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

Sponsor

Nutrition Institute, Slovenia (Other)

Overall Status

Completed

CT.gov ID

NCT05661006

Collaborator

Vizera d.o.o. (Industry), Frutarom Etol d.o.o. (Industry), European Regional Development Fund (Other)

Enrollment

Location

Arms

4.3

Actual Duration (Months)

9.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Vitamin d Deficiency Vitamin B 12 Deficiency Protein Deficiency	Dietary Supplement: Use of food supplement Dietary Supplement: Use of placebo food supplement	N/A

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?

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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:

Quadruple (Participant, Care Provider, Investigator, Outcomes 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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 20, 2020

Actual Primary Completion Date :

May 5, 2020

Actual Study Completion Date :

Jun 29, 2020

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control group Subjects taking control 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
Experimental: Active group 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

Arm

Intervention/Treatment

Placebo Comparator: Control group

Subjects taking control product

Dietary Supplement: Use of placebo food supplement

Experimental: Active group

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

Outcome Measures

Primary Outcome Measures

Difference between vitamin D serum levels in winter and in summer season will be determined [2 years]
Vitamin D serum level will be measured once in winter (December - January) and once in summer season (August-September) for each individual. The study will be performed over two consecutive years.

Secondary Outcome Measures

Correlation of vitamin D serum levels with Fitzpatrick skin phototype [2 years]
Fitzpatrick skin phototype will be determined using Fitzpatrick self-evaluation questionnaire in combination with expert assessment in August-September.
Correlation of vitamin D serum levels with skin colour measured in CIE Lab colour space [2 years]
Skin colour will be measured in CIE Lab colour space on inner and outer side of the upper arm. The measurement will be performed in August-September.
Correlation of vitamin D serum levels with melanin index [2 years]
Melanin index will be measured on inner and outer side of the upper arm. The measurement will be performed in August-September.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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
Plasma 25-OH-Vitamin D level below 20 µg/L
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VIZERA	Trzin		Slovenia

Sponsors and Collaborators

Nutrition Institute, Slovenia
Vizera d.o.o.
Frutarom Etol d.o.o.
European Regional Development Fund

Investigators

Principal Investigator: Mojca Miholič, MD, Researcher

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nutrition Institute, Slovenia

ClinicalTrials.gov Identifier:

NCT05661006

Other Study ID Numbers:

2020/1-ET-SK

First Posted:

Dec 21, 2022

Last Update Posted:

Dec 21, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Vitamin D Deficiency

Vitamin B 12 Deficiency

Protein Deficiency

Study Results

No Results Posted as of Dec 21, 2022