Metabolic SyndromeNCT06728449
Influence of Herbal Infusion on Metabolic Syndrome
A study testing Cumin tea, Ginger Tea and Lemon Peel Tea in people with Metabolic Syndrome, run by University of Lahore at 1 site in Pakistan.
Trial summary
After taking written informed consent patients, the selected participants were divided into control and experimental group randomly. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Cumin tea, Ginger Tea and Lemon Peel Tea
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 sitePakistan
- Study dates
- 7 Mar 2021to 20 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
University of Lahore Teaching Hospital
Lahore, Punjab Province, 54000
About this study
Official title: 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.
Read the 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.
- 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.
- 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.
- Clinical Findings The metabolic syndrome patients were assessed clinically to have an insight into nutritional deficiencies on the bases of sign and symptoms.
- 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
- Conditions
- Metabolic Syndrome
- Being tested
- Cumin tea, Ginger Tea, Lemon Peel Tea, Functional Tea, Conventional therapy
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cumin teaDietary 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.
Ginger TeaDietary 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.
Lemon Peel TeaDietary 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.
Functional TeaDietary 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.
Conventional therapyDietary supplement
A carbohydrate-controlled diet focuses on limiting refined carbohydrates and sugars and total carbohydrate restriction to 50-70gm per major meal.
| Study group | Role | What they receive |
|---|---|---|
| Conventional therapy group | Active comparator | Control group on Carbohydrate Controlled Diet with conventional therapy Receives: Dietary Supplement: Conventional therapy |
| Cumin tea group | Experimental | Intervention with Carbohydrate Controlled Diet along with Cumin Seeds Tea Receives: Dietary Supplement: Cumin tea |
| Ginger Tea Group | Experimental | Intervention with Carbohydrate Controlled Diet along with Ginger Tea Receives: Dietary Supplement: Ginger Tea |
| Lemon Peel Tea Group | Experimental | Intervention with Carbohydrate Controlled Diet along with Lemon Peel Tea Receives: Dietary Supplement: Lemon Peel Tea |
| Functional tea Group | Experimental | : Intervention with Carbohydrate Controlled Diet along with Functional Tea Receives: Dietary Supplement: Functional Tea |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 )
Measured: 60 days
Serum Triglyceride Level
Change in serum Triglyceride Level were monitored before and after the trial
Measured: 60 days
Serum HDL- Cholesterol Level
Change in Levels were monitored before and after the trial
Measured: 60 days
Blood Pressure (Systolic and Diastolic)
Change in readings were monitored before and after the trial
Measured: 60 days
Fasting Glucose Level
Change in readings were monitored before and after the trial
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start7 Mar 2021
- Primary completion11 Jul 2021
- Study completion20 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Aslam, University of Lahore
- Investigators
- Maria Aslam, Principal investigator, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06728449
- Sponsor's protocol ID
- IRB-UOL-FAHS/808/2021
- Status last verified
- Dec 2024
- First submitted
- 6 Dec 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared in the form of research articles without the personal information of the participant
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.
PubMed 27781121
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Herbal Infusion of Cumin Seed, Ginger Root and Lemon Peel on Clinical Outcomes Among Patients With Hyperuricemia Associated Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT06728449
- Acronym / sponsor ID
- IRB-UOL-FAHS/808/2021
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 7 Mar 2021 (actual)
- Primary completion
- 11 Jul 2021 (actual)
- Study completion
- 20 Nov 2021 (actual)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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.
- Clinical Findings The metabolic syndrome patients were assessed clinically to have an insight into nutritional deficiencies on the bases of sign and symptoms.
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 5
- 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.
| Arm | Type | Receives |
|---|---|---|
| Conventional therapy group | Active comparator | Dietary Supplement: Conventional therapyControl group on Carbohydrate Controlled Diet with conventional therapy |
| Cumin tea group | Experimental | Dietary Supplement: Cumin teaIntervention with Carbohydrate Controlled Diet along with Cumin Seeds Tea |
| Ginger Tea Group | Experimental | Dietary Supplement: Ginger TeaIntervention with Carbohydrate Controlled Diet along with Ginger Tea |
| Lemon Peel Tea Group | Experimental | Dietary Supplement: Lemon Peel TeaIntervention with Carbohydrate Controlled Diet along with Lemon Peel Tea |
| Functional tea Group | Experimental | Dietary Supplement: Functional Tea: Intervention with Carbohydrate Controlled Diet along with Functional Tea |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cumin teaThe 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 supplement | Cumin tea group |
| Ginger TeaThe 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 supplement | Ginger Tea Group |
| Lemon Peel TeaThe 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 supplement | Lemon Peel Tea Group |
| Functional TeaThe 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 supplement | Functional tea Group |
| Conventional therapyA carbohydrate-controlled diet focuses on limiting refined carbohydrates and sugars and total carbohydrate restriction to 50-70gm per major meal. | Dietary supplement | Conventional therapy group |
Primary outcome
Waist Circumference
Time frame: 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
Time frame: 60 days
Change in serum Triglyceride Level were monitored before and after the trial
Serum HDL- Cholesterol Level
Time frame: 60 days
Change in Levels were monitored before and after the trial
Blood Pressure (Systolic and Diastolic)
Time frame: 60 days
Change in readings were monitored before and after the trial
Fasting Glucose Level
Time frame: 60 days
Change in readings were monitored before and after the trial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Background: PubMed 27781121Taghizadeh 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.
- Individual participant dataSharing planned: No. Data will be shared in the form of research articles without the personal information of the participant
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Aslam principal investigator
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cumin tea, Ginger Tea and Lemon Peel Tea in people with Metabolic Syndrome, run by University of Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Waist Circumference (time frame: 60 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06728449, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.