Metabolic SyndromeNCT05956106
Effect of Mulberry Fruit Powder in Metabolic Syndrome
A study testing Black Mulberry Fruit Powder in people with Metabolic Syndrome, run by University of Veterinary and Animal Sciences, Lahore - Pakistan at 1 site in Pakistan.
Trial summary
Metabolic syndrome is a raising concern globally, especially in developing countries such as Pakistan. To prevent its risk factors diet and lifestyle modification is major solution. Functional foods have additional benefits of treating disease while providing basic nutrients. Read more about this study
- Who is it for?
- Ages 35 to 50 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Black Mulberry Fruit Powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2023to 1 Dec 2023
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects having fasting total cholesterol level of ≥ 200 mg/dl or LDL cholesterol ≥ 130 mg/dl.
- Fasting Blood Glucose ≥110mg/dl.
- SBP ≥ 130/ ≥ 85 mmHg
- Waist Circumference of ≥40 inches in males and ≥35 inches for females
Who cannot join
- Participants of age 55 or above
- Participants who have less than two risk factors
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Shan Medicare Hospital
Arifwala, Punjab Province, 57450
Dr. Muhammad Illyas, FCPS, +923075055198
About this study
Official title: Therapeutic Effect of Mulberry Fruit Powder Consumption in Metabolic Syndrome
Metabolic syndrome is a raising concern globally, especially in developing countries such as Pakistan. To prevent its risk factors diet and lifestyle modification is major solution. Functional foods have additional benefits of treating disease while providing basic nutrients. Mulberry is a native fruit with the properties of functional food, it is rich in anthocyanin and different anti-obesity,anti-diabetic, and anti-hyperlipidemic treating potential antioxidants. Mulberry will prove its therapeutic potential against the risk factors of metabolic syndrome.
Read the detailed description
Metabolic syndrome, which is characterized by a number of concurrent risk factors. These risk factors include dysglycemia, high blood pressure, high triglyceride levels, low levels of HDL cholesterol, and obesity (particularly central adiposity). It is rapidly increasing the burden of non-communicable diseases (NCDs) in Pakistan. The prevalence of MetS in Pakistan is 28.6%, and suburban areas from the province of Punjab showed a high prevalence. Females are more prone to metabolic syndrome. Dietary and lifestyle modification can prevent MetS from converting into CVD, T2DM, and stroke. There is limited documented research in Pakistan related to the therapeutic roles of mulberry fruit powder. With respect to these limitations, the present study aims to assess the therapeutic roles of mulberry fruit powder consumption on metabolic syndrome.
The utilization of dried mulberry fruit powder (MFP) as a component of nutritional supplementation will effectively ameliorate the clinical markers associated with metabolic syndrome.
- Conditions
- Metabolic Syndrome
- Being tested
- Black Mulberry Fruit Powder
- Keywords
- Hypertension, Diabetes, Obesity, Hyperlipidemia, Mulberry, Anthocyanin
- Medical subject headings
- Metabolic Syndrome, Hypertension, Diabetes Mellitus, Obesity, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Black Mulberry Fruit PowderDietary supplement
Also called Morus Nigra
Anthocyanin plays a major role in preventing symptoms of metabolic syndrome.
| Study group | Role | What they receive |
|---|---|---|
| Metabolic syndrome patients | Experimental | Dried Mulberry fruit powder is used for preventing symptoms in Metabolic Syndrome patients Dietary intervention: Black Mulberry fruit powder Dosage: 45g per day Receives: Dietary Supplement: Black Mulberry Fruit Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid profile will be assessed before and after the trial.
The change in lipid profile, after consuming mulberry fruit powder for 45 days, will be assessed. The value will be closed to optimized values.
Measured: 45 days
Fasting glucose level will be assessed before and after the trial
The change in fasting glucose levels will be assessed after consuming mulberry fruit powder for 45 days.The values will be become close to optimized levels
Measured: 45 days
Weight circumference will be measured before and after the trial
The change in weight will be measured after consuming mulberry fruit powder for 45 days.The value will be close to normal range.
Measured: 45 days
Blood pressure will be assessed before and after the trial.
The change in systolic and diastolic blood pressure, after consuming mulberry fruit powder for 45 days. The values will become close to optimized levels.
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start1 Aug 2023
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
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.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Case-Control Study
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Veterinary and Animal Sciences, Lahore - Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asif Ali, University of Veterinary and Animal Sciences, Lahore - Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05956106
- Sponsor's protocol ID
- Mulberry Fruit Powder
- Status last verified
- Nov 2023
- First submitted
- 13 Jul 2023
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All available data will be confidential
Publications
Wan M, Li Q, Lei Q, Zhou D, Wang S. Polyphenols and Polysaccharides from Morus alba L. Fruit Attenuate High-Fat Diet-Induced Metabolic Syndrome Modifying the Gut Microbiota and Metabolite Profile. Foods. 2022 Jun 20;11(12):1818. doi: 10.3390/foods11121818.
