The Effect of Symbiotic Beverage Consumption on Lipid Profile (SYMBIONIC)

March 23, 2025 updated by: Gusnedi, Politeknik Kesehatan Kemenkes Padang

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?

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • West Sumatra
      • Padang, West Sumatra, Indonesia, 25146
        • Health Ministry Polytechnic of Padang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Cholesterol total above 200 mg/dl, or LDL Cholesterol above 100, or BMI above 25 kg/m2
  • Agree to study protocols

Exclusion Criteria:

  • Has Allergic to dairy product
  • Having any drug lowering cholesterol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Consuming 100 ml Symbiotic beverages every day for 6 weeks plus dietary advice to overcome dyslipidemia
Dietary supplement: SYMBIONIC
Provision of 100 ml symbiotic beverages "daygurt" per day for 6 weeks, plus standard dietary advice for dyslipidemia
Behavioral: Dietary advice
Participants get standard dietary advice for dyslipidemia
Active Comparator: Comparison group
Receiving standard dietary advice to overcome dyslipidemia, but without drinking symbiotic beverage
Behavioral: Dietary advice
Participants get standard dietary advice for dyslipidemia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 weeks (before and after intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Politeknik Kesehatan Kemenkes Padang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2025

Primary Completion (Estimated)

June 15, 2025

Study Completion (Estimated)

October 15, 2025

Study Registration Dates

First Submitted

March 5, 2025

First Submitted That Met QC Criteria

March 23, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 23, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PoliteknikKKP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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