Metabolic Syndrome
Conditions
Brief summary
After taking written informed consent patients, the selected participants were divided into control and experimental group randomly.
Detailed description
Phase II: RCT Double- Blinded After the approval from the relevant authorities from The University of Lahore and Hospital, individuals meeting the ATP III criteria for metabolic syndrome (n = 330) will be selected for inclusion after taking consent. The selected participants will be randomly divided into control and experimental groups. Anthropometric measurements, socio-economic status, nutrient intake and biochemical tests as fasting blood sugar level, triglyceride and cholesterol levels were taken at beginning (0 day) and 60 days. The study was conducted in three steps respectively I: Baseline Data II: Intervention III: Follow Up I: Baseline Data Interview technique accompanied with questionnaire was used to get following information. Before intervention metabolic syndrome patients were assessed for: Demographic Data: The basic information based on demographic data such as age, gender, marital status, education, was taken. A. Anthropometrics Height and Weight of the patients were measured in light clothing using stadiometer. Waist circumference were measured using a inches tape. Body mass index an indicator of nutritional status, is deliberated by individual's body weight in kg divided by the height in meter square (kg/m2)56. B. Biochemical tests Blood pressure will be measured by a sphygmomanometer after a 15-minute rest in sitting position56. Biomarkers (biochemical tests) as Fasting blood glucose (FBS), Lipid profile (total cholesterol, high density lipoprotein (HDL), Low Density Lipoprotein (LDL) and triglyceride levels), Liver functioning tests (LFT's) and Renal functioning tests were recorded. Blood samples (10 mL) were taken after 12 to 14 hours of fasting state at the beginning and after 8 weeks of intervention. Fasting serum glucose, TG, TC, LDL-C, HDL, were determined . Liver functioning tests Alanine transferase (ALT), Aspartate transferase (AST), and alkaline phosphatase (ALP) and kidney functioning tests were performed. C. Clinical Findings The metabolic syndrome patients were assessed clinically to have an insight into nutritional deficiencies on the bases of sign and symptoms. D. Dietary Recall/Data 24 hr recall and Food frequency checklist were used to assess the dietary intake of the patients II: Intervention T0: Control group on Carbohydrate Controlled Diet with conventional therapy T1: Intervention with Carbohydrate Controlled Diet along with Cumin Seeds Tea T2: Intervention with Carbohydrate Controlled Diet along with Ginger Tea T3: Intervention with Carbohydrate Controlled Diet along with Lemon Peel Tea T4: Intervention with Carbohydrate Controlled Diet along with Functional tea bags Respondents / Metabolic syndrome patients were categorized into 5 groups and will be intervened for 2 months (60 days). Functional tea bags were given to patient and thereby instructed to consume/have tea twice a day i.e. in mid-morning and at evening without sugar and a standard cup size of 200 ml respectively. The preparation involved boiling 200 ml of water with 2 grams of cumin seeds Patients were instructed to consume/ have tea twice a day i.e. in mid-morning and in the evening without sugar respectively. III: Follow up During data collection the patient were informed to weekly on call follow up through their provided contact numbers. On call follow up were taken after every 2 weeks (15 days) to determine the Follow up/ dropout rate or any side effect being encountered by the patient. Patient were advised to visit the hospital after every fifteen days so that compliance was monitored and functional tea bags were given for respective days/ months and instance if there were any issue/ side effect that could be treated/ adjusted/ eliminated accordingly. Reassessment: After eight weeks Anthropometric and biochemical tests of patients will be taken to assess the result of intervention. Data collection tool * ATP III Criteria * Questionnaire (Demographic profile) * Food Frequency Checklist (FFQ) * 24 hr Recall
Interventions
DIETARY_SUPPLEMENTCumin tea
The preparation involved boiling 200 ml of water with 2 grams of cumin seeds. Patients were instructed to consume/ have tea twice a day i.e. in mid-morning and in the evening without sugar respectively.
DIETARY_SUPPLEMENTGinger Tea
The preparation involved boiling 200 ml of water with 2 grams of ginger. Patients were instructed to consume/ have tea twice a day i.e. in mid-morning and in the evening without sugar respectively.
DIETARY_SUPPLEMENTLemon Peel Tea
The preparation involved boiling 200 ml of water with 2 grams of lemon peel. Patients were instructed to consume/ have tea twice a day i.e. in mid-morning and in the evening without sugar respectively.
DIETARY_SUPPLEMENTFunctional Tea
The preparation involved boiling 200 ml of water with 2 grams of functional tisane (0.6 g cumin seeds, 0.6 g ginger, and 0.6 g lemon peel) Patients were instructed to consume/ have tea twice a day i.e. in mid-morning and in the evening without sugar respectively.
DIETARY_SUPPLEMENTConventional therapy
A carbohydrate-controlled diet focuses on limiting refined carbohydrates and sugars and total carbohydrate restriction to 50-70gm per major meal.
Sponsors
University of Lahore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Masking description
Double- Blinded
Intervention model description
After the approval from the relevant authorities from The University of Lahore and Hospital, individuals meeting the ATP III criteria for metabolic syndrome (n = 330) will be selected for inclusion after taking consent. The selected participants will be randomly divided into control and 4 experimental groups. Anthropometric measurements, socio-economic status, nutrient intake and biochemical tests as fasting blood sugar level, triglyceride and cholesterol levels will be taken at beginning (0 day) and 60 days.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Metabolic syndrome patients either gender of 18 to 60 years will be included. * Patients will be recruited on the basis of ATP III criteria * Patients having any body mass index with confirmed diagnosis of Metabolic Syndrome and no use of any dietary supplement or no adherence to special diets at least one month prior to baseline
Exclusion criteria
Individuals with the following conditions will not be included as participants * Genetically obese individuals * Patients already on lipid lower drugs according to recommendation of physicians * Patients taking any nutritional supplement * Allergy to any drugs or specific foods * Breastfeeding mothers * Pregnant females * Patients with any other medical history (renal diseases, infections, liver disorders, cardiovascular diseases) * Patients receiving weight loss drugs or supplements, receiving any changes in diet or daily exercise programs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Waist Circumference | 60 days | Normal range of waist circumference in men should be less than 40 inches and in women it should be less than 35 inches. Change in the waist circumference will be monitored during the trial. \>102 cm ( \>40 in ) \>88 cm ( \>35 in ) |
| Serum Triglyceride Level | 60 days | Change in serum Triglyceride Level were monitored before and after the trial |
| Serum HDL- Cholesterol Level | 60 days | Change in Levels were monitored before and after the trial |
| Blood Pressure (Systolic and Diastolic) | 60 days | Change in readings were monitored before and after the trial |
| Fasting Glucose Level | 60 days | Change in readings were monitored before and after the trial |
Countries
Pakistan
Outcome results
None listed