• Users Online: 466
  • Print this page
  • Email this page


 
 Table of Contents  
ORIGINAL ARTICLES
Year : 2021  |  Volume : 12  |  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


1 Diacare – Diabetes Care & Hormone Clinic, Ahmedabad, India
2 Vijayratna Diagnostic & Scientific Obesity Clinic, Ahmedabad, India
3 Jethwani Hospital, Rajkot, Gujarat, India

Date of Submission06-Aug-2020
Date of Decision10-Dec-2020
Date of Acceptance12-Dec-2020
Date of Web Publication31-Mar-2021

Correspondence Address:
Dr. Banshi Saboo
Diacare – Diabetes Care & Hormone Clinic, Ahmedabad, Gujarat.
India
Login to access the Email id

Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jod.jod_74_20

Rights and Permissions
  Abstract 

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 Apr 12];12:196-200. Available from: https://www.journalofdiabetology.org/text.asp?2021/12/2/196/312673




  Introduction Top


Background

Globally, 425 million individuals were living with diabetes in 2017, and the numbers are expected to rise to 693 million by 2045.[1] India, with more than 72 million people with T2DM) in 2017, was reported to have the second largest population of individuals living with T2DM.[1]

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).[2]

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.[3]

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.[4]

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.[5]

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.[6]


  Background Top


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 Top


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


Intervention

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:

  • HBA1c


  • Fasting blood sugar


  • Fasting insulin


  • γ-Glutamyl transpeptidase (GGTP)


  • Lipid profile


  • Creatinine levels


  • Blood pressure


  • 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.

    Participants

    The study enrolled 100 patients. Overall, 80 patients completed the 12-week study.

    Sociodemographics

    [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


    Statistical analysis

    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 Top


    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.
    Table 2: Change in HbA1c

    Click here to view


    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].
    Table 3: Change in weight

    Click here to view
    Graph 1: Change in weight and HbA1c: Pre- and post-12 weeks

    Click here to view


    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.
    Table 4: Change in biomarkers of completed participants (N = 80)

    Click here to view



      Discussion Top


    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.[7]

    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.[8],[9] 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.

    First principle

    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.

    Limitations

    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 Top


    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.

    Acknowledgments

    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.

    Ethical approval

    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)

    GGTP: IFCC

    hsCRP: Particle-enhanced turbidimetry (PETIA)



     
      References Top

    1.
    IDF Diabetes Atlas. Eighth Edition: International Diabetes Federation; 2017 [2018 April 10]. https://www.diabetesatlas.org/upload/resources/previous/files/8/IDF_DA_8e-EN-final.pdf. Accessed 2018 April 10.  Back to cited text no. 1
        
    2.
    Anjana RM, Deepa M, Pradeepa R, Mahanta J, Narain K, Das HK, et al; ICMR–INDIAB Collaborative Study Group. Prevalence of diabetes and prediabetes in 15 states of India: Results from the ICMR-INDIAB population-based cross-sectional study. Lancet Diabetes Endocrinol 2017;5:585-96.  Back to cited text no. 2
        
    3.
    Wells JC, Pomeroy E, Walimbe SR, Popkin BM, Yajnik CS The elevated susceptibility to diabetes in India: An evolutionary perspective. Front Public Health 2016;4:145.  Back to cited text no. 3
        
    4.
    Viswanathan V, Krishnan D, Kalra S, Chawla R, Tiwaskar M, Saboo B, et al. Insights on medical nutrition therapy for type 2 diabetes mellitus: An Indian perspective. Adv Ther 2019;36: 520-47.  Back to cited text no. 4
        
    5.
    Mohan V, Unnikrishnan R, Shobana S, Malavika M, Anjana RM, Sudha V Are excess carbohydrates the main link to diabetes & its complications in Asians? Indian J Med Res 2018;148:531-8.  Back to cited text no. 5
        
    6.
    Wylie-Rosett J, Aebersold K, Conlon B, Isasi CR, Ostrovsky NW Health effects of low-carbohydrate diets: Where should new research go? Curr Diab Rep 2013;13:271-8.  Back to cited text no. 6
        
    7.
    Wilding JP The importance of weight management in type 2 diabetes mellitus. Int J Clin Pract 2014;68:682-91.  Back to cited text no. 7
        
    8.
    Forouhi NG, Krauss RM, Taubes G, Willett W Dietary fat and cardiometabolic health: Evidence, controversies, and consensus for guidance. BMJ 2018;361:k2139.  Back to cited text no. 8
        
    9.
    Del Gobbo LC, Imamura F, Aslibekyan S, Marklund M, Virtanen JK, Wennberg M, et al; Cohorts for Heart and Aging Research in Genomic Epidemiology (CHARGE) Fatty Acids and Outcomes Research Consortium (FORCe). Ω-3 polyunsaturated fatty acid biomarkers and coronary heart disease: Pooling project of 19 cohort studies. JAMA Intern Med 2016;176:1155-66.  Back to cited text no. 9
        


        Figures

      [Figure 1]
     
     
        Tables

      [Table 1], [Table 2], [Table 3], [Table 4]



     

    Top
     
     
      Search
     
    Similar in PUBMED
       Search Pubmed for
       Search in Google Scholar for
     Related articles
    Access Statistics
    Email Alert *
    Add to My List *
    * Registration required (free)

     
      In this article
    Abstract
    Introduction
    Background
    Materials and Me...
    Results
    Discussion
    Conclusions
    References
    Article Figures
    Article Tables

     Article Access Statistics
        Viewed414    
        Printed8    
        Emailed0    
        PDF Downloaded19    
        Comments [Add]    

    Recommend this journal


    [TAG2]
    [TAG3]
    [TAG4]