Alteration of Sweet Taste Perception After Reduction of Sweet Food and Beverage Consumption.

Alteration of Sweet Taste Perception After 50% Reduction of Sweet Food and Beverage Consumption for 12 Weeks, Compared With Unmodified Diet.

The goal of this clinical trial is to determine whether reducing sugar intake by 50% for 12 weeks can change sweet taste perception in healthy adults and its consequences. The main questions it aims to answer are:

• Does sweet intensity change after reducing daily sugar intake by 50% for 12 weeks?
• How does sweet intensity change after completing dietary modification for 8 weeks?
• Does individual daily sugar intake change after completing dietary modification for 8 weeks?

Researchers will compare reducing daily sugar intake by 50% for 12 weeks to an unmodified diet to see if sugar reduction can change sweet intensity.

Participants will:

• Reduce daily sugar intake by 50% or maintain an unmodified diet for 12 weeks.
• Visit the clinic three times for anthropometric measurements, sweet perception tests, and to complete questionnaires.
• Keep a diet record for a total of 15 days during the research period.

Study Overview

• Status: Enrolling by invitation
• Conditions: Health-Related Behavior
• Intervention / Treatment: Behavioral: 50% sugar reduction

• Study Type: Interventional
• Enrollment (Estimated): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Bangkoknoi, Bangkok, Thailand, 10700
      • Faculty of Medicine Siriraj Hospital, Mahidol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• People with a fasting blood sugar level below 126 mg/dL or an HbA1C below 6.5% in the past 6 months, who are not currently being treated for diabetes.
• People who score 10 or more points on the sweet food consumption behavior questionnaire.
• People who are able to communicate in the Thai language.
• People who are able to chat and use video calls via the Line application.
• People who agree to modify their diet and beverages according to the recommendations of a dietitian.
• People who agree to undergo sweet taste testing, complete a food record, and fill out a questionnaire.

Exclusion Criteria:

• People with uncontrolled chronic conditions who have had changes in their treatment within the past 3 months.
• People with a history of severe illness in the past 6 months.
• People who regularly use medication, excluding contraceptives and vitamins.
• Pregnant women.
• People who have experienced a weight change of at least 10% over the past 3 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 50% sugar reduction; Participants were advised by a dietitian to reduce their daily caloric intake from sugars by 50% for 12 weeks.	Behavioral: 50% sugar reduction; Participants were advised by a dietitian to reduce their daily caloric intake from sugars by 50% for 12 weeks.
No Intervention: unmodified diet; Participants maintained an unmodified diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sweet intensity change from baseline after 12 weeks of the intervention.	Percentage of participants whose sweet intensity has increased after reducing daily sugar intake by 50% for 12 weeks, compared to those with an unmodified diet.	16 weeks from baseline (12 weeks after the start of the intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sweet intensity change from baseline after completing the intervention for 8 weeks.	Percentage of participants whose sweet intensity increased after completing dietary modification for 8 weeks, compared to those with an unmodified diet.	24 weeks from baseline
Changes in sugar consumption behavior from baseline	The average daily caloric intake from sugars after completing dietary modification for 8 weeks, compared to before the dietary change.	24 weeks from baseline

Collaborators and Investigators

• Sponsor: Mahidol University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: November 6, 2024
• First Submitted That Met QC Criteria: November 6, 2024
• First Posted (Estimated): November 7, 2024

Study Record Updates

• Last Update Posted (Estimated): November 7, 2024
• Last Update Submitted That Met QC Criteria: November 6, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: dietary modification; sweet taste perception; sugar reduction; dietary behavior; sweet intensity
• Other Study ID Numbers: 233/2567 (IRB1)

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