Nutrient DeficiencyNCT02980094
Milk Biofortification Promotes Health Benefits in Institutionalized Elderly
A study testing Milk Antioxidant group(A), Milk Oil group(O) and Milk Antioxidant and oil(AO) in people with Nutrient Deficiency and Age-Related Immunodeficiency, run by Eduardo Ferriolli at 1 site in Brazil.
Trial summary
The project aims to study the effects of inclusion of sunflower oil, vitamin E and selenium in the diet of dairy cows on milk composition and the influence of modified milk on nutrition and health of elderly. To achieve those goals, two experiments will be conducted, both lasting 12 weeks. Read more about this study
- Who is it for?
- Ages 60 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrient Deficiency, Age-Related Immunodeficiency, Vitamin E Deficiency
- What is being tested?
- Milk Antioxidant group(A), Milk Oil group(O) and Milk Antioxidant and oil(AO)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2011to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 110 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any institution residents that use milk in their usual diet.
Who cannot join
- Inability to drink
- Use of enteral diets
- Lactose intolerance
- Autoimmune disorders
- Infections, allergies or inflammation in the two weeks prior to blood collection.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Clinics Hospital of the Ribeirao Preto Medical School
Ribeirão Preto, São Paulo, 14048-900
About this study
Official title: Effects of Inclusion of Sunflower Oil, Vitamin E and Selenium in the Diet of Dairy Cows on Milk Composition and Its Influence on Nutrition and Health of Elderly
The project aims to study the effects of inclusion of sunflower oil, vitamin E and selenium in the diet of dairy cows on milk composition and the influence of modified milk on nutrition and health of elderly. To achieve those goals, two experiments will be conducted, both lasting 12 weeks. In the first one, 32 cows at the beginning of lactation will be allotted in a completely randomized block design with a 2 x 2 factorial arrangement of treatments, as follow: 1) control diet; 2) control diet plus selenium and vitamin E; 3) control diet plus sunflower oil diet; 4) control diet plus sunflower oil, selenium and vitamin E. This experiment seeks the development of modified milks through nutritional manipulation of cow's diet. Concomitantly, in the second experiment, 132 elderly people will receive the four different kinds of milk produced in the first experiment in a completely randomized block (gender) design. The selection of the elderly for each group shall be composed clinical evaluations. Will be conducted biochemical tests before and after supplementation of milk consumption (serum α-tocopherol, selenium, analysis of fatty acid profile). Assessment of nutritional status will be made body mass index (BMI) with each participant before and after the experiment of 12 weeks, including body composition by multifrequency bioelectrical impedance analysis (BIA), evaluating the strength of pressure of the hand portable dynamometer, demographics and food consumption. The study of human nutrition and health will be held in the form of a double-blind study. The second experiment aims to study nutrition and health of elderly people, as it is expected that milk produced with better fatty acid profile, vitamin and minerals can improve the inflammatory profile of markers of the elderly. This project is important for the human population in general, particularly elderly people, health workers, human and animal nutritionists, and especially for the milk chain, as it has a potential to develop new dairy products and boost milk consumption.
- Conditions
- Nutrient Deficiency, Age-Related Immunodeficiency, Vitamin E Deficiency, Selenium Deficiency, Fatty Acid Deficiency, Institutionalization; Disinhibited Attachment
- Being tested
- Milk Antioxidant group(A), Milk Oil group(O), Milk Antioxidant and oil(AO), Milk Control group(C)
- Keywords
- aging, nutrients, milk, dietary supplementation
- Medical subject headings
- Vitamin E Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milk Antioxidant group(A)Dietary supplement
Also called add control diet(C) in the cow's food, add selenium in the cow's food, add vitamin E in the cow's food
There is no intervention pre-specified before the institutionalized elderly to receive three times per day of milk (total 600ml of milk all day) produced by lactating cows fed with the following diets: control (C)+selenium and vitamin E (A).
Milk Oil group(O)Dietary supplement
Also called add control diet(C) in the cow's food, add sunflower oil group in the cow's food
There is no intervention pre-specified before the institutionalized elderly to receive three times per day of milk (total 600ml of milk all day) produced by lactating cows fed with the following diets: control (C)+sunflower oil (O).
Milk Antioxidant and oil(AO)Dietary supplement
Also called add control diet(C) in the cow's food, add selenium in the cow's food, add vitamin E in the cow's food, add sunflower oil in the cow's food
There is no intervention pre-specified before the institutionalized elderly to receive three times per day of milk (total 600ml of milk all day) produced by lactating cows fed with the following diets:control (C)+selenium, vitamin E and sunflower oil (AO).
Milk Control group(C)Dietary supplement
Also called add control diet (C) in the cow's food, without vitamin E in the cow's food, without selenium in the cow's food, without sunflower oil in the cow's food
There is no intervention pre-specified before the institutionalized elderly to receive three times per day of milk (total 600ml of milk all day) produced by lactating cows fed with the following diets: control (C)
| Study group | Role | What they receive |
|---|---|---|
| Milk Control group(C) | Placebo comparator | Using a randomized block design, 25 institutionalized elderly to receive the milk 3 times per day produced by lactating cows fed with the following diet, one of the group is control (C), without vitamin E, selenium, sunflower oil in the cow's food. Receives: Dietary Supplement: Milk Control group(C) |
| Milk Antioxidant group(A) | Experimental | Using a randomized block design, 25 institutionalized elderly to receive the milk produced by lactating cows fed with the following diet: control (C) +vitamin E+ selenium (A). Receives: Dietary Supplement: Milk Antioxidant group(A) |
| Milk Oil group(O) | Experimental | Using a randomized block design, 25 institutionalized elderly to receive the milk produced by lactating cows fed with the following diets: control (C)+sunflower oil (O). Receives: Dietary Supplement: Milk Oil group(O) |
| Milk Antioxidant and oil(AO) | Experimental | Using a randomized block design, 25 institutionalized elderly to receive the milk produced by lactating cows fed with the following diets: control C+sunflower oil+vitamin E+selenium (AO) . Receives: Dietary Supplement: Milk Antioxidant and oil(AO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum α-tocopherol
Assessment by blood sampling. Collect of α-tocopherol before and after to 12 weeks of milk supplementation
Measured: before and after 12 weeks
Change in serum selenium
Assessment by blood sampling. Collect of selenium before and after to 12 weeks milk supplementation
Measured: before and after 12 weeks
Change in analysis of fatty acid profile
Assessment by blood sampling. Collect of analysis of fatty acid profile before and after to 12 weeks of milk supplementation
Measured: before and after 12 weeks
Secondary outcomes (5)
Assessment of nutritional status: food intake questionnaire
Food consumption questionnaire during the milk supplementation
Measured: before and after 12 weeks
Change in handgrip strength
Measure of the hand grip strength using a portable dynamometer before and after 12 weeks of milk supplementation
Measured: before and after 12 weeks
Assessment of nutritional status: anthropometry (BMI)
BMI before and after 12 weeks of milk supplementation
Measured: before and after 12 weeks
Assessment of nutritional status: body composition
Body composition measured by multifrequency bioelectrical impedance analysis (BIA) before and after to 12 week of milk supplementation
Measured: before and after 12 weeks
Assessment demographics: questionnaire
Demographics questionnaire applied during the milk supplementation
Measured: before and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study startAug 2011
- Primary completionSep 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Nutrient DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eduardo Ferriolli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eduardo Ferriolli, University of Sao Paulo
- Investigators
- Eduardo Ferriolli, PhD, Principal investigator, Study Principal InvestigatorHelio Vannucchi, PhD, Study chair, Study Chair investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02980094
- Sponsor's protocol ID
- 4921/2011
- Status last verified
- Mar 2018
- First submitted
- 9 Nov 2016
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Barr SI, McCarron DA, Heaney RP, Dawson-Hughes B, Berga SL, Stern JS, Oparil S. Effects of increased consumption of fluid milk on energy and nutrient intake, body weight, and cardiovascular risk factors in healthy older adults. J Am Diet Assoc. 2000 Jul;100(7):810-7. doi: 10.1016/S0002-8223(00)00236-4.
PubMed 10916520Bouis HE, Hotz C, McClafferty B, Meenakshi JV, Pfeiffer WH. Biofortification: a new tool to reduce micronutrient malnutrition. Food Nutr Bull. 2011 Mar;32(1 Suppl):S31-40. doi: 10.1177/15648265110321S105.
PubMed 21717916Witkowska Z, Michalak I, Korczynski M, Szoltysik M, Swiniarska M, Dobrzanski Z, Tuhy L, Samoraj M, Chojnacka K. Biofortification of milk and cheese with microelements by dietary feed bio-preparations. J Food Sci Technol. 2015 Oct;52(10):6484-92. doi: 10.1007/s13197-014-1696-9. Epub 2015 Jan 21.
PubMed 26396393Kratz M, Baars T, Guyenet S. The relationship between high-fat dairy consumption and obesity, cardiovascular, and metabolic disease. Eur J Nutr. 2013 Feb;52(1):1-24. doi: 10.1007/s00394-012-0418-1. Epub 2012 Jul 19.
