|Year : 2021 | Volume
| Issue : 2 | Page : 196-200
Intervention of a personalized low-carbohydrate diet to reduce HbA1c level and weight in patients with Type 2 diabetes using seed-based flour as replacement for high-carbohydrate flour and foods
Banshi Saboo1, Sanjeev Phatak2, Pratap Jethwani3, Rohan Patel1, Dhruvi Hasnani1, Dharmendra Panchal1, Smita Shah1, Vaishnavi Raval1, Roma Dave1, Anurag Mishra1
1 Diacare – Diabetes Care & Hormone Clinic, Ahmedabad, India
2 Vijayratna Diagnostic & Scientific Obesity Clinic, Ahmedabad, India
3 Jethwani Hospital, Rajkot, Gujarat, India
|Date of Submission||06-Aug-2020|
|Date of Decision||10-Dec-2020|
|Date of Acceptance||12-Dec-2020|
|Date of Web Publication||31-Mar-2021|
Dr. Banshi Saboo
Diacare – Diabetes Care & Hormone Clinic, Ahmedabad, Gujarat.
Source of Support: None, Conflict of Interest: None
Background: Globally, 425 million individuals were living with diabetes in 2017, and the numbers are expected to rise to 693 million by 2045. India, with more than 72 million people with type 2 diabetes mellitus (T2DM) in 2017, was reported to have the second largest population of individuals living with T2DM (https://www.diabetesatlas.org/upload/resources/previous/files/8/IDF_DA_8e-EN-final.pdf). The traditional Indian diet is heavily dependent on carbohydrates, and this acts as an obstacle for diabetes control. Carbohydrate restriction is associated with improvements in glycemic control and a reduction in the risk of the worsening of the disease and its complications. Objective: We investigate the real-world effectiveness of personalized carbohydrate reduction by using seed-based flour (sunflower seeds, pumpkin seeds, watermelon seeds, soya, and flaxseeds) with high-carbohydrate grain-based flour in the food along with remote health coach support for patients on the high glycated hemoglobin (HbA1c) levels and weight loss of patients. Materials and Methods: This study is a nonrandomized outpatient intervention focusing on adults with T2DM. With their consent, patients were enrolled from four clinics across Gujarat, Ahmedabad. The key inclusion criteria focused on patients with Hba1c between 7 and 10 with a body mass index more than 25 kg/m2 from 21 to 60 years of age. The key exclusion criteria were patients with advanced renal, cardiac, or liver dysfunction, pregnancy or planned pregnancy, historical ketoacidosis problems, and patients on SGLT2 inhibitors or pre-mix insulin. The intervention was personalized carbohydrate restriction. Patients were advised to avoid high-carbohydrate food categories such as grains, sugars, and high-carbohydrate fruits. They were advised to take seeds and nuts-based flour, nonstarchy vegetables, sprouts, and berries family fruits. Patients were also provided with recipes and options for all meals of the day. No restriction was made on the intake on nonstarchy vegetables. Patients were also provided with Diahappy Health’s Health coach to constantly provide remote support to resolve queries and doubts through phones. Duration of Study: For each participant, the study was carried out for 12 weeks at a stretch. Benefits: The study demonstrates an average 2.34% drop in HbA1c levels in participants who completed the program. There was also an average weight drop of 9 kg achieved in the participants.
Keywords: HbA1c, low-carbohydrate diet, Type 2 diabetes mellitus
|How to cite this article:|
Saboo B, Phatak S, Jethwani P, Patel R, Hasnani D, Panchal D, Shah S, Raval V, Dave R, Mishra A. Intervention of a personalized low-carbohydrate diet to reduce HbA1c level and weight in patients with Type 2 diabetes using seed-based flour as replacement for high-carbohydrate flour and foods. J Diabetol 2021;12:196-200
|How to cite this URL:|
Saboo B, Phatak S, Jethwani P, Patel R, Hasnani D, Panchal D, Shah S, Raval V, Dave R, Mishra A. Intervention of a personalized low-carbohydrate diet to reduce HbA1c level and weight in patients with Type 2 diabetes using seed-based flour as replacement for high-carbohydrate flour and foods. J Diabetol [serial online] 2021 [cited 2021 Dec 2];12:196-200. Available from: https://www.journalofdiabetology.org/text.asp?2021/12/2/196/312673
| Introduction|| |
Globally, 425 million individuals were living with diabetes in 2017, and the numbers are expected to rise to 693 million by 2045. India, with more than 72 million people with T2DM) in 2017, was reported to have the second largest population of individuals living with T2DM.
