Diabete MellitusNCT07710898
Amelioration of Lipid Profile Through Date Cider-vinegar Along With 5:2 Intermittent Fasting
A study testing Experimental Group (T 1 ) and Experimental Group (T 2 ) in people with Diabete Mellitus and Prediabetes, run by University of Lahore at 1 site in Pakistan.
Trial 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 Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Diabete Mellitus, Prediabetes, Hyperlipidemia
- What is being tested?
- Experimental Group (T 1 ) and Experimental Group (T 2 )
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 sitePakistan
- Study dates
- 12 Jan 2026to 12 May 2026
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- Any Lactating and pregnant women were not included.
- Any person allergic to citric acid.
- Adults suffering from critical health conditions, including cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Amelioration of Lipid Profile Through Date Cider-vinegar Along With 5:2 Intermittent Fasting Among Prediabetic Individuals
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
Read the 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.
- Conditions
- Diabete Mellitus, Prediabetes, Hyperlipidemia
- Being tested
- Control Group (T 0 ), Experimental Group (T 1 ), Experimental Group (T 2 )
- Keywords
- Diabete Mellitus, Prediabetes, Hyperlipidemia, lipid profile, date- cider vinegar
- Medical subject headings
- Diabetes Mellitus, Prediabetic State, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control Group (T 0 )Drug
The control group received standard dietary advice without vinegar supplementation or fasting intervention.
Experimental Group (T 1 )Dietary supplement
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 Group (T 2 )Combination product
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group (T 0 ) | Active comparator | Participants continued their prescribed conventional medications for hyperglycemia and lipid management without any additional dietary or vinegar intervention for a duration of 3 months. Receives: Drug: Control Group (T 0 ) |
| Experimental Group (T 1 ) | Experimental | Participants received Date Cider Vinegar (DCV) for a duration of 3 months. Receives: Dietary Supplement: Experimental Group (T 1 ) |
| Experimental Group (T 2 ) | Experimental | Participants followed 5:2 Intermittent Fasting (two non-consecutive fasting days per week) along with DCV intervention for a duration of 3 months. Receives: Combination Product: Experimental Group (T 2 ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index
BMI was calculated by dividing weight (in kg) by the square of height (in meters).
Measured: 3 months
Secondary outcomes (2)
Blood pressure
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.
Measured: 3 months
Lipid Profile
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start12 Jan 2026
- Primary completion12 Apr 2026
- Study completion12 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete MellitusStudies 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
- Masking
- None (open label)
- Enrolment
- 108 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07710898
- Sponsor's protocol ID
- IRB-UOL-FAHS/573/2026
- Status last verified
- Jan 2026
- First submitted
- 14 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amelioration of Lipid Profile Through Date Cider-vinegar Along With 5:2 Intermittent Fasting Among Prediabetic Individuals
- ClinicalTrials.gov ID
- NCT07710898
- Acronym / sponsor ID
- IRB-UOL-FAHS/573/2026
- Conditions
- Diabete Mellitus, Prediabetes, Hyperlipidemia
- Keywords
- Diabete Mellitus, Prediabetes, Hyperlipidemia, lipid profile, date- cider vinegar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- 12 Apr 2026 (actual)
- Study completion
- 12 May 2026 (actual)
- First posted
- 17 Jul 2026 (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.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group (T 0 ) | Active comparator | Drug: 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. |
| Experimental Group (T 1 ) | Experimental | Dietary Supplement: Experimental Group (T 1 )Participants received Date Cider Vinegar (DCV) for a duration of 3 months. |
| Experimental Group (T 2 ) | Experimental | Combination Product: 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. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- Any Lactating and pregnant women were not included.
- Any person allergic to citric acid.
- Adults suffering from critical health conditions, including cancer.
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 |
|---|---|---|
| Control Group (T 0 )The control group received standard dietary advice without vinegar supplementation or fasting intervention. | Drug | Control Group (T 0 ) |
| Experimental Group (T 1 )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. | Dietary supplement | Experimental Group (T 1 ) |
| Experimental Group (T 2 )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. | Combination product | Experimental Group (T 2 ) |
Primary outcome
Body Mass Index
Time frame: 3 months
BMI was calculated by dividing weight (in kg) by the square of height (in meters).
2 secondary outcomes
Blood pressure
Time frame: 3 months
Lipid Profile
Time frame: 3 months
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 17 Jul 2026.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Group (T 1 ) and Experimental Group (T 2 ) in people with Diabete Mellitus and Prediabetes, 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 9 inclusion and 3 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 17 Jul 2026. 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?
Body Mass Index (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2026.