The Effect of Symbiotic Beverage Consumption on Lipid Profile

NCT06893991 | Active Not Recruiting DMC

• 1 other identifier: PoliteknikKKP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Lipid Profile; Fasting Blood Sugar Above Normal; Body Mass Index

Keywords

Symbiotic Beverages; Lipid Profile; Body Mass Index

Outcome Measures

Primary Outcomes (1)

• Lipid profile

  Fasting Total blood cholesterol, LDL cholesterol, HDL cholesterol and triglyceride level measured before and after intervention phase

  6 weeks (before and after intervention)

Study Arms (2)

Intervention Group

EXPERIMENTAL

Consuming 100 ml Symbiotic beverages every day for 6 weeks plus dietary advice to overcome dyslipidemia

Dietary Supplement: SYMBIONIC; Behavioral: Dietary advice

Comparison group

ACTIVE COMPARATOR

Receiving standard dietary advice to overcome dyslipidemia, but without drinking symbiotic beverage

Behavioral: Dietary advice

Interventions

SYMBIONIC DIETARY_SUPPLEMENT

Provision of 100 ml symbiotic beverages "daygurt" per day for 6 weeks, plus standard dietary advice for dyslipidemia

Intervention Group

Dietary advice BEHAVIORAL

Participants get standard dietary advice for dyslipidemia

Comparison group; Intervention Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Politeknik Kesehatan Kemenkes Padang: lead

Study Sites (1)

Health Ministry Polytechnic of Padang

Padang, West Sumatra, 25146, Indonesia

Location

MeSH Terms

Interventions

Nutrition Assessment

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Dr

Model Details: 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.

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 25, 2025
• Study Start: February 27, 2025
• Primary Completion: June 15, 2025
• Study Completion: October 15, 2025
• Last Updated: March 25, 2025

Record last verified: 2025-03

Locations

ID (1)