Amelioration of Lipid Profile Through Date Cider-vinegar Along With 5:2 Intermittent Fasting Among Prediabetic Individuals
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 108
- Locations
- 1
- Primary Endpoint
- Body Mass Index
Study Overview
Brief Summary
A common metabolic abnormality in hyperglycemic individuals, dyslipidemia is strongly linked to an increased risk of cardiovascular illness. This study looked at how date cider vinegar and 5:2 intermittent fasting affected the lipid profile and metabolic indices of hyperglycemic patients
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Control Group (T 0 ) (Drug)
Experimental Group (T 1 )
Participants received Date Cider Vinegar (DCV) for a duration of 3 months.
Intervention: Experimental Group (T 1 ) (Dietary Supplement)
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.
Intervention: Experimental Group (T 2 ) (Combination Product)
Outcomes
Primary Outcomes
Body Mass Index
Time Frame: 3 months
BMI was calculated by dividing weight (in kg) by the square of height (in meters).
Secondary Outcomes
- Blood pressure(3 months)
- Lipid Profile(3 months)
Investigators
Maria Aslam
Clinical Head
University of Lahore