PubMed 22810464Pfrimer K, Ferriolli E, Takeuchi PL, Salles MS, Saran-Netto A, Zanetti MA, Roma-Junior LC, Braga CBM, Domenici FA, Valim YM, Paschoalato AB, Marchi LF, Azzolini AE, Donadi EA, Martinez E, Vannucchi H. Effects of the Consumption of Milk Biofortified with Selenium, Vitamin E, and Different Fatty Acid Profile on Immune Response in the Elderly. Mol Nutr Food Res. 2018 Feb;62(4). doi: 10.1002/mnfr.201700307. Epub 2018 Jan 15.
PubMed 29193757
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inclusion of Sunflower Oil, Vitamin E and Selenium in the Diet of Dairy Cows on Milk Composition and Its Influence on Nutrition and Health of Elderly
- ClinicalTrials.gov ID
- NCT02980094
- Acronym / sponsor ID
- 4921/2011
- Conditions
- Nutrient Deficiency, Age-Related Immunodeficiency, Vitamin E Deficiency, Selenium Deficiency, Fatty Acid Deficiency, Institutionalization; Disinhibited Attachment
- Keywords
- aging, nutrients, milk, dietary supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Eduardo FerriolliUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 2 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The project aims to study the effects of inclusion of sunflower oil, vitamin E and selenium in the diet of dairy cows on milk composition and the influence of modified milk on nutrition and health of elderly. To achieve those goals, two experiments will be conducted, both lasting 12 weeks. In the first one, 32 cows at the beginning of lactation will be allotted in a completely randomized block design with a 2 x 2 factorial arrangement of treatments, as follow: 1) control diet; 2) control diet plus selenium and vitamin E; 3) control diet plus sunflower oil diet; 4) control diet plus sunflower oil, selenium and vitamin E. This experiment seeks the development of modified milks through nutritional manipulation of cow's diet. Concomitantly, in the second experiment, 132 elderly people will receive the four different kinds of milk produced in the first experiment in a completely randomized block (gender) design. The selection of the elderly for each group shall be composed clinical evaluations. Will be conducted biochemical tests before and after supplementation of milk consumption (serum α-tocopherol, selenium, analysis of fatty acid profile). Assessment of nutritional status will be made body mass index (BMI) with each participant before and after the experiment of 12 weeks, including body composition by multifrequency bioelectrical impedance analysis (BIA), evaluating the strength of pressure of the hand portable dynamometer, demographics and food consumption. The study of human nutrition and health will be held in the form of a double-blind study. The second experiment aims to study nutrition and health of elderly people, as it is expected that milk produced with better fatty acid profile, vitamin and minerals can improve the inflammatory profile of markers of the elderly. This project is important for the human population in general, particularly elderly people, health workers, human and animal nutritionists, and especially for the milk chain, as it has a potential to develop new dairy products and boost milk consumption.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Milk Control group(C) | Placebo comparator | Dietary Supplement: Milk Control group(C)Using a randomized block design, 25 institutionalized elderly to receive the milk 3 times per day produced by lactating cows fed with the following diet, one of the group is control (C), without vitamin E, selenium, sunflower oil in the cow's food. |
| Milk Antioxidant group(A) | Experimental | Dietary Supplement: Milk Antioxidant group(A)Using a randomized block design, 25 institutionalized elderly to receive the milk produced by lactating cows fed with the following diet: control (C) +vitamin E+ selenium (A). |
| Milk Oil group(O) | Experimental | Dietary Supplement: Milk Oil group(O)Using a randomized block design, 25 institutionalized elderly to receive the milk produced by lactating cows fed with the following diets: control (C)+sunflower oil (O). |
| Milk Antioxidant and oil(AO) | Experimental | Dietary Supplement: Milk Antioxidant and oil(AO)Using a randomized block design, 25 institutionalized elderly to receive the milk produced by lactating cows fed with the following diets: control C+sunflower oil+vitamin E+selenium (AO) . |
Who may qualify
- Ages
- 60 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any institution residents that use milk in their usual diet.
