Chinese scientists have found that intermittent fasting based on traditional Chinese medicine nutrition therapy has made nearly half of patients with type 2 diabetes say goodbye to hypoglycemic drugs

Type 2 diabetes mellitus (T2D) is a lifelong disease, once you have T2D, most people may not be able to do without taking hypoglycemic drugs and insulin injections [1].

However, for patients with T2D who are in the early stage of the disease and have a short course of disease, it is expected that the blood glucose level will be controlled within the normal range through dietary intervention, weight control and other measures, thereby eliminating the patient's pain of taking drugs and injections [2, 3].

Intermittent fasting (IF) is arguably the most popular dietary strategy in recent years, helping to control weight and reduce body fat [4], which theoretically helps T2D patients control blood sugar, but its long-term effects in T2D patients have yet to be verified
.
In addition, complete fasting is not very suitable for T2D patients, which can lead to dangerous blood sugar levels, so the use of IF in T2D patients needs some improvement
.

Recently, Liu Dongbo's team from Hunan Agricultural University and Hu Minghai's team from Central South University published the results of a clinical study in the well-known endocrinology journal "Journal of Clinical Endocrinology and Metabolism" [5], showing that compared with the control group, receiving 3 months of traditional Chinese medicine nutrition therapy (CMNT), that is, intermittent fasting with a special diet, can make more T2D patients meet the criteria for diabetes remission (glycated hemoglobin A1c [HbA1c] is less than 6.
5%), and weight loss
。

Screenshot of the first page of the paper

CMNT is a dietary therapy based on IF, consisting of a 5-day CMNT diet and a 10-day normal diet, in which the CMNT diet not only contains grains such as wheat, barley, rice, rye and oats that are negatively associated with the risk of T2D incidence, but also contains goji berries, Ganoderma lucidum, yam, kudzu and other "medicinal and food-homologous" ingredients that promote insulin secretion and regulate intestinal flora, which is a low-calorie medicinal diet containing the wisdom of TCM food therapy [6].

In this randomized controlled clinical study (ChiCTR2000038036), participant recruitment began on January 2, 2019 and ended on June 2, 2020
.
Participants were aged 18 to 75 years with T2D with a body mass index (BMI) between
18 and 35.
Participants were randomized to either CMNT or control in a 1:1 ratio and entered into a 3-month intervention period
consisting of 6 cycles of 15 intervention days each.

In each cycle, the first 5 intervention days of the CMNT group were modified fasting days (approximately 840 kcal/day, 46% from carbohydrates, 46% from fat, and 8% from protein), during which participants received the CMNT diet at regular meal times, while on the remaining 10 intervention days they ate ad libitum as the control group and followed the Chinese Dietary Guidelines for Diabetes (2017 edition).

Participants were allowed to consume non-caloric beverages during the intervention, and participants in both groups maintained their usual exercise habits
.

CMNT diet list

After the 3-month intervention period, both the CMNT and control groups underwent an ad libitum diet (following the Chinese Dietary Guidelines for Diabetes).

The guidelines recommend a diet rich in fiber and low glycemic index carbohydrates, with 50 to 65 percent of total energy intake coming from carbohydrates, 15 to 20 percent from protein, and 20 to 30 percent from fat
.
The researchers followed participants at three and 12 months after the end of the intervention
.

Research flowchart

The primary endpoint of the study was diabetes remission rate, defined as a stable HbA1c level of less than 6.
5% after at least 3 months without taking antidiabetic drugs; Secondary endpoints of the studies included HbA1c levels, fasting blood glucose (FBG) levels, blood pressure, body weight, quality of life, and medication costs
.

A total of 72 participants were included, 36 each in the CMNT and control groups
.
Four participants withdrew from the CMNT diet group during the intervention phase due to relocation (n=1), time conflict (n=1), and loss to follow-up (n=2); Five participants withdrew from the control group
during the intervention phase due to timing conflicts (n=1), loss to follow-up (n=1), and no desire to continue (n=3).

Participants in both groups had similar characteristics at baseline, no significant differences in the types of drugs taken, and similar amounts of
medications.
The baseline HbA1c level was 7.
63% in the CMNT group and 7.
52% in the control group.
The baseline FBG was 8.
10mmol/L in the CMNT group and 7.
70mmol/L in the control group.
The baseline BMI was 20.
4 to 30.
4 in the CMNT group and 19.
1 to 29.
6
in the control group.

Baseline data for participants in both groups

At the end of the three-month intervention, 50.
0% (18/36) of participants in the CMNT group and 2.
8% (1/36) of participants in the control group stopped using antidiabetic drugs
.
At the same time, the average number of doses in the CMNT group was significantly lower than that in the control group (0.
59±0.
63 vs 1.
81±0.
67, P<0.
0001).

The FBG level in the CMNT group decreased to 6.
30 mmol/L after the intervention, which was significantly lower than the baseline level, while the FBG level in the control group was 7.
66 mmol/L after the intervention, with no significant difference
compared with the baseline level.
The effect of CMNT on the control of participants' body weight was also obvious, compared with a 0.
27 kg reduction in the control group, and the average weight loss of participants in the CMNT group at the end of the intervention was 5.
93 kg (P<0.
0001).

