Influence of Herbal Infusion on Metabolic Syndrome

Influence of Herbal Infusion of Cumin Seed, Ginger Root and Lemon Peel on Clinical Outcomes Among Patients With Hyperuricemia Associated Metabolic Syndrome

After taking written informed consent patients, the selected participants were divided into control and experimental group randomly.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Dietary supplement: Conventional therapy; Dietary supplement: Cumin tea; Dietary supplement: Ginger Tea; Dietary supplement: Lemon Peel Tea; Dietary supplement: Functional Tea

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

• Study Type: Interventional
• Enrollment (Actual): 330
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • University of Lahore Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional therapy group; Control group on Carbohydrate Controlled Diet with conventional therapy	Dietary supplement: Conventional therapy; A carbohydrate-controlled diet focuses on limiting refined carbohydrates and sugars and total carbohydrate restriction to 50-70gm per major meal.
Experimental: Cumin tea group; Intervention with Carbohydrate Controlled Diet along with Cumin Seeds Tea	Dietary supplement: Cumin 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.
Experimental: Ginger Tea Group; Intervention with Carbohydrate Controlled Diet along with Ginger Tea	Dietary supplement: Ginger 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.
Experimental: Lemon Peel Tea Group; Intervention with Carbohydrate Controlled Diet along with Lemon Peel Tea	Dietary supplement: Lemon 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.
Experimental: Functional tea Group; : Intervention with Carbohydrate Controlled Diet along with Functional Tea	Dietary supplement: Functional 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Waist Circumference	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 )	60 days
Serum Triglyceride Level	Change in serum Triglyceride Level were monitored before and after the trial	60 days
Serum HDL- Cholesterol Level	Change in Levels were monitored before and after the trial	60 days
Fasting Glucose Level	Change in readings were monitored before and after the trial	60 days
Blood Pressure (Systolic and Diastolic)	Change in readings were monitored before and after the trial	60 days

Collaborators and Investigators

• Sponsor: University of Lahore
• Investigators: Principal Investigator: Maria Aslam, University of Lahore

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2021
• Primary Completion (Actual): July 11, 2021
• Study Completion (Actual): November 20, 2021

Study Registration Dates

• First Submitted: December 6, 2024
• First Submitted That Met QC Criteria: December 6, 2024
• First Posted (Actual): December 11, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Disease; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: IRB-UOL-FAHS/808/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be shared in the form of research articles without the personal information of the participant

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No