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

NCT05661006 | Completed

• 1 other identifier: 2020/1-ET-SK
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vitamin d Deficiency; Vitamin B 12 Deficiency; Protein Deficiency

Outcome Measures

Primary Outcomes (1)

• 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.

  56 days

Secondary Outcomes (3)

• Change in dietary protein intake will be determined

  56 days

• Change in serum vitamin B12 levels will be determined

  56 days

• Malnutrition at baseline

  baseline

Study Arms (2)

Control group

PLACEBO COMPARATOR

Subjects taking control product

Dietary Supplement: Use of placebo food supplement

Active group

EXPERIMENTAL

Subjects taking active product

Dietary Supplement: Use of food supplement

Interventions

Use of food supplement DIETARY_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

Active group

Use of placebo food supplement DIETARY_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

Control group

Eligibility Criteria

• Age: 65 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Subject Informed consent form (ICF) is singed
• Aged at least 65 at the time of the signature of ICF
• A body mass index lower than 32 kg/m2
• Willing to avoid a consumption supplementation with protein, vitamin D and vitamin B12 during the study
• Willing to follow all study procedures, including attending all site visits (including blood sampling) and keeping a diary for using the product and six 24-hour dietary records (3x pre-intervention, 3x during last week of the intervention)

You may not qualify if:

• Medical treatment with Vitamin D and/or Vitamin B12
• Supplementation with protein, vitamin D and/or vitamin B12 during least 2 months
• Known drug and/or alcohol abuse
• Known lactose/gluten intolerances/food allergies
• Inadequate veins (in the opinion of the investigator) or known contraindication for venous blood withdrawal
• Have chronic bowel disease (ulcerative colitis, Chron's disease, stomach or duodenal ulcer, chronic inflammation of the stomach or duodenum)
• Have acute gastrointestinal infection with vomiting and / or diarrhea
• Have planned general anaesthesia or colonoscopy at the time of the study
• Have malabsorption syndrome
• Less than 5 years after treatment for gastrointestinal cancer (stomach, duodenum or colon)
• Have stomach or bowel resection
• Do not have neat and functional teeth
• Take regular or occasional laxative products
• Use antacids (Rupurut / Rutacid / Talcit)
• Mental incapacity that precludes adequate understanding or cooperation

Sponsors & Collaborators

• Institute of Nutrition, Slovenia (Nutris): lead
• Vizera d.o.o.: collaborator
• Frutarom Etol d.o.o.: collaborator
• European Regional Development Fund: collaborator

Study Sites (1)

VIZERA

Trzin, Slovenia

Location

MeSH Terms

Conditions

Vitamin D Deficiency; Vitamin B 12 Deficiency; Protein Deficiency

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Vitamin B Deficiency

Study Officials

• Mojca Miholič, MD

  Researcher

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects will be randomized on the first day of Visit 1 using simple randomisation using ratio 1:1 between test and placebo group. After the general subject's health is checked (vital signs), subjects will be assigned Subject Number, which will be pre-randomised to correspond with one of interventions (test group, placebo group). To assure double blind approach, study products will be packed in neutral packaging, and pre-labelled with Subject Number (S-XXX) and instructions for use. Selected site will be provided enough product i.e. subject boxes with corresponding Subject Number to cover initially planned number of included subject.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This was a randomized, parallel, double-blind, placebo-controlled study included healthy elderly adults (age \> 65 years) who tested study products. On screening visit, participants underwent measuring of body weight \& height, and blood collection for measuring S-25-OH-VitD, S-VitB12, S-protein, S-albumin, S-CRP. Duration of study intervention for individual participant 56 ± 3 days, with one week pre-intervention monitoring of food intake (3x 24-h dietary records). On day 1 of the intervention period, participants were randomised in a 1:1 ratio.

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: December 21, 2022
• Study Start: February 20, 2020
• Primary Completion: May 5, 2020
• Study Completion: June 29, 2020
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)