Effect of Apple Cider Vinegar in Type 2 Diabetics
Condition: Randomized Controlled Trial; Diabetes Mellitus
Study type: Interventional

Summary: 
      Background: apple cider vinegar is natural traditional health beneficial nutraceutical used
      for many aliments. Diabetes mellitus (DM) has been considered a globally major health problem
      and posing health burden on families and health system. Diabetes is associated with life
      style that leading to reduce physical activities and increased in obesity. For development of
      diabetes the known mechanism are endocrine disorders which cause impaired insulin secretion,
      hepatic glucose over production and insulin resistance.

      Objective: The aim of current randomized controlled trial was to investigate the effect of
      apple cider vinegar on glycemic control and biochemical parameters in type 2 diabetic
      patients with poor glycaemic control.

      Material & Methods: 110 type 2 diabetic patients according to inclusion criteria were
      selected and divided into two groups. Interventional group was given 15 ml apple cider
      vinegar in 200ml water during meal at night time for 3 months. Before and after HbA1C,
      fasting lipid profile, fasting blood sugar, anthropometrics and dietary changes were assessed
      and analyzed using IBM SPSS version 20 through paired sample T-test where needed.

      .
    

Detailed description: 
      A study conducted in pre-diabetic healthy individuals showed significant (p=0.05) reduction
      in HbA1C, in apple cider vinegar group . Many RCTs of human and animals showed hypolipidemic
      effects of ACV. Anti obesity effect of apple cider vinegar also found in many studies. There
      is still lot of work going on and this present study is conducted with an objective to
      measure the effect of apple cider vinegar on HbA1c, fasting blood glucose, fasting lipid
      profile and body weight.

      METHOD:

      STUDY DESIGN AND SETTING

      This study was a single-blind, randomized-controlled placebo trial. Trial period was three
      months from August 15, to November 15, 2017. This study was conducted at a 1050 beded
      tertiary care, teaching hospital of Lahore, Pakistan. This hospital has high diabetics
      out-patient turnover as being a reputable center in management of diabetes.

      PARTICIPANTS:

      Adult patients having type 2 diabetes, of both genders with age range from 30-60 years were
      included. All having BMI between 20-30, non smoker and non alcoholics and all were on
      standard medical therapy for diabetes (including Metformin + Sitagliptin group). Patients
      suffering from known chronic renal disease and history of cardiovascular diseases like
      stroke, ischemic heart disease and known allergy or intolerance to vinegar, reported by the
      patient or relative and any kind of acute infection were excluded from study.

      The sample size of 110 (55 in each group) was estimated by using 95% confidence level,80%
      power with expected mean change in HbA1c 0.53% and 0.11% for cases treated with apple vinegar
      and placebo respectively with a SD of 0.77% (by using power + precision 3.0 software).
      Assuming a 12.6% non-response rate, RCT started with 126 patients, 63 patients in each group.
      16 patients were lost to follow up during study period, so finally statistical analysis was
      done on 110 patients 55 in each group.

      DEPENDENT VARIABLES: A structured questionnaire was used for collecting respondents'
      information. Blood samples were taken for biochemical test (HbA1c, lipid profile and fasting
      blood glucose) and anthropometrics measurements were done.

      Anthropometric measurements: Height was measured in centimeter to nearest 0.1 cm by using
      standard stadiometer before intervention and weight was measured in kilogram to nearest 100 g
      with wearing light cloth by using a calibrated weighing scale machine before and after
      intervention. Hip/waist ratio and mid upper arm were measured with measuring tape in
      centimeter to nearest 0.1cm. The BMI of study participants were classified as underweight,
      normal, over weight and obese according to WHO criteria weight was measured as weight
      (kg)/height (cm)2.

      Biochemical assessments:

      At before start of intervention and after intervention 5ml venous blood sample was taken with
      12hours fasting for biochemical assessments including blood sugar fasting, HbA1C (glycated
      hemoglobin), total cholesterol, low density lipoprotein, high density lipoprotein and
      triglyceride were evaluated.

      CONFOUNDING VARIABLES:

      Dietary intake:

      Diet of study participants can influence and confound the intervention during study period so
      it was assessed through food frequency questionnaire. Food frequency was filled two times
      before and after intervention to measure change during study period which can actually
      confound the effect of apple cider vinegar. The food frequency questionnaire was structured
      according to Pakistan's cultural food preferences and choices. FFQs contained methods of food
      preparation, frequency per day and per week and portion size/ amount of food consumed in
      categories from never, monthly to 1-7 days in a week. Food exchange lists were used to assess
      the portion size of food. FFQ composed of cereal group, fruits, vegetable, meat, milk,
      fat/oil, snacks and beverages.

      INDEPENDENT VARIABLE/ INTERVENTION: This selected nutraceutical (Apple cider vinegar) was
      given for three months. Apple cider vinegar was provided to patients and instructions were
      given to all participants about the uses of apple cider vinegar and strictly follow the
      prescribed nutraceutical given as per following schedule; Group I: Intervention group
      Intervention group taking their diet according to their original meal pattern only dietary
      guideline were given regarding high glycaemic and low glycaemic diet. Medical treatments
      continued (including Metformin + Sitagliptin group). 15ml apple cider vinegar (American
      garden organic vinegar) (containing 5% acetic acid) mixed in 200ml water during meal at night
      time was prescribed.

      Group II: comparison group Control group also taking their diet according to their original
      meal pattern only dietary guideline were given regarding high glycaemic and low glycaemic
      diet. Medical treatment continued (including Metformin + Sitagliptin group). 15ml apple cider
      vinegar (flavor of ACV in plan water was used as placebo) mixed in 200ml plain water during
      meal at night time.

      Statistical analysis:

      Descriptive statistical analysis was done for demographic profile, categorical and numerical
      variables by measuring frequency, percentage, mean and standard deviation of all samples.
      Paired sample T test was used for anthropometrics measurement and biochemical assessment for
      two time assessment before and after intervention. Independent sample t-test was used for
      comparison between groups. Where needed ANOVA was also applied. McNemar statistical test was
      used to assess the food frequency questionnaire before and after intervention.

      Ethical considerations:

      Proper ethical clearance was obtained from Institutional Review Board of Shaikh Zayed Medical
      Complex before starting the trial.
    

Intervention name(s): Apple Cider Vinegar and tablet Tagipmet (Metformin + Sitagliptin group); Water with Apple Cider vinegar flavor and tablet Tagipmet (Metformin + Sitagliptin group)
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 15ml apple cider vinegar (American garden organic vinegar) (containing 5% acetic acid) mixed in 200ml water during meal at night time, for 3 months and tablet Tagipmet 50mg/1000mg (Metformin + Sitagliptin group) twice a day. NOTE medical treatment is our inclusion criteria.; Flavor of apple cider vinegar in 200 ml water is added and given to have a placebo effect and tablet Tagipmet 50mg/1000mg (Metformin + Sitagliptin group) twice a day. NOTE medical treatment is our inclusion criteria.
Other intervention name(s): intervention; Placebo
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Acetic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: vinegar; diabetes; hyperglycemia; hypercholesterolemia; nutraceutical