Province

Study leader's address：

No. 69 Chuanshan Avenue Shigu District Hengyang City Hunan Province

Applicant postcode：

Study leader's postcode：

Applicant's institution：

University of South China; The First Affiliated Hospital of University of South China

Approved by ethic committee：

Approved No. of ethic committee：

2023NHHL064

Approved file of Ethical Committee：

View

Name of the ethic committee：

University of South China Medical Ethics Committee

Date of approved by ethic committee：

2023/12/28 0:00:00

Contact Name of the ethic committee：

Liu Liangzhuan

Contact Address of the ethic committee：

No. 28 Changsheng West Road Hongxiang Street Chuanxiang District Hengyang City Hunan Province

Contact phone of the ethic committee：

+86 734 828 2726

Contact email of the ethic committee：

2583592837@qq.com

Primary sponsor：

University of South China

Primary sponsor's address：

No. 28 Changsheng West Road Hongxiang Street Chuanxiang District Hengyang City Hunan Province

Secondary sponsor：

Country：

China

Province：

Hunan Province

City：

Hengyang City

Institution
hospital：

University of South China

Address：

No. 28 Changsheng West Road Hongxiang Street Chuanxiang District Hengyang City Hunan Province

Source(s) of funding：

self-financing

Target disease：

type 2 diabetes mellitus with cognitive impairment

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

In the elderly in Chinese community Chinese medicine nutrition therapy (CMNT) was used as intervention method cognitive function score and diabetes remission were used as main observation indicators and the effects of CMNT on cognitive function and diabetes remission in type 2 diabetes patients with cognitive dysfunction were investigated from the perspective of reducing hyperglycemic load and regulating intestinal microbiota.

Description for medicine or protocol of treatment in detail：

Chinese Medicine Nutrition Therapy (CMNT) Introduction: A Chinese medicine nutrition therapy (CMNT) program of specific meal replacement food based on medicinal and food homophyte plants and whole grains designed for low calorie density medicinal food auxiliary ingredients include ganoderma lucidum mulberry leaf poria cocos yam pueraria root Cordyceps pupa and other medicinal and edible plants. It consists of four ready-to-eat foods including complex nutrition rice solid drinks meal replacement biscuits and fruit and vegetable porridge made mainly from whole grains and Chinese herbs which are standardized into 840 kcal/day (46% carbohydrate 46% fat 8% protein) ration box which participants only need to add boiling water to mix and then eat. Detailed components of CMNT can be found in the study proposal.

Inclusion criteria

Have been diagnosed with T2DM for at least 2 years according to the 2020 American Diabetes Association (ADA) Diabetes Standards; Have signs or symptoms of memory loss; 1 to 3 oral antidiabetic drugs (with or without insulin) stable treatment for at least 3 months or had not received antidiabetic drugs before the study began; Body mass index (BMI) between 18.0 and 35.0kg/m2; Stable weight (weight gain or weight loss <4 kg) for at least 3 months prior to the study; Age 60 to 75 years old more than 6 years of education no language visual impairment hearing impairment able to complete cognitive assessment and neuropsychological tests; Montreal cognitive assessment scale (MontrealCognitiveAssessmentScale MoCA) < 26 points (if the education time is less than 12 years add 1 point on the test results in order to correct cultural influence); Daily life ability by no apparent damage instrumental daily life ability scale (InstrumentalActivitiesofDailyLivingScale IADL) or 16 points; No evidence of infection infarction or other focal injury was detected by craniocerebral CT or MRI in the 12 months prior to screening and no related clinical symptoms. White matter lesions or lacunar infarction in non-critical brain areas can be allowed without affecting cognitive function; Ability to sign written informed consent; Able to successfully complete the run-in period of 2-3 weeks.

Exclusion criteria：

Have non-T2DM diabetes mellitus; Self-reported food allergies; Be hospitalized for any surgical treatment during screening; Physically or mentally unable to comply with the procedures required by the study protocol; Subjects with obvious auditory visual and language impairments affecting cognitive function tests; Grade 3 hypoglycemic events (at least 3) in the 90 days prior to screening; Hospitalization or emergency department visits due to hyperglycemia diabetic ketoacidosis lactic acidosis hyperosmolar nonketotic coma or diabetes; Have a serious medical condition that may affect cognitive function (such as the heart lungs liver kidneys and blood system); Previous history of cerebral vascular diseases such as cerebral infarction cerebral hemorrhage central infection brain tumor or other focal injury; Vascular dementia (Hachinski Ischemia Index Scale score ≥7) Alzheimer's disease Parkinson's disease and other neurological diseases that can cause dementia; A history of severe brain trauma resulting in persistent neurological deficits or brain structural abnormalities; Depression with a score of > 50 on the Self-rating AnxietyScale (SAS) or Self-ratingDepressionScale (SDS) within the past 2 years; Have a history of alcohol smoking drug abuse or dependence within the past 2 years; Use of the following classes of drugs in the 30 days prior to screening for cognitive impairment: Alzheimer's or dementia drugs anti-Parkinson's drugs short-acting antianxiety agents neurosedative or analgesic drugs antiepileptic drugs hormones drugs with significant cholinergic or anticholinergic side effects; A history of cancer within the past 5 years; Have New York Heart Association Class III or IV decompensated cardiac insufficiency; History of unstable angina pectoris coronary artery bypass grafting myocardial infarction or stent implantation; Pregnant or planning to become pregnant before or during the study; Other conditions in which the investigator or the medical expert in the study deems it inappropriate to participate.