A recent study supported by the Indian Council for Medical Research-India Diabetes (ICMR-INDIAB) estimates the prevalence of T2DM in India to be 7.3% (95% CI 7.0–7.5).
This alarming rise of diabetes in India is further attributed to their phenotype.
Obesity, especially central obesity and higher weights in Indians, is one of the biggest reasons for the ever-increasing diabetic endemic in the country.
The resulting higher incidences of poor glycemic management and associated complications lead to an increased financial burden.
It is critical to integrate medical nutrition therapy (MNT) in the diabetes care mechanism to find better outcomes for patients. The MNT is an essential component of diabetes management that comprises counseling and recommendations for dietary intake and nutrition goals by a registered dietician (RD) or a nutrition expert to optimize metabolic control and maximize treatment outcomes. The MNT involves integrated efforts from the RD and diabetologist along with patient self-management and conscientiousness.
The traditional Indian diet is heavily dependent on carbohydrates. This acts as an obstacle for diabetes control. Carbohydrate restriction is associated with improvements in glycemic control and a reduction in the risk of the worsening of the disease and its complications. Indians typically consume around 65% of calories though carbohydrates and are heavily dependent on their staple grains consumption.
There is a consensus to reduce carbohydrate intake to see effective glycemic control and weight improvement among people. The dependence on carbohydrates and their affinity to their plate compositions has been a major hindrance in achieving expected health outcomes among patients. Lack of alternatives to higher carbohydrate food products in the Indian diet is and would be a major challenge in solving the diabetes and obesity endemic in the country.
| Background|| |
It is important to find an effective method to reduce the overall carbohydrate consumption in food.
Based on the conditions, we envisaged to replace high-carbohydrate food products from the plates with seeds-and-nuts-based products and to document the outcomes from the observations. In a 12-week study, we investigated the real-world effectiveness of personalized carbohydrate reduction by using seed-based alternatives to high-carbohydrate staples in the food along with remote health coach support for patients on the high HbA1c levels and weight loss of patients.
| Materials and Methods|| |
Trial design and participants
We conducted a 12-week observational study. The study included single-arm, pre- and postinterventional assessment of HbA1c, weight in a convenience sample of adults.
Participants were recruited from four clinics and were referred by their treating physicians. Patients expressed interest by filling a preregistration form. The patients underwent a prescreening review based on the inclusion and exclusion criteria.
- a. Patient Selection—Inclusion criteria: The target patients should satisfy the criteria given next:
- They should have T2DM with HBA1c greater than 7 and less than 10
- Their BMI should be greater than 25 kg/m2
- They should range from 21 to 60 years of age
- They should have an Android smartphone and should be capable of operating a smartphone app.
