Subclinical HypothyroidismDANTIANNCT05019118
Dietary Intervention With Únicla Dairy Products (DANTIAN)
A study testing Experimental milk, Experimental yogur and Experimental fresh cheese in people with Subclinical Hypothyroidism, run by Cooperativas Lacteas Unidas at 1 site in Spain.
Trial summary
Dietary intervention with Únicla dairy products, naturally enriched with selenium and omega-3 fatty acids, may improve thyroid-stimulating hormone (TSH) levels in women with subclinical hypothyroidism Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Subclinical Hypothyroidism
- What is being tested?
- Experimental milk, Experimental yogur and Experimental fresh cheese
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 6 Sep 2021to 30 May 2022
- 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 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of subclinical hypothyroidism
- TSH levels between 3 and 10 mIU / L
- Normal levels of free triiodothyronine ( T3) and free thyroxine (T4)
- Without previous or current treatment with levothyroxine
Who cannot join
- Thyroid surgery or reception of radioactive iodine in a previous period of 12 months
- History of cardiovascular disease and / or thrombosis
- Established diagnosis or clinical suspicion of kidney or liver failure, chronic infections, blood diseases, type I diabetes and type II diabetes
- Drug treatments that affect thyroid function (corticosteroids, amiodarone, propranolol, lithium)
- Statin treatment and / or hormone replacement therapy
- Adjuvant treatment with trace elements, vitamins or antidepressant and antipsychotic drugs
Show all 15Show fewer
- Hospitalization for serious illness or elective surgery in the past 4 weeks
- Diseases and / or treatments that affect intestinal absorption (proton pump inhibitors)
- Pregnant, planning to become pregnant or breastfeeding women
- Consumption of ω-3 PUFA type food supplements
- Intolerance and / or allergy to lactose and / or cow's milk proteins
- Any pathology that requires close control, advises against their participation or there is an inability to move independently
- Habitual residence outside the study's influence area
- Participation in another clinical trial with drugs, or in other experimental studies
- Refuse to sign the informed consent
Trial locations and contacts
1 site in 1 country.
Spain1 site
Nursing University School of Ourense
Ourense, 32005
María Reyes Pérez-Fernández, PhD, 0034676520946, Maria.Reyes.Perez.Fernandez@sergas.es
Ismael Martínez Lede, graduate, 0034609563353, ismael.martinez@clun.es
About this study
Official title: Dietary Intervention With Únicla Dairy Products, Naturally Enriched With Selenium and Omega-3 Fatty Acids, May Improve Thyroid-stimulating Hormone (TSH) Levels in Women With Subclinical Hypothyroidism
Dietary intervention with Únicla dairy products, naturally enriched with selenium and omega-3 fatty acids, may improve thyroid-stimulating hormone (TSH) levels in women with subclinical hypothyroidism
Read the detailed description
To analyze in women diagnosed with subclinical hