- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07710898
Amelioration of Lipid Profile Through Date Cider-vinegar Along With 5:2 Intermittent Fasting
Amelioration of Lipid Profile Through Date Cider-vinegar Along With 5:2 Intermittent Fasting Among Prediabetic Individuals
Study Overview
Status
Conditions
Detailed Description
The target population was adults between the ages of 35 and 65 years who are receiving outpatient care at a hospital or clinic with a diagnosis of either mild to moderate hypertension, dyslipidemia or pre-diabetes. Once consent was given, participants were then be randomly assigned to receive the prescribed intervention or act as a control. The intervention period was 12 weeks.
Participants in the experimental groups received date cider vinegar supplementation, with one group additionally following the 5:2 intermittent fasting protocol. The control group received standard dietary advice without vinegar supplementation or fasting intervention. Participants were instructed to follow the assigned intervention daily according to the study protocol. Weekly follow-up visits were conducted to monitor dietary compliance, record self-reported adherence, and assess health outcomes including lipid profile, body weight,and blood pressure. Usual dietary intake was also monitored to ensure consistency and adherence to the intervention.
At baseline, nutritional assessment based on weight and height, BMI, waist circumference, blood pressure, fasting blood glucose, lipid panels (HDL, LDL, total cholesterol, triglycerides), and dietary intake analysis were done. After 12 weeks of intervention all the measurements that were done again to compare the results pre- and post-intervention.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lahore, Pakistan
- The University of Lahore
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- The inclusion criterion was target adults with both gender aged 35-65 years.
- Adults with a diagnosis of mild to moderate hypertension
- Mild hypertension (140-159/90-99 mm Hg)
- Moderate hypertension (160-179/100-109 mm Hg)
- Adults having mild to moderate alterations in lipid profile
- Triglycerides: 150 to 499 mg/dL
- LDL-C levels: Mild Alteration (130 to 159 mg/dL) and Moderate Alteration (160 to 189 mg/dL)
- Adults with pre-diabetes (hbA1c= 5.6-6.4%) were used.
- Patients were solicited from hospital.
Exclusion Criteria:
- Any Lactating and pregnant women were not included.
- Any person allergic to citric acid.
- 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 |
|---|---|
|
Active Comparator: Control Group (T 0 )
Participants continued their prescribed conventional medications for hyperglycemia and lipid management without any additional dietary or vinegar intervention for a duration of 3 months.
|
The control group received standard dietary advice without vinegar supplementation or fasting intervention.
|
|
Experimental: Experimental Group (T 1 )
Participants received Date Cider Vinegar (DCV) for a duration of 3 months.
|
Participants were advised to take 15 ml of Date Cider Vinegar (DCV) diluted in 1 cup (250ml) of water 15 minutes before breakfast and dinner daily for a duration of 3 months.
|
|
Experimental: Experimental Group (T 2 )
Participants followed 5:2 Intermittent Fasting (two non-consecutive fasting days per week) along with DCV intervention for a duration of 3 months.
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Participants were advised to follow 5:2 Intermittent Fasting (two non-consecutive fasting days per week) along with DCV intervention for a duration of 3 months. 15 ml of DCV was diluted in 1 cup of water and It was taken 15 minutes before breakfast and dinner daily. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Mass Index
Time Frame: 3 months
|
BMI was calculated by dividing weight (in kg) by the square of height (in meters).
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3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood pressure
Time Frame: 3 months
|
Blood pressure measurements will be taken using an automated sphygmomanometer, with systolic pressure and diastolic pressure being measured while sitting after a 5-minute rest.
The average of three readings were used for analysis.
|
3 months
|
|
Lipid Profile
Time Frame: 3 months
|
Total cholesterol, low-density lipoprotein cholesterol (LDL-C), triglycerides, and high-density lipoprotein cholesterol (HDL-C) levels were measured using enzymatic methods with commercial test kits.
|
3 months
|
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
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Metabolic Diseases
- Glucose Metabolism Disorders
- Dyslipidemias
- Lipid Metabolism Disorders
- Nutritional and Metabolic Diseases
- Diabetes Mellitus
- Prediabetic State
- Hyperlipidemias
- Investigative Techniques
- Epidemiologic Research Design
- Epidemiologic Methods
- Research Design
- Methods
- Control Groups
Other Study ID Numbers
- IRB-UOL-FAHS/573/2026
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.
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