Lipid ProfileSYMBIONICNCT06893991
The Effect of Symbiotic Beverage Consumption on Lipid Profile
A study testing SYMBIONIC and Dietary advice in people with Lipid Profile and Fasting Blood Sugar Above Normal, run by Politeknik Kesehatan Kemenkes Padang at 1 site in Indonesia.
Trial summary
The goal of this clinical trial is to evaluate whether the synbiotic beverage "Daygurt" can improve lipid profiles, blood sugar levels, blood pressure, and body weight in individuals diagnosed with dyslipidemia. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Lipid Profile, Fasting Blood Sugar Above Normal, Body Mass Index
- What is being tested?
- SYMBIONIC and Dietary advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndonesia
- Study dates
- 27 Feb 2025to 15 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Cholesterol total above 200 mg/dl, or LDL Cholesterol above 100, or BMI above 25 kg/m2
- Agree to study protocols
Who cannot join
- Has Allergic to dairy product
- Having any drug lowering cholesterol
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Health Ministry Polytechnic of Padang
Padang, West Sumatra, 25146
About this study
Official title: The Effect of Symbiotic Beverage Consumption on Lipid Profile and Nutritional Status in Overweight and Hypercholesterolemia Adults Aged Above 18 Years
The goal of this clinical trial is to evaluate whether the synbiotic beverage "Daygurt" can improve lipid profiles, blood sugar levels, blood pressure, and body weight in individuals diagnosed with dyslipidemia. The main questions it aims to answer are:
Does "Daygurt" significantly reduce total cholesterol and LDL levels compared to nutrition counseling alone? Does "Daygurt" increase HDL levels and reduce triglycerides more effectively than nutrition counseling? Does "Daygurt" lead to greater improvements in fasting blood sugar, blood pressure, and body weight compared to nutrition counseling?
Read more
The intervention group (receiving "Daygurt" plus nutrition counseling) will be compared to the comparison group (receiving nutrition counseling without "Daygurt") to see if "Daygurt" provides additional benefits beyond standard dietary advice.
Participants will be divided into 2 groups:
Intervention group: Consume "Daygurt" daily for 8 weeks. Comparison group: Receive nutrition counseling sessions focused on managing dyslipidemia but will not consume "Daygurt."
Both groups will undergo health parameter measurements before and after the intervention, including:
Total cholesterol, LDL, HDL, and triglyceride levels. Fasting blood sugar. Blood pressure. Body mass index (BMI).
- Being tested
- SYMBIONIC, Dietary advice
- Keywords
- Symbiotic Beverages, Lipid Profile, Body Mass Index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYMBIONICDietary supplement
Provision of 100 ml symbiotic beverages "daygurt" per day for 6 weeks, plus standard dietary advice for dyslipidemia
Dietary adviceBehavioural
Participants get standard dietary advice for dyslipidemia
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Consuming 100 ml Symbiotic beverages every day for 6 weeks plus dietary advice to overcome dyslipidemia Receives: Dietary Supplement: SYMBIONIC; Behavioral: Dietary advice |
| Comparison group | Active comparator | Receiving standard dietary advice to overcome dyslipidemia, but without drinking symbiotic beverage Receives: Behavioral: Dietary advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid profile
Fasting Total blood cholesterol, LDL cholesterol, HDL cholesterol and triglyceride level measured before and after intervention phase
Measured: 6 weeks (before and after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start27 Feb 2025
- Primary completion15 Jun 2025 (estimated)
- Study completion15 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lipid ProfileStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This trial is a controlled clinical studies conducted to evaluate the effectiveness of the symbiotic drink for improving lipid profiles, blood sugar and nutritional status in participants with hypercholesterolemia or overweight under study and to determine the common short-term side effects and risks.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Politeknik Kesehatan Kemenkes Padang
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gusnedi, Politeknik Kesehatan Kemenkes Padang
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06893991
- Sponsor's protocol ID
- PoliteknikKKP
- Acronym
- SYMBIONIC
- Status last verified
- Mar 2025
- First submitted
- 5 Mar 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Symbiotic Beverage Consumption on Lipid Profile and Nutritional Status in Overweight and Hypercholesterolemia Adults Aged Above 18 Years
- ClinicalTrials.gov ID
- NCT06893991
- Acronym / sponsor ID
- SYMBIONIC / PoliteknikKKP
- Keywords
- Symbiotic Beverages, Lipid Profile, Body Mass Index
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Politeknik Kesehatan Kemenkes PadangUniversity, hospital or other
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 15 Oct 2025 (estimated)
- First posted
- 25 Mar 2025 (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.
The goal of this clinical trial is to evaluate whether the synbiotic beverage "Daygurt" can improve lipid profiles, blood sugar levels, blood pressure, and body weight in individuals diagnosed with dyslipidemia. The main questions it aims to answer are:
Does "Daygurt" significantly reduce total cholesterol and LDL levels compared to nutrition counseling alone? Does "Daygurt" increase HDL levels and reduce triglycerides more effectively than nutrition counseling? Does "Daygurt" lead to greater improvements in fasting blood sugar, blood pressure, and body weight compared to nutrition counseling?
The intervention group (receiving "Daygurt" plus nutrition counseling) will be compared to the comparison group (receiving nutrition counseling without "Daygurt") to see if "Daygurt" provides additional benefits beyond standard dietary advice.
Participants will be divided into 2 groups:
Intervention group: Consume "Daygurt" daily for 8 weeks. Comparison group: Receive nutrition counseling sessions focused on managing dyslipidemia but will not consume "Daygurt."
Both groups will undergo health parameter measurements before and after the intervention, including:
Total cholesterol, LDL, HDL, and triglyceride levels. Fasting blood sugar. Blood pressure. Body mass index (BMI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This trial is a controlled clinical studies conducted to evaluate the effectiveness of the symbiotic drink for improving lipid profiles, blood sugar and nutritional status in participants with hypercholesterolemia or overweight under study and to determine the common short-term side effects and risks.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Dietary Supplement: SYMBIONIC, Behavioral: Dietary adviceConsuming 100 ml Symbiotic beverages every day for 6 weeks plus dietary advice to overcome dyslipidemia |
| Comparison group | Active comparator | Behavioral: Dietary adviceReceiving standard dietary advice to overcome dyslipidemia, but without drinking symbiotic beverage |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Cholesterol total above 200 mg/dl, or LDL Cholesterol above 100, or BMI above 25 kg/m2
- Agree to study protocols
Key exclusion criteria (2 listed)
- Has Allergic to dairy product
- Having any drug lowering cholesterol
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 |
|---|---|---|
| SYMBIONICProvision of 100 ml symbiotic beverages "daygurt" per day for 6 weeks, plus standard dietary advice for dyslipidemia | Dietary supplement | Intervention Group |
| Dietary adviceParticipants get standard dietary advice for dyslipidemia | Behavioural | Comparison group, Intervention Group |
Primary outcome
Lipid profile
Time frame: 6 weeks (before and after intervention)
Fasting Total blood cholesterol, LDL cholesterol, HDL cholesterol and triglyceride level measured before and after intervention phase
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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 SYMBIONIC and Dietary advice in people with Lipid Profile and Fasting Blood Sugar Above Normal, run by Politeknik Kesehatan Kemenkes Padang at 1 site in Indonesia.
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 2 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: under way, not looking for participants, as of the sponsor's last update on 25 Mar 2025. 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 Indonesia. 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?
This study is still under way. Results are not available in the source record yet.
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?
Lipid profile (time frame: 6 weeks (before and after intervention)). 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 25 Mar 2025.