Morning-Evening Specific Longevity Food Supplement

University of Primorska

Status and phase: Active, not recruiting; Phase 1

Conditions: Aging

Treatments: Dietary Supplement: Control; Dietary Supplement: Morning- and evening-specific compound food supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT07416396

PODSTUDIJA-dolgozivost

Details and patient eligibility

About

The use of food supplements with the aim of increasing longevity in the general population is rapidly increasing, while high-quality clinical evidence on the efficacy of comprehensive formulations and their impact on biomarkers of aging is lacking. The present clinical trial will evaluate the effects of selected morning- and evening-speciffic dietary supplement on longevity biomarkers in a selected population of healthy adults of both sexes between the ages of 50 and 70 and compare it to placebo. The main questions it answers are: Does the 6-month use of the longevity supplement impact the 6-months change in different markers for measuring biological age compared to placebo? The study will involve 60 subjects, of whom 30 will consume the morning- and evening-speciffic longevity food supplements and 30 will consume a placebo. The study will last 6 months. The subjects will will visit the Faculty four times: at the beginning of the study (background measurement), after one, three and six months of consuming the dietary supplement or placebo. At each visit, subjects will undergo anthropometric measurements, blood pressure measurements, and blood samples will be taken to determine baseline haematocrite, albumin, creatinine, alcaline phosphatase, lipid profile, glucose concentration, inflammatory parameters, antioxidant potential, liver enzymes, and expression of genes for autophagy and oxidative stress. Subjects will also complete 3-day food diaries and questionnaires on general health, physical activity, and quality of sleep and life.

On baseline and final (six months) measurements resting metabolic rate and DXA body composition measurements will be performed.

Enrollment: 60 estimated patients

Sex: All

Ages: 50 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body mass index (BMI) between 22 kg/m2 and 30 kg/m2
• Postmenopausal women (at least 12 months without menstruation)
• Healthy individuals, without risk of chronic non-communicable diseases
• Signed written informed consent

Exclusion criteria

1. Acute and chronic diseases (cardiovascular diseases, diabetes, neurodegenerative diseases, gastrointestinal diseases).
2. Patients with serious clinical conditions such as cancer, severe infections, severe psychiatric disorders, autoimmune diseases, inflammatory diseases.
3. BMI less than 22 kg/m2 and greater than 30 kg/m2.
4. Celiac disease or gluten intolerance.
5. Presence of implants, devices or other foreign materials in the measurement area.
6. Smoking.
7. Atypical sleep patterns.
8. Use of dietary supplements and medications.
9. Extreme physical activity.
10. Excessive alcohol consumption (more than one drink per day for women, more than two drinks per day for men).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

Morning- and evening-speciffic longevity food supplement

Experimental group

Description:

6-month daily consumption of 1 morning-specific capsule and 1 evening-specific capsule.

Treatment:

Dietary Supplement: Morning- and evening-specific compound food supplement

Control

Placebo Comparator group

Description:

6-month daily consumption of 2 capsules of maltodextrin.

Treatment:

Dietary Supplement: Control