2019
Sofia Kausar, Muhammad Arshad Abbas, Hajra Ahmad, Nazia Yousef, Zaheer Ahmed, Naheed Humayun, Hira Ashfaq and Ayesha Humayun

 

Abstract

Aim: The aim of the trial was to measure the effect of apple cider vinegar on glycemic control and biochemical parameters in type 2 diabetes mellitus (DM) patients with poor glycemic control.

Methods: A single-blind, randomized, placebo-controlled trial was conducted on 110 eligible types 2 DM patients who were selected and allocated into 2 groups. The interventional group was given 15 ml apple cider vinegar in 200 ml water during dinner for 3 months while the other group was placebo. Before and after HbA1C (glycosylated hemoglobin), fasting lipid profile, fasting blood sugar, anthropometrics, and dietary changes were assessed and analyzed using IBM SPSS version 20, through statistical tests. Formal ethical approval was obtained from the local institutional review board.

Results: Significant mean change was found in interventional group in HbA1c (p<0.001), blood sugar fasting (p<0.001), total cholesterol (p=0.002), triglyceride (p=0.002) and hip-waist ratio (p=0.002). No significant change was observed in the mean of these statistics in the placebo group. No significant change was observed in height, weight, mid-upper arm ratio, and low density lipoprotein, high density lipoprotein and food frequency in intervention and placebo groups before and after.

Conclusion: Apple cider vinegar if used regularly is effective in controlling diabetes, lowering hypercholesterolemia and hypertriglyceridemia in DM type 2 patients.

 

Keywords: Vinegar, Diabetes, Hyperglycemia, Hypercholesterolemia, Nutraceutical

Abbreviations: DM: Diabetes Mellitus; T2DM: Type 2 Diabetes Mellitus; ACV: Apple Cider Vinegar; HbA1c: A form of Hemoglobin (a blood Pigment that carries oxygen); LDL: Low Density Lipoproteins; HDL: High Density Lipoproteins; TC: Total Cholesterol; TG: Total Triglyceride; BMI: Body Mass Index; BSF: Blood Sugar Fasting; RCT: Randomized Control Trail; WHO: World Health Organization; SD: Standard Deviation; SPSS: Social Packages Statistical Software


Introduction

Diabetes mellitus (DM) has been considered globally as a major public health problem linked with changing life style,
reduced physical activity and obesity [1]. Development of diabetes mellitus is due to endocrine disorders which cause impaired insulin secretion, hepatic glucose over production and insulin resistance.

Complications can occur along with co-morbidities such as dyslipidemia, atherosclerosis, and hypertension [2]. World Health Organization (WHO) predicted DM to be the 7th cause of mortality by the year 2030 [3]. The 2013 estimates of the International Diabetes Federation (IDF) showed that about 382 million people globally have diabetes, and it will increase to 592 million by the year 2035. About 80% of populations with diabetes are from poor socioeconomic countries and 60% of them are from Asia whereas, one-third is from China. In developing countries, the rapid rise of type 2 DM is observed [4]. Prevalence of diabetes mellitus is found to be high in south Asian developing countries and India is topping the list. Pakistan is also facing a progressive increase in the diabetes burden. National level surveys showed DM prevalence of 13.14% in Punjab and 13.9% in Sindh [5].

Food additives which are grown by natural origin have been more popular in recent year for treating the diseases even without showing evidence of medical benefits. The ethnic, cultural and religious belief of various communities and easy access to internet information enhanced their preference for natural treatment remedies for various diseases [6].

Natural products have fewer side effects as compared to medical therapies, as perceived by the general population. Diabetics are 1.6 times more likely to use alternative medical products and complementary food than non-diabetics individuals [7]. Obese individuals are more likely to use alternative products or dietary supplements for reduction of their body weight and to gain other beneficial metabolic effects [6].

