Influence of Herbal Infusion on Metabolic Syndrome

NCT06728449 | Completed

• 1 other identifier: IRB-UOL-FAHS/808/2021
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (5)

• 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

• Blood Pressure (Systolic and Diastolic)

  Change in readings were monitored before and after the trial

  60 days

• Fasting Glucose Level

  Change in readings were monitored before and after the trial

  60 days

Study Arms (5)

Conventional therapy group

ACTIVE COMPARATOR

Control group on Carbohydrate Controlled Diet with conventional therapy

Dietary Supplement: Conventional therapy

Cumin tea group

EXPERIMENTAL

Intervention with Carbohydrate Controlled Diet along with Cumin Seeds Tea

Dietary Supplement: Cumin tea

Ginger Tea Group

EXPERIMENTAL

Intervention with Carbohydrate Controlled Diet along with Ginger Tea

Dietary Supplement: Ginger Tea

Lemon Peel Tea Group

EXPERIMENTAL

Intervention with Carbohydrate Controlled Diet along with Lemon Peel Tea

Dietary Supplement: Lemon Peel Tea

Functional tea Group

EXPERIMENTAL

: Intervention with Carbohydrate Controlled Diet along with Functional Tea

Dietary Supplement: Functional Tea

Interventions

Cumin tea DIETARY_SUPPLEMENT

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.

Cumin tea group

Ginger Tea DIETARY_SUPPLEMENT

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.

Ginger Tea Group

Lemon Peel Tea DIETARY_SUPPLEMENT

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.

Lemon Peel Tea Group

Functional Tea DIETARY_SUPPLEMENT

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.

Functional tea Group

Conventional therapy DIETARY_SUPPLEMENT

A carbohydrate-controlled diet focuses on limiting refined carbohydrates and sugars and total carbohydrate restriction to 50-70gm per major meal.

Conventional therapy group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

University of Lahore Teaching Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 27781121 BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Maria Aslam

  University of Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Double- Blinded
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maria Aslam

Model Details: 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.

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 11, 2024
• Study Start: March 7, 2021
• Primary Completion: July 11, 2021
• Study Completion: November 20, 2021
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)