PubMed 35742014
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effect of Mulberry Fruit Powder Consumption in Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT05956106
- Acronym / sponsor ID
- Mulberry Fruit Powder
- Conditions
- Metabolic Syndrome
- Keywords
- Hypertension, Diabetes, Obesity, Hyperlipidemia, Mulberry, Anthocyanin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Veterinary and Animal Sciences, Lahore - PakistanUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 21 Jul 2023 (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.
Metabolic syndrome is a raising concern globally, especially in developing countries such as Pakistan. To prevent its risk factors diet and lifestyle modification is major solution. Functional foods have additional benefits of treating disease while providing basic nutrients. Mulberry is a native fruit with the properties of functional food, it is rich in anthocyanin and different anti-obesity,anti-diabetic, and anti-hyperlipidemic treating potential antioxidants. Mulberry will prove its therapeutic potential against the risk factors of metabolic syndrome.
Detailed description
Metabolic syndrome, which is characterized by a number of concurrent risk factors. These risk factors include dysglycemia, high blood pressure, high triglyceride levels, low levels of HDL cholesterol, and obesity (particularly central adiposity). It is rapidly increasing the burden of non-communicable diseases (NCDs) in Pakistan. The prevalence of MetS in Pakistan is 28.6%, and suburban areas from the province of Punjab showed a high prevalence. Females are more prone to metabolic syndrome. Dietary and lifestyle modification can prevent MetS from converting into CVD, T2DM, and stroke. There is limited documented research in Pakistan related to the therapeutic roles of mulberry fruit powder. With respect to these limitations, the present study aims to assess the therapeutic roles of mulberry fruit powder consumption on metabolic syndrome.
The utilization of dried mulberry fruit powder (MFP) as a component of nutritional supplementation will effectively ameliorate the clinical markers associated with metabolic syndrome.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Case-Control Study
| Arm | Type | Receives |
|---|---|---|
| Metabolic syndrome patients | Experimental | Dietary Supplement: Black Mulberry Fruit PowderDried Mulberry fruit powder is used for preventing symptoms in Metabolic Syndrome patients Dietary intervention: Black Mulberry fruit powder Dosage: 45g per day |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects having fasting total cholesterol level of ≥ 200 mg/dl or LDL cholesterol ≥ 130 mg/dl.
- Fasting Blood Glucose ≥110mg/dl.
- SBP ≥ 130/ ≥ 85 mmHg
- Waist Circumference of ≥40 inches in males and ≥35 inches for females
Key exclusion criteria (2 listed)
- Participants of age 55 or above
- Participants who have less than two risk factors
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 |
|---|---|---|
| Black Mulberry Fruit PowderAlso: Morus NigraAnthocyanin plays a major role in preventing symptoms of metabolic syndrome. | Dietary supplement | Metabolic syndrome patients |
Primary outcome
Lipid profile will be assessed before and after the trial.
Time frame: 45 days
The change in lipid profile, after consuming mulberry fruit powder for 45 days, will be assessed. The value will be closed to optimized values.
Fasting glucose level will be assessed before and after the trial
Time frame: 45 days
The change in fasting glucose levels will be assessed after consuming mulberry fruit powder for 45 days.The values will be become close to optimized levels
Weight circumference will be measured before and after the trial
Time frame: 45 days
The change in weight will be measured after consuming mulberry fruit powder for 45 days.The value will be close to normal range.
Blood pressure will be assessed before and after the trial.
Time frame: 45 days
The change in systolic and diastolic blood pressure, after consuming mulberry fruit powder for 45 days. The values will become close to optimized levels.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
- Results publication: PubMed 35742014Wan M, Li Q, Lei Q, Zhou D, Wang S. Polyphenols and Polysaccharides from Morus alba L. Fruit Attenuate High-Fat Diet-Induced Metabolic Syndrome Modifying the Gut Microbiota and Metabolite Profile. Foods. 2022 Jun 20;11(12):1818. doi: 10.3390/foods11121818.
- Polyphenols and Polysaccharides from Morus alba L. Fruit Attenuate High-Fat Diet-Induced Metabolic SyndromeLink provided by the sponsor.
- Individual participant dataSharing planned: No. All available data will be confidential
Related trials for Metabolic Syndrome
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Black Mulberry Fruit Powder in people with Metabolic Syndrome, run by University of Veterinary and Animal Sciences, Lahore - Pakistan 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 3 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fiza Maqbool, DNS (03008077414, fizach65@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipid profile will be assessed before and after the trial. (time frame: 45 days). The study lists 4 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 NCT05956106, 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 3 Nov 2023.