An interventional study of Use of food supplement and Use of placebo food supplement in Vitamin d Deficiency, Vitamin B 12 Deficiency and Protein Deficiency, sponsored by Nutrition Institute, Slovenia. Completed at 1 site in Slovenia. Open to participants aged 65 Years to 95 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-22.
Sponsored by Nutrition Institute, Slovenia · Not applicable, Interventional, and Treatment
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.
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?
Exclusion criteria:
Subjects taking control product
Dietary Supplement: Use of placebo food supplement
Subjects taking active product
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
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
Change in serum vitamin D levels will be determined
Serum level of 25-OH-vitamin D will be measured before and after the intervention for each individual.
Time frame: 56 days
Change in dietary protein intake will be determined
Dietary protein intake will be estimated before and after the intervention for each individual, using 3x24h food records.
Time frame: 56 days
Change in serum vitamin B12 levels will be determined
Serum level of vitamin B12 will be measured before and after the intervention for each individual.
Time frame: 56 days
Malnutrition at baseline
Risks for malnutritition at baseline will be assessed using dietary records (3x24h food record: energy, protein and plasma concentration of 25-OH-D and vitamin B12.
Time frame: baseline
Plan to share: No
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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Nutrition Institute, Slovenia