Study execute time：

From 2024-12-01

To      2027-12-31

Recruiting time：

From 2024-12-01

To      2025-06-30

Interventions：

60

Group：

Control group (routine care group)

Sample size：

Intervention：

The control group received standard drug treatment and dietary recommendations provided by physicians following the "China Type 2 Diabetes Prevention and Treatment Guidelines 2020 Edition" and freely chose daily food. At the start of the study, all patients continued to take their originally prescribed antidiabetic medication, maintained their original exercise frequency, and participants self-reported adverse reactions during the intervention.

Intervention code：

60

Group：

Experimental group (CMNT group)

Sample size：

Intervention：

Participants in the CMNT group will eat the provided CMNT diet for 5 consecutive days in each intervention cycle, eating breakfast, lunch and dinner at the usual time between 06:30 and 08:30, 11:00 to 13:00 and 17:00 to 19:00, respectively. During these 5 days, participants will not consume any food outside the ration box. Then 10 days of normal eating, consistent with the control group, in a 15-day cycle for 6 consecutive cycles (3 months).

Intervention code：

Total sample size ： 120

Countries of recruitment
and research settings：

Country：

China

Province：

Hunan Province

City：

Changsha City

Institution/hospital：

Wangyue Lake Community Health Service Center, Yuelu District, Changsha City

Level of the institution：

Community Health Service Center

Outcomes：

Outcome：

CRP,IL-6

Type：

Secondary indicator

Measure time point of outcome：

Baseline and baseline to 3,6,12,24 months

Measure method：

Outcome：

Cognitive function score

Type：

Primary indicator

Measure time point of outcome：

Baseline and baseline to 361224 months

Measure method：

Montreal Cognitive Assessment ScaleMoCA

Outcome：

Glycosylated hemoglobin

Type：

Primary indicator

Measure time point of outcome：

Baseline and baseline to 3,6,12,24 months

Measure method：

Outcome：

Digit Symbol Substitution Test，DSST

Type：

Secondary indicator

Measure time point of outcome：

Baseline and baseline to 3,6,12,24 months

Measure method：

Scale measurement

Outcome：

Hypoglycemic drug dosage

Type：

Secondary indicator

Measure time point of outcome：

Baseline and drug dose adjustments

Measure method：

Applications and medical records

Outcome：

Anthropometric

Type：

Secondary indicator

Measure time point of outcome：

Baseline and baseline to 1,2,3,6,12,24 months

Measure method：

Outcome：

Self-Rating Anxiety ScaleSAS

Type：

Secondary indicator

Measure time point of outcome：

Baseline and baseline to 361224 months

Measure method：

Scale measurement

Outcome：

Intestinal flora metabolites

Type：

Secondary indicator

Measure time point of outcome：

Baseline and baseline to 3,6,12,24 months

Measure method：

Outcome：

Glucose metabolism

Type：

Secondary indicator

Measure time point of outcome：

Baseline and baseline to 3,6,12,24 months

Measure method：

Outcome：

Instrumental Activities of Daily Living Scale

Type：

Secondary indicator

Measure time point of outcome：

Baseline and baseline to 361224 months

Measure method：

Scale measurement

Outcome：

Self-rating Depression Scale

Type：

Secondary indicator

Measure time point of outcome：

Baseline and baseline to 361224 months

Measure method：

Scale measurement

Outcome：

Fried asthenic syndrome criteria

Type：

Secondary indicator

Measure time point of outcome：

Baseline and baseline to 361224 months

Measure method：

Scale measurement

Outcome：

Intestinal microbiome analysis

Type：

Secondary indicator

Measure time point of outcome：

Baseline and baseline to 3,6,12,24 months

Measure method：

16S rDNA

Outcome：

MRI

Type：

Secondary indicator

Measure time point of outcome：

Baseline and baseline to 3 months

Measure method：

Outcome：

Blood lipid

Type：

Secondary indicator

Measure time point of outcome：

Baseline and baseline to 3,6,12,24 months

Measure method：

Collecting sample(s)
from participants：

Sample Name：

blood

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

excrement

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

60
Min age years
75
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

Stratified randomization method was adopted for age and gender. A designated researcher was assigned to the study leader according to the random assignment order generated by a computer random number generator. The serial number of each subject corresponded to the random number generated in order the large random number group was CMNT group and the small random number group was usual care group. Participants were randomly assigned to either the CMNT group or the usual care group in a 1:1 ratio.

Blinding：

All the researchers who evaluated the results and analyzed the data were not aware of the grouping but the subjects and caregivers were.

IPD sharing：

Yes

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

China Clinical Trial Registry，https://www.chictr.org.cn/

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Use ResMan platform to collect and manage electronic data. The records are kept by the research team in a separate room in a locked drawer. Electronic data will be stored in a secure computer database in the form of password-protected files. Scientific reports generated from this study will be anonymous. Only authorized personnel have access to the randomized data and to the specialized information needed to perform the job. Study results will be sent to participants via email or phone.

Data Managemen Committee：

Yes

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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