Clinical trial NCT06728449: Influence of Herbal Infusion on Metabolic Syndrome
Official title: Influence of Herbal Infusion of Cumin Seed, Ginger Root and Lemon Peel on Clinical Outcomes Among Patients With Hyperuricemia Associated Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: Waist Circumference
timeFrame: 60 days
measure: Serum Triglyceride Level
timeFrame: 60 days
measure: Serum HDL- Cholesterol Level
timeFrame: 60 days
measure: Blood Pressure (Systolic and Diastolic)
timeFrame: 60 days
measure: Fasting Glucose Level
timeFrame: 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: University of Lahore Teaching Hospital
state: Punjab
Study officials:
affiliation: University of Lahore
name: Maria Aslam
role: PRINCIPAL_INVESTIGATOR
References:
citation: Taghizadeh M, Memarzadeh MR, Abedi F, Sharifi N, Karamali F, Fakhrieh Kashan Z, Asemi Z. The Effect of Cumin cyminum L. Plus Lime Administration on Weight Loss and Metabolic Status in Overweight Subjects: A Randomized Double-Blind Placebo-Controlled Clinical Trial. Iran Red Crescent Med J. 2016 May 23;18(8):e34212. doi: 10.5812/ircmj.34212. eCollection 2016 Aug.