The word vinegar is derived from French word “vin aigre” meaning sour and it can be made almost from any fermentable sugar (carbohydrate) source such as apple, dates, grapes, and sorghum, etc. Acetic acid is an active component in apple cider vinegar responsible for its pungent, biting odour and tart flavour containing to 3%-9% acidity [2]. Apple cider vinegar is produced by fermenting apples in the form of an acidic solution. Its contain minerals, vitamins, and other trace elements and vinegar also contains a potent supply of potassium, as potassium is essential for
the replacement of worn-out tissues within the body and repair of soft tissue [8].

Apple cider vinegar has beneficial effects in the treatment of endocrinal, gastrointestinal, renal, neurological, nasal, joints, cardiovascular and muscular disorders and many skin infections.

Some studies reports showed that vinegar affects the glucose and insulin responses to a sucrose or starch load [8]. Acetic acid is the active component in apple cider vinegar which affects blood glucose metabolism and many other mechanisms which contribute to explain antiglycemic effects of vinegar. The mechanism by which vinegar reduces glucose levels are still unclear, acetic acid may slow gastric emptying [9]. Alternatively, acetic acid may inhibit disaccharides activity in the small intestine blocking the complete digestion of starch molecules and also promotes skeletal muscles glucose uptake in the body [10,11].

Vinegar usage improves hyperinsulinaemia, hypertriglyceridaemia, insulin sensitivity and can also reduce the level of random blood glucose in diabetic patients as well as in healthy individuals [12].

Evidence of many studies showed that a single dose of vinegar (20 g) with 5% acidity can decrease PPG (post prandial glucose) in diabetic as well as in healthy individuals by 50% [6,13]. This study showed that apple cider has anti-diabetic, anti-hyperlipidemic and anti-obesity effects in diabetes mellitus [6]. Insulin response and postprandial glucose can be influenced by type and dose of vinegar [13-15].

A randomized control trial (RCT) showed two different concentration of vinegar, 0.16%, and 1.6% found to be effective on 7th days of intervention onwards but not after 3rd day [8]. Many clinical trials found that apple cider vinegar can reduce obesity, hyperglycemia, hyperlipidemia, and hyperinsulinaemia. Emphasizing that apple vinegar is helpful for diabetes management as a complementary agent in diet [16,17].

A study conducted in pre-diabetic healthy individuals showed significant (p=0.05) reduction in HbA1C, in apple cider vinegar group [18]. Many RCTs of human and animals showed the hypolipidemic effects of ACV [19-21]. Antiobesity effect of apple cider vinegar is also found in many studies [22-24]. There is still a lot of research trials on the effectiveness of apple cider vinegar in different sets of the population of diabetes. The aim of the trial was to measure the effect of apple cider vinegar on glycemic control and biochemical parameters in type 2 DM patients with poor
glycemic control attending a tertiary care hospital in Lahore, Pakistan.

Discussion

In intervention and placebo groups, the mean age was not much different (51.1 ± 7.9 and 50.4 ± 7.7 respectively) with female predominance in both (61.8% in intervention group and 52.7% in placebo). A study conducted in Iran showed
a similar demographical picture of study participants but with different sample size [2,23]. The current study showed complications of diabetes including visual problem, neuropathy, and hypertension. While few studies documented no
complication in early diagnosed type 2 diabetic patients [18].

In the current study no significant change found in height, weight and mid upper arms circumference in both groups before and after. Hip/waist ratio significantly reduced after intervention (p=0.002) but no significant difference found in the placebo group (p=0.06). A study conducted in Japanese showed apple cider vinegar significantly reduced bodyweight, waist circumference, and BMI in vinegar treated group as compared to placebo [23]. Another animal study results highlighted significant reduction in daily gained and in routine body weight in normal healthy rats with normal diet and in obese rats with high calories diet in vinegar treated group but no significant change occurred in the placebo group [24]. The reason for the reduction in body weight and BMI may be due to the difference in the physiology of human and animals and dose of vinegar, duration of intervention and sample size.