- They should be willing to undertake a 12-week focused lifestyle training on the application
- They should have a minimum one-year diabetic history
- b. Patient selection—exclusion criteria: The target patients should not have the following health conditions:
- Advanced renal, cardiac, or liver dysfunction
- Pregnancy or planned pregnancy
- Historical ketoacidosis problems
- Substance abuse
- People with dietary fat intolerance
- They should not have undergone a weight loss of more than 5 kg in the past six months
- They should not have had myocardial infarction within the previous six months
- They should not be currently undergoing treatment with any antiobesity drugs
- They should not be diagnosed as having an eating disorder or purging
- They should not be taking SGLT2 medication
- They should not be undergoing any other clinical research trial
- They should not be taking pre-mix insulin
The intervention was a 12-week program that was focused on replacing high-carbohydrate food items from the patient’s diet with seed-based less carbohydrate options and replacements. The product replacements were suggested by Diahappy Health by the physicians. All the enrolled patients were taken through a counseling session to understand their dietary patterns and they were suggested replacements for all high-carbohydrate foods. Patients were advised to avoid high-carbohydrate food categories such as grains, sugars, and high-carbohydrate fruits. They were advised to take seeds and nuts-based flour, nonstarchy vegetables, sprouts, and berries family fruits. The patients were also provided with recipes and options for all meals of the day. No restriction was made on the intake of nonstarchy vegetables. Patients were also provided with Diahappy Health’s Health coach to constantly provide remote support to resolve queries and doubts through phones. During the program, the health coach guided the participants to make low-carbohydrate food choices. The participants were specifically asked not to make any change in their physical activity levels. The program adopted a clear philosophy of reducing carbohydrates from grains, sugars, and high-fructose fruits while providing alternates through seeds-and-nuts-based options. Patients were also provided with seed-based flour. The flour had the following nutrition compositions in 100g (approx.): calories: 396 kcal; total carbohydrate: 28.7g; dietary fiber: 13.7; net carbohydrate: 14g; protein, 39.2g; fat: 19g. The flour was made of sunflower seeds, pumpkin seeds, watermelon seeds, soya flour, wheat bran fiber, isolated wheat protein, psyllium husk, and guar gum. Patients were also provided with glucometers to measure their blood glucose levels at their homes.
The patient physically visited the physician at both the start and the end of the trial. At the end of the second, fourth, and eighth weeks, the patient could either visit or have a telephonic call to update on the status.
The biochemical tests mentioned next were conducted at both the start and the end of the trial for all the patients:
Fasting blood sugar
γ-Glutamyl transpeptidase (GGTP)
Primary outcome measures
The primary outcomes of the study included a change in HbA1c and weight loss at the completion of the program (12 weeks).
Secondary outcome measures
The secondary outcomes of the study included a change in low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides, t3, t4, thyroid stimulating hormone (TSH), creatinine, uric acid, GGTP, and high sensitivity C-reactive protein.
The study enrolled 100 patients. Overall, 80 patients completed the 12-week study.
[Table 1] contains the baseline summary of the participants. Of the 80 participants, 55 (69%) were male and 25 (31%) were female.
|Table 1: Completed patient characteristics. Data are as mean ± standard deviation|
Click here to view
Descriptive statistics were calculated for each variable as mean (SD). Baseline and 12-week follow-up results were compared with paired-sample t tests to evaluate for significant differences in primary (HbA1c level) and secondary outcome variables over time.
| Results|| |
The study enrolled 100 patients. Overall, 80 patients completed the 12-week study.
Change in HbA1c and weight
Among the participants who completed the study, the mean HbA1c drop was 2.33%. Overall, 68 (85%) patients experienced an HbA1c drop of 6.5% [Table 2]. The percentage difference was calculated by dividing the difference between pre- and post-study value by the pre-study value.
Change in weight
Among the participants who completed the study, the mean weight drop was 9 kg. The mean drop in men was 10.3 kg whereas it was 6.1 kg in women. It has been observed that the program resulted in higher weight loss for men compared with women [Table 3] and [Graph 1].
Change in other biomarkers
The other biomarkers were recorded both before and after the 12 weeks and they have been shown in [Table 4]. The average LDL increased by 6.44 (mg/dL) unit. There was an average improvement in the GGTP by 9.4 (U/I) along with a 34.99 (mg/dL) improvement in triglycerides.
| Discussion|| |
The study has demonstrated a drop in HbA1C from an average 8.65 to 6.31 in a 12-week period. The drop is 27% with P < 0.01. The improvement in HbA1c demonstrates that the carbohydrate reduction achieved by replacing grain-based flour with seed-based flour would be an effective way to manage T2DM. The average weight drop of 9 kg, effectively resulting in an 11% drop with P < 0.01, demonstrates significant improvement. Several studies have shown that a drop of 5% weight would be a significant measure in diabetes control.
