- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07627555
Polyunsaturated Fatty Acids-based Bars Effect on Metabolic Syndrome Patients
Effects of Polyunsaturated Fatty Acids-based Bars on Lipid Profile Among Patients With Metabolic Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study was conducted at Chaudhry Muhammad Akram Teaching & Research Hospital, Lahore. Total 60 individuals diagnosed with metabolic syndrome, like deranged lipid profile, high blood pressure (ranges mild to moderate), and elevated levels of HbA1c (5.6%-6.4%), aged between 40 to 65 years were part of the study. The participants were randomly selected and divided into two groups.
Control group (T 0 ) was given one jelly candy as mid-morning snack. The experimental group (T 1 ) was given PUFA bar one each daily The follow-up for patients has been conducted monthly, all laboratory test (blood pressure, lipid profile, HbA1c and CRP) has been done on 1st and after 8 weeks. The baseline and post-test study data is compared to test the study hypothesis.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lahore, Pakistan
- University of Lahore
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Metabolic syndrome patient's age 40 to 65 years with BMI (above 25 kg/m 2 ) was major part of this study.
- Patients having Triglyceride levels range from mild to moderate (150 to 499 mg/dL) are included in the study.
- Patients having LDL (Low density lipoprotein) range from mild (130-159 mg/dL) to moderate (160-189 mg/dL) are included in the study.
- Patients having HDL (High-density lipoprotein) range from mild to moderate (60 mg/dL or higher) have been included in the study.
Exclusion Criteria:
- Lactating and pregnant women will not be included.
- Patients who are using any kind of medicine.
- Any person allergic to nuts.
- Adults suffering from critical health conditions, including cancer.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Control group T0
participants have taken one jelly candy as a mid-morning snack for a duration of 2 months.
|
participants were advised to take one jelly candy as a mid-morning snack for a duration of 2 months.
|
|
Experimental: Experimental group T1
participants have taken one PUFA bar as a mid- morning snack for a duration of 2 months.
|
Participants were advised to taken one PUFA bar as a mid- morning snack for a duration of 2 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Mass Index
Time Frame: 60 days
|
BMI is defined as body weight in kilograms divided by height in meters squared (kg/m²).
BMI cut-off points are used to assess weight status, categorizing individuals as underweight, normal, overweight or obese.
Obesity is further classified into grades 1, 2 and 3.
|
60 days
|
|
Lipid Profile
Time Frame: 60 days
|
Total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C) and triglycerides levels were measured.
|
60 days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-UOL-FAHS/570/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dyslipidemia
-
Chong Kun Dang PharmaceuticalCompletedDyslipidemia (Fredrickson Type Ⅱa) | Dyslipidemia (Fredrickson Type Ⅱb)Korea, Republic of
-
Kowa Research Institute, Inc.CompletedMixed Dyslipidemia | Primary DyslipidemiaUnited States
-
Fundación del Caribe para la Investigación BiomédicaNaturmegaNot yet recruitingMixed DyslipidemiaColombia
-
Addpharma Inc.Not yet recruitingMixed DyslipidemiaSouth Korea
-
Daewon Pharmaceutical Co., Ltd.Completed
-
Addpharma Inc.RecruitingMixed DyslipidemiaKorea, Republic of
-
Hanlim Pharm. Co., Ltd.RecruitingMixed DyslipidemiaKorea, Republic of
-
IlDong Pharmaceutical Co LtdNot yet recruiting
-
Arrowhead PharmaceuticalsCompletedMixed DyslipidemiaUnited States, Australia, Canada, Hungary, New Zealand, Poland
-
Shanghai Argo Biopharmaceutical Co., Ltd.Active, not recruiting
Clinical Trials on Jelly Candy
-
The Fourth Affiliated Hospital of Zhejiang University...RecruitingThin Endometrium | Diminished Ovarian Reserve (DOR)China
-
University Hospital, Basel, SwitzerlandCompletedXerostomia | Dryness of MouthSwitzerland
-
ChinaNormNu Skin EnterprisesCompletedMild to Moderate Sleep Disorder | PressureChina
-
TCI Co., Ltd.CompletedCardiovascular DiseasesChina
-
Taipei Medical UniversityTaiwan Otsuka Pharm. Co., LtdActive, not recruiting
-
Dental Innovation Foundation Under Royal PatronageMahidol University; Ministry of Health, Thailand; Srinakharinwirot UniversityCompletedQuality of Life | Head and Neck Neoplasms | Nutrition Related CancerThailand
-
TCI Co., Ltd.Completed
-
Universidade Federal FluminenseRecruitingInflammation | Systemic Arterial HypertensionBrazil
-
Shandong Sibote Biotechnology Co., Ltd.Completed
-
Showa Inan General HospitalCompleted