Back to resultsETOL-Elderly Study of the Efficiency of the Innovative Food Supplement in Elderly Adults (ETOL-Elderly)
Primary Purpose
Vitamin d Deficiency, Vitamin B 12 Deficiency, Protein Deficiency
Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Use of food supplement
Use of placebo food supplement
Sponsored by
About this trial
This is an interventional treatment trial for Vitamin d Deficiency
Eligibility Criteria
Inclusion criteria: 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) Exclusion criteria: 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 Participation in another investigational study
Sites / Locations
- VIZERA
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control group
Active group
Arm Description
Subjects taking control product
Subjects taking active product
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT05661006
First Posted
December 13, 2022
Last Updated
June 19, 2023
Sponsor
Nutrition Institute, Slovenia
Collaborators
Vizera d.o.o., Frutarom Etol d.o.o., European Regional Development Fund
1. Study Identification
Unique Protocol Identification Number
NCT05661006
Brief Title
ETOL-Elderly Study of the Efficiency of the Innovative Food Supplement in Elderly Adults
Acronym
ETOL-Elderly
Official Title
Study of the Efficiency of the Innovative Food Supplement in Improving Nutritional Status of Elderly Adults
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
February 20, 2020 (Actual)
Primary Completion Date
May 5, 2020 (Actual)
Study Completion Date
June 29, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nutrition Institute, Slovenia
Collaborators
Vizera d.o.o., Frutarom Etol d.o.o., European Regional Development Fund
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin d Deficiency, Vitamin B 12 Deficiency, Protein Deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Subjects taking control product
Arm Title
Active group
Arm Type
Experimental
Arm Description
Subjects taking active product
Intervention Type
Dietary Supplement
Intervention Name(s)
Use of food supplement
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Use of placebo food supplement
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in serum vitamin D levels will be determined
Description
Serum level of 25-OH-vitamin D will be measured before and after the intervention for each individual.
Time Frame
56 days
Secondary Outcome Measure Information:
Title
Change in dietary protein intake will be determined
Description
Dietary protein intake will be estimated before and after the intervention for each individual, using 3x24h food records.
Time Frame
56 days
Title
Change in serum vitamin B12 levels will be determined
Description
Serum level of vitamin B12 will be measured before and after the intervention for each individual.
Time Frame
56 days
Title
Malnutrition at baseline
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
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)
Exclusion criteria:
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
Participation in another investigational study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mojca Miholič, MD
Organizational Affiliation
Researcher
Official's Role
Principal Investigator
Facility Information:
Facility Name
VIZERA
City
Trzin
Country
Slovenia
12. IPD Sharing Statement
Plan to Share IPD
No
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ETOL-Elderly Study of the Efficiency of the Innovative Food Supplement in Elderly Adults
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