The Effect of Oral Use of Lyophilised Royal Jelly on Cognitive Functions and Immune System in Elderly Individuals

Medipol University

Status: Not yet enrolling

Conditions: Cognitive Change

Treatments: Dietary Supplement: Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement 1000 mg/day; Other: Plasebo; Dietary Supplement: Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement 1500 mg/day; Dietary Supplement: Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement 500 mg/day

Study type: Interventional

Funder types: Other

Identifiers

NCT06404203

E-95961207-604.01.01-5745

Details and patient eligibility

About

Dementia is a significant public health problem, affecting 47 million people worldwide in 2015, according to World Health Organization data. It is expected to increase to 75 million in 2030 and reach 132 million in 2050.

Royal jelly is used as a supplement in treating of cancer, hypertension, diabetes and neurodegenerative diseases due to its antioxidant, anti-inflammatory, neuroprotective, cardioprotective, anti-proliferative and anti-fatigue properties. There are preclinical studies on the curative and protective effects of royal jelly on cognitive functions.

This randomized controlled, double-blind clinical trial is aimed to study the effect of oral use of lyophilized royal jelly for 4 weeks on immune system cytokine levels and cognitive functions in individuals aged 50-80 years without any neurological disease diagnosis.

Primary outcome measures are the Mini-Mental State Examination, the Alzheimer's Disease Assessment Scale-Cognitive Subscale, and the Geriatric Depression Scale.

Secondary outcome measures are serum interleukin-1β, interleukin-6, interleukin-10, tumor necrosis factor-α and transforming growth factor-β levels.

Full description

Volunteers who apply to Bağcılar Medipol Mega University Hospital Neurology Polyclinic will be recruited, and their demographic information will be recorded.

Volunteers who meet eligibility criteria will be randomly divided into three groups considering age groups (50-64 years old and 65-80 years old).

Primary and secondary outcome measures will be evaluated in volunteers. The results obtained will be recorded.

Diet recommendations will be made to the volunteers for four weeks. The products detailed in the protocol will be used by the volunteers orally for four weeks on an empty stomach in the morning.

Primary and secondary outcome measures will be reassessed in volunteers on day 28. The results obtained will be recorded.

Obtained results will be evaluated statistically.

Enrollment: 120 estimated patients

Sex: All

Ages: 55 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Between the ages of 55 and 70,
• Male or female,

Exclusion criteria

• History of allergy to bee products
• Known history of lactose allergy
• Diagnosed dementia,
• MMSE score below 21,
• ADAS-Cog score of 12 and above,
• Body Mass Index of 35 and above,
• Be taking any medical medication, herbal product or dietary supplement for dementia, except for those who stopped using it at least 1 month before inclusion in our study,
• Being or having been treated for acute acquired brain injuries such as acute traumatic brain injury, acute onset stroke,
• Being followed up due to inflammatory disease,
• Diagnosis of chronic or acute infection,
• Taking corticosteroids or non-steroidal anti-inflammatory drugs,
• Being or having been treated for a psychotic illness,
• Severe anaemia, vital organ dysfunction or critical illness.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 4 patient groups, including a placebo group

Royal Jelly 500 mg

Experimental group

Description:

30 volunteer

Treatment:

Dietary Supplement: Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement 500 mg/day

Royal Jelly 1000 mg

Experimental group

Description:

30 volunteer

Treatment:

Dietary Supplement: Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement 1000 mg/day

Royal Jelly 1500 mg

Experimental group

Description:

30 volunteer

Treatment:

Dietary Supplement: Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement 1500 mg/day

Placebo

Placebo Comparator group

Description:

30 volunteer

Treatment:

Other: Plasebo