NCT05661006

ETOL-Elderly Study of the Efficiency of the Innovative Food Supplement in Elderly Adults

Study of the Efficiency of the Innovative Food Supplement in Improving Nutritional Status of Elderly Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Institute of Nutrition, Slovenia (Nutris) · Academic / Other
• Sex: All
• Age: 65 Years – 95 Years
• Healthy volunteers: Accepted

Summary

The aim of this pilot study is to conduct a study on geriatric population in Slovenia (non-users of dietary supplements/medicines with vitamine D, vitamin B12 and protein) and assess deficiency of selected nutrients, and to investigate the efficiency of the innovative food supplement prototype in improving nutritional status of elderly adults.

Detailed description

The main objective is to show that in the geriatric population regular use of investigation food supplement would improve nutritional status. The study should provide answers to the following main questions: (1) Is regular use of investigated product beneficial for improving serum vitamin D levels in elderly population? (2) Is regular use of investigated product beneficial for increasing daily protein intake in elderly population? (3) Is regular use of investigated product beneficial for improving vitamin B12 status in elderly population?

Conditions

• Vitamin d Deficiency
• Vitamin B 12 Deficiency
• Protein Deficiency

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Use of food supplement	On day 1 subjects start with intervention on prearranged day. First dosage of test product is consumed during day 1 between regular meals (not as meal substitute). In the following days: continuation of consumption of test product once per day until end of the intervention. Subjects are recording daily consumption of the product. Intervention diet recording during last week of intervention (days 49-56): 3x24h dietary records (two days during weekday, one weekend day). Intervention end on day 56 ±3 (fasted condition): Measuring S-25-OH-VitD, S-VitB12, S-protein, S-albumin, S-CRP Measuring body weight \& height Collecting data regarding the palatability of the product
DIETARY_SUPPLEMENT	Use of placebo food supplement	On day 1 subjects start with intervention on prearranged day. First dosage of test product is consumed during day 1 between regular meals (not as meal substitute). In the following days: continuation of consumption of test product once per day until end

Timeline

• Start date: 2020-02-20
• Primary completion: 2020-05-05
• Completion: 2020-06-29
• First posted: 2022-12-21
• Last updated: 2023-06-22

Locations

1 site across 1 country: Slovenia