Key exclusion criteria (5 listed)
- Inability to drink
- Use of enteral diets
- Lactose intolerance
- Autoimmune disorders
- Infections, allergies or inflammation in the two weeks prior to blood collection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Milk Antioxidant group(A)Also: add control diet(C) in the cow's food, add selenium in the cow's food, add vitamin E in the cow's foodThere is no intervention pre-specified before the institutionalized elderly to receive three times per day of milk (total 600ml of milk all day) produced by lactating cows fed with the following diets: control (C)+selenium and vitamin E (A). | Dietary supplement | Milk Antioxidant group(A) |
| Milk Oil group(O)Also: add control diet(C) in the cow's food, add sunflower oil group in the cow's foodThere is no intervention pre-specified before the institutionalized elderly to receive three times per day of milk (total 600ml of milk all day) produced by lactating cows fed with the following diets: control (C)+sunflower oil (O). | Dietary supplement | Milk Oil group(O) |
| Milk Antioxidant and oil(AO)Also: add control diet(C) in the cow's food, add selenium in the cow's food, add vitamin E in the cow's food, add sunflower oil in the cow's foodThere is no intervention pre-specified before the institutionalized elderly to receive three times per day of milk (total 600ml of milk all day) produced by lactating cows fed with the following diets:control (C)+selenium, vitamin E and sunflower oil (AO). | Dietary supplement | Milk Antioxidant and oil(AO) |
| Milk Control group(C)Also: add control diet (C) in the cow's food, without vitamin E in the cow's food, without selenium in the cow's food, without sunflower oil in the cow's foodThere is no intervention pre-specified before the institutionalized elderly to receive three times per day of milk (total 600ml of milk all day) produced by lactating cows fed with the following diets: control (C) | Dietary supplement | Milk Control group(C) |
Primary outcome
Change in serum α-tocopherol
Time frame: before and after 12 weeks
Assessment by blood sampling. Collect of α-tocopherol before and after to 12 weeks of milk supplementation
Change in serum selenium
Time frame: before and after 12 weeks
Assessment by blood sampling. Collect of selenium before and after to 12 weeks milk supplementation
Change in analysis of fatty acid profile
Time frame: before and after 12 weeks
Assessment by blood sampling. Collect of analysis of fatty acid profile before and after to 12 weeks of milk supplementation
5 secondary outcomes
Assessment of nutritional status: food intake questionnaire
Time frame: before and after 12 weeks
Change in handgrip strength
Time frame: before and after 12 weeks
Assessment of nutritional status: anthropometry (BMI)
Time frame: before and after 12 weeks
Assessment of nutritional status: body composition
Time frame: before and after 12 weeks
Assessment demographics: questionnaire
Time frame: before and after 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2018.
- Results publication: PubMed 10916520Barr SI, McCarron DA, Heaney RP, Dawson-Hughes B, Berga SL, Stern JS, Oparil S. Effects of increased consumption of fluid milk on energy and nutrient intake, body weight, and cardiovascular risk factors in healthy older adults. J Am Diet Assoc. 2000 Jul;100(7):810-7. doi: 10.1016/S0002-8223(00)00236-4.
- Results publication: PubMed 21717916Bouis HE, Hotz C, McClafferty B, Meenakshi JV, Pfeiffer WH. Biofortification: a new tool to reduce micronutrient malnutrition. Food Nutr Bull. 2011 Mar;32(1 Suppl):S31-40. doi: 10.1177/15648265110321S105.
- Results publication: PubMed 26396393Witkowska Z, Michalak I, Korczynski M, Szoltysik M, Swiniarska M, Dobrzanski Z, Tuhy L, Samoraj M, Chojnacka K. Biofortification of milk and cheese with microelements by dietary feed bio-preparations. J Food Sci Technol. 2015 Oct;52(10):6484-92. doi: 10.1007/s13197-014-1696-9. Epub 2015 Jan 21.
- Results publication: PubMed 22810464Kratz M, Baars T, Guyenet S. The relationship between high-fat dairy consumption and obesity, cardiovascular, and metabolic disease. Eur J Nutr. 2013 Feb;52(1):1-24. doi: 10.1007/s00394-012-0418-1. Epub 2012 Jul 19.
- Derived from this study: PubMed 29193757Pfrimer K, Ferriolli E, Takeuchi PL, Salles MS, Saran-Netto A, Zanetti MA, Roma-Junior LC, Braga CBM, Domenici FA, Valim YM, Paschoalato AB, Marchi LF, Azzolini AE, Donadi EA, Martinez E, Vannucchi H. Effects of the Consumption of Milk Biofortified with Selenium, Vitamin E, and Different Fatty Acid Profile on Immune Response in the Elderly. Mol Nutr Food Res. 2018 Feb;62(4). doi: 10.1002/mnfr.201700307. Epub 2018 Jan 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo Ferriolli, PhD principal investigator
Study Principal Investigator
Helio Vannucchi, PhD study chair
Study Chair investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milk Antioxidant group(A), Milk Oil group(O) and Milk Antioxidant and oil(AO) in people with Nutrient Deficiency and Age-Related Immunodeficiency, run by Eduardo Ferriolli at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum α-tocopherol (time frame: before and after 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02980094, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2018; AzTrials last refreshed its copy on 6 Nov 2026.