The study has demonstrated that the reduction in carbohydrate has resulted in significant reduction in triglycerides and improvement in HDL. There has been an increase in LDL cholesterol, leading to an increase in total cholesterol. The significant improvement in triglycerides could be attributed to less requirement of the body to convert the glucose from carbohydrates to triglycerides due to a reduction in carbohydrate intake. It could also be attributed to reduced weight. The study findings can be explored further to evaluate the change.
Studies have shown that higher omega-3 and omega-6 fats have been inversely related to cardiovascular diseases and T2DM., Seeds, especially sunflower seeds, pumpkin seeds, watermelon seeds, and flaxseeds, are a great source of omega-3 and omega-6 fats while simultaneously reducing the carbohydrates.
To the best of our knowledge, this pilot study is the first in India to report the effectiveness of a personalized low-carbohydrate diet by replacing high-carbohydrate products with seed-based formulations. The study assessed the effectiveness of the intervention to improve glycemic control (reduction in HbA1c levels) and the relationship between a low-carbohydrate diet and finding a replacement for high-carbohydrate staple foods in the form of seed-based formulations. The effectiveness and meaningful impact of the intervention was demonstrated by the significant reduction in HbA1c levels and weight loss. The real-world feasibility and acceptance was demonstrated by 80% (80/100) participants completing the three months of the program.
A 0.5% to 1% change in HbA1c is considered clinically relevant to reduce the risk of comorbid conditions. A weight drop of 5% is considered clinically significant.
The results of the United Kingdom Prospective Diabetes Study (UKPDS) indicated that a 0.9% decrease in HbA1c was associated with a 25% reduction in microvascular complications, a 10% decrease in diabetes-related mortality, and a 6% reduction in all-cause mortality.
Some of the limitations of this study include the single-cohort, nonrandomized design; the study was conducted for a short duration of 12 weeks. We could not independently verify whether the participants were following the suggestions and guidance in a 100% compliant manner.
There was a 20% dropout among participants due to noncompliance of the diet, which shows that not everybody could follow the program. The strength of the study was to ensure participants who could follow the program achieved outcomes without impacting their daily life. The study findings can be explored further to evaluate the long-term acceptability, cost-effectiveness, and durability of the principal findings and its feasibility to be applied to a larger, culturally similar population.
| Conclusions|| |
Carbohydrate reduction is an effective and affordable approach that can be an indispensable part of T2DM and obesity prevention and management. It is also important. Replacing the high-carbohydrate staple foods made from grain-based flours with seeds-and-nuts-based flour will be an effective way to reduce carbohydrate intake. The replacement should be monitored by RDs and doctors while keeping in mind historic health conditions. Overall, it should motivate individuals to make better health choices and engage in healthy eating.
The authors would like to thank all the participants who took park in this study, the Research Society for the Study for Diabetes in India for their support.
Financial support and sponsorship
Participants were not compensated for their participation. All the funding was provided by Diahappy Health Pvt Ltd.
Conflicts of interest
Mr. Anurag Mishra is the CEO and shareholder in Diahappy Health Private Limited and Dr. Banshi Saboo is an advisor to them.
Ethics committee approval was obtained for the study. “Thackershy Charitable Trust Ethics Committee” (Registration no. ECR/696/Inst/GJ/2014/RR-18) gave the approval for the trial.
Declaration of patient consent
Written informed consent for using their de-identified data for clinical research was obtained from each participant before enrolment in the program. Participation in the study was voluntary, and refusal to grant consent for the use of their de-identified data for research did not affect the participants’ enrolment in the program or the quality of care administered to them.
Biochemical assessment methods
HbA1C: HPLC method
Lipid Profile: spectrophotometry
Thyroid Profile: ECLIA
Creatinine: Jaffe’s method compensated
Uric Acid: Enzymatic (uricase)
hsCRP: Particle-enhanced turbidimetry (PETIA)
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[Table 1], [Table 2], [Table 3], [Table 4]