In current study HbA1C and blood sugar fasting were significantly reduced in the intervention group, HbA1C (p<0.001), blood sugar fasting (p<0.001) no significant difference in mean of HbA1C, BSF in the placebo group.

Previous study results showed HbA1C (p=0.002) and BSF (p=0.006) significantly reduced in the intervention group but not significantly changed in these parameters of the placebo group [2]. Another study showed a significant reduction in fasting blood sugar (p=0.05), in vinegar (750 mg) ingestion group when compared with vinegar pills (40 mg acetic acid) as control group after 12 weeks trail but no significant change in Hb1C and post prandial glucose was found [18].

The results of the current study showed vinegar had a hypercholesterolemic and hypotriglyceridemic effect. Total cholesterol and triglyceride were significantly reduced in the intervention group (total cholesterol, p=0.002, and triglyceride, p=0.002), no significant change in the placebo group. An animal study showed that dietary acetic acid had efficacy to reduced hypercholesterolemia and hypertriglyceridaemia in vinegar ingestion group of rats but not in the placebo group [27].

HDL and LDL remained the same before and after intervention in intervention and placebo group. A study showed no significant difference in total cholesterol, total triglyceride LDL and HDL after one month intervention of white vinegar as compared to the placebo group [2]. The reason for the insignificant effect of vinegar on hyperlipidaemia could be a short duration of the intervention.

Another animal study showed a significant change in blood glucose, total cholesterol, LDL and HDL by indigestion of apple, coconut, grape, sugarcane and palm vinegar with apple cider vinegar most effective in triglyceride, LDL and glucose with 15% concentration for 6 weeks (p=0.005) [28]. Total cholesterol, triglyceride, LDL significantly reduced and HDL also increased but not significantly in hyperlipidemic patients in another study [19].

In the current study before and after intervention in groups, diet remained the same no significant difference was found in any food component before and after. Human subjects study results showed that diet should remain the same before and after the intervention of acetic acid in type 2 diabetic patients to ensure comparability [16].

Confounder variables including (age, gender, occupation, education, physical activity, exercise, walk, and sleeping) were found to have no effect on dependant variable (HbA1C) in both groups. A study conducted on human subjects showed physical activities and life style remained the same before and after the invention and no significant effect of these confounders was found [2].

The current limitation was a small sample size and financial constrains because this study was conducted without funding by any national and international organization. One-way ANOVAs (analysis of variance) for anthropometric measurements and biochemical assessments within groups showed insignificant findings.

 

Conclusion

The current study concludes that apple cider vinegar had a positive effect on controlling diabetes in diabetic patients and lowering hypercholesterolemia and hypertriglyceridemia. HbA1C, fasting blood glucose, total cholesterol, and triglyceride, and hip/waist circumference values were significantly reduced in the intervened group after 3 months of apple cider vinegar intervention. No significant change occurred in the values of LDL, HDL and body weight.

Physical activities, adequate sleep, diet plan follow up, adherence to prescribed medication and use of apple cider vinegar as a nutraceutical can be beneficial in reducing HbA1C, hypercholesterolemia, and hypertriglyceridemia in type 2 diabetic patients.

 

Declarations

Trial Registration
This clinical trial has been registered at www.clinicaltrials.gov, retrospectively, trial registration #NCT03593135, on 18th July 2018.

 

Acknowledgement

The researcher wants to thanks the administration and staff of Sheikh Zayed hospital Lahore especially diabetic clinic staff for their assistance and cooperation in data collection and all my study participants who took part in the research.

The research motivation behind publication was my worthy teachers and faculty members of the Department of Environmental Design, Health and Nutrition Sciences of AIOU Islamabad. Special thanks to Mr. Asim Jaja and Mr. Abdul Rehman for their assistance and guidelines in statistical analysis.

 

Conflict of Interest

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article