Stingless Bee Honey Augmentation in Major Depressive Disorders

The Effect of Stingless Bee Honey on BDNF, Oxidative Stress, Depressive Symptoms and Verbal Learning and Memory in Major Depressive Disorders: A Randomized Clinical Trial

The goal of this clinical trial is to learn if stingless bee honey can be an augmentation supplement in Major Depressive Disorder (MDD) in adults. It will also learn about the adverse effects of the honey. The main questions it aims to answer are:

1. Is there any effect of SBH on depressive symptoms between intervention and control groups in MDD?
2. Are there any effects of SBH on BDNF between intervention and control groups in MDD?
3. Are there any effects of SBH on oxidative stress between intervention and control groups in MDD?
4. Are there any effects of SBH on verbal learning and memory between intervention and control groups in MDD?

There is no placebo.

Participants will:

Take stingless bee honey or nothing every day for 2 months Visit the clinic once every 4 weeks for checkups and tests Report adherence and adverse effects of stingless bee honey on a self-reported online questionnaires

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder (MDD)
• Intervention / Treatment: Dietary supplement: stingless bee honey

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Kelantan
    • Kubang Kerian, Kelantan, Malaysia, 16150
      • Hospital Universiti Sains Malaysia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults with ages 18 to 65
• with Major Depressive Disorder with scores of Beck Depression Inventory Malay version equal or more than 11

Exclusion Criteria:

• Women in pregnancy or breast-feeding.
• Patients who with honey allergy or stingless bee honey allergy.
• Currently taking honey not limited to stingless bee honey or taken honey not limited to stingless bee honey in the past one month.
• comorbidity either with generalized anxiety disorder,
• panic disorder,
• social anxiety disorder,
• bipolar disorder,
• substance-use disorder,
• suicidal ideation or attempt,
• dementia,
• Alzheimer disease,
• diabetic,
• hypertension,
• chronic kidney disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention group; The participants under intervention group will receive stingless bee honey. At the same time, they will continue treatment as usual, their pharmacological like antidepressants or psychotherapy	Dietary supplement: stingless bee honey; Participants under intervention group will receive 20g of stingless bee honey in a packet form but participants under control group will not receive any stingless bee honey
No Intervention: Control group; The participants in the control group will not receive stingless bee honey. They will continue treatment as usual, their pharmacological like antidepressants or psychotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive symptoms	Depressive symptoms will be assessed using Beck Depression Inventory Malay-version questionnaire, For total score, no depression (1 - 10); mild to moderate (11 -20); moderate to severe (21 - 30); severe (31 - 40); very severe (41 - 63).	Before intervention, at week 4 during the intervention, at week 8 of the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxidative stress	Serum malondialdehyde concentrations in blood will be assessed	Before intervention, at week 4 during the intervention, at week 8 of the intervention
Brain derived neurotrophic factors, BDNF	Serum BDNF concentrations of blood will be assessed	Before intervention, at week 4 during the intervention, at week 8 of the intervention
Verbal learning and memory	Verbal learning and memory will be assessed using Malay version of auditory verbal learning test. The highest of total learning (sum of A1-A5 trial) is 75 score which one words = 1 score and the highest for delayed memory (A7 trial) is 15 score	Before intervention, at week 4 during the intervention, at week 8 of the intervention
Serum Interleukin-6	Serum IL-6 concentrations of blood will be measured using Elisa kit	Before intervention, at week 4 during the intervention, at week 8 of the intervention

Collaborators and Investigators

• Sponsor: Hospital Universiti Sains Malaysia
• Collaborators: Government of Malaysia
• Investigators: Study Director: Sharifah Zubaidiah, Universiti Sains Malaysia; Study Director: Mohd Zulkifli Mustafa, Universiti Sains Malaysia

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2024
• Primary Completion (Actual): August 10, 2025
• Study Completion (Actual): August 10, 2025

Study Registration Dates

• First Submitted: December 4, 2024
• First Submitted That Met QC Criteria: December 6, 2024
• First Posted (Actual): December 9, 2024

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: USM/JEPeM/KK/24020180; TCTR20240621001 (Registry Identifier: Thai Clinical Trials Registry)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Raw unprocessed data, without any identifier that could identify patients as individual person such as demographics chacteristics, baseline, week 4 and week 8 primary and secondary outcomes will be shared upon request by others

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No