Participants in the CMNT group had an average reduction in BMI of 2.
41 compared with 0.
18
in the control group.

In addition, the mean blood pressure of participants decreased by an average of 0.
41 mmHg in the CMNT group and 1.
35 mmHg in the control group, and by 0.
75 mmHg in the CMNT group and 2.
58 mmHg in the control group, but there was no statistically significant difference
in diastolic or systolic blood pressure reduction between the two groups.
The quality of life score in the CMNT group increased by 4.
57 points from baseline, and the control group decreased by 1.
77 points (P<0.
05).

After 3 months of follow-up, 47.
2% (17/36) of participants in the CMNT group achieved diabetes remission, compared with only 2.
8% (OR 31.
32, P<0.
0001)
in the control group.
The HbA1c levels in CMNT group and control group were 5.
66% and 7.
87%, respectively, and the average HbA1c decrease in CMNT group (1.
75%) was significantly higher than that in control group (0.
37%)
.
The FBG was 5.
84mmol/L in the CMNT group and 7.
64mmol/L (P<0.
0001)
in the control group.

After 12 months of follow-up, 16 of the 36 participants in the CMNT group (44.
4%) achieved diabetes remission with a mean HbA1c level of 5.
90%, compared with no diabetes remission in the control group of 36 participants; The HbA1c levels and FBG levels of all participants in the CMNT group were 6.
33% and 6.
17 mmol/L, respectively, compared with 7.
76% and 7.
47 mmol/L (all P<0.
0001).

Participants achieved diabetes remission and HbA1c levels at 3 months and 12 months of follow-up

At 12 months of follow-up, participants in the CMNT group lost weight from 67.
60 kg to 61.
82 kg compared with baseline, while there was no significant change in weight in the control group (from 66.
25 kg to 66.
05 kg).

The BMI of participants was 22.
14 in the CMNT group and 23.
51
in the control group.
Compared to baseline, the quality of life score in the CMNT group increased by 6.
19 points, while the control group decreased by 2.
82 points (P<0.
05).

In addition, the control group took an average of 1.
85±0.
61 drugs, with an average cost of about 265.
1 yuan/month, while the CMNT group required fewer types of drugs (0.
61±0.
56) and lower costs (60.
4 yuan/month).

Overall, the researchers demonstrated the efficacy of IF therapy for diabetic patients for the first time through clinical trials, with nearly half of the subjects achieving diabetes remission at 12 months of follow-up after 3 months of CMNT therapy, and CMNT therapy also significantly reducing participants' HbA1c levels, FBG levels, and body weight
.

CMNT therapy is a sustained, moderately restricted calorie intake balanced diet developed by Professor Liu Dongbo's team, and according to the research carried out by Professor Liu Dongbo's team, the effect of CMNT therapy may be related to its increase in the number of beneficial intestinal flora, promote islet cells to secrete insulin, and improve patients' glucose tolerance [6], this clinical trial once again confirmed the effectiveness of CMNT therapy, and it is worth further exploration and promotion
in the future.

References:

1.
Taylor R, Ramachandran A, Yancy WS, Jr.
, Forouhi NG: Nutritional basis of type 2 diabetes remission.
BMJ 2021, 374:n1449.

2.
Lean MEJ, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C, Zhyzhneuskaya S, Al-Mrabeh A, Hollingsworth KG et al: Durability of a primary care-led weight-management intervention for remission of type 2 diabetes: 2-year results of the DiRECT open-label, cluster-randomised trial.
Lancet Diabetes Endocrinol 2019, 7(5):344-355.

3.
Taheri S, Zaghloul H, Chagoury O, Elhadad S, Ahmed SH, El Khatib N, Amona RA, El Nahas K, Suleiman N, Alnaama A et al: Effect of intensive lifestyle intervention on bodyweight and glycaemia in early type 2 diabetes (DIADEM-I): an open-label, parallel-group, randomised controlled trial.
Lancet Diabetes Endocrinol 2020, 8(6):477-489.

4.
Borgundvaag E, Mak J, Kramer CK: Metabolic Impact of Intermittent Fasting in Patients With Type 2 Diabetes Mellitus: A Systematic Review and Meta-analysis of Interventional Studies.
J Clin Endocrinol Metab 2021, 106(3):902-911.

5.
Yang X, Zhou J, Shao H, Huang B, Kang X, Wu R, Bian F, Hu M, Liu D: Effect of an Intermittent Calorie-restricted Diet on Type 2 Diabetes Remission: A Randomized Controlled Trial.
J Clin Endocrinol Metab 2022.

6.
Luo W, Zhou J, Yang X, Wu R, Liu H, Shao H, Huang B, Kang X, Yang L, Liu D: A Chinese medical nutrition therapy diet accompanied by intermittent energy restriction alleviates type 2 diabetes by enhancing pancreatic islet function and regulating gut microbiota composition.
Food Res Int 2022, 161:111744.