NCT06678386

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 6, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

November 7, 2024

Status Verified

November 1, 2024

Enrollment Period

6 months

First QC Date

November 6, 2024

Last Update Submit

November 6, 2024

Conditions

Keywords

sweet taste perceptionsugar reductiondietary behaviordietary modificationsweet intensity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Sweet intensity change from baseline after completing the intervention for 8 weeks.

    24 weeks from baseline

  • Changes in sugar consumption behavior from baseline

    24 weeks from baseline

Study Arms (2)

50% sugar reduction

EXPERIMENTAL

Participants were advised by a dietitian to reduce their daily caloric intake from sugars by 50% for 12 weeks.

Behavioral: 50% sugar reduction

unmodified diet

NO INTERVENTION

Participants maintained an unmodified diet.

Interventions

Participants were advised by a dietitian to reduce their daily caloric intake from sugars by 50% for 12 weeks.

50% sugar reduction

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkoknoi, Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2024

First Posted

November 7, 2024

Study Start

October 1, 2024

Primary Completion

March 31, 2025

Study Completion

July 31, 2025

Last Updated

November 7, 2024

Record last verified: 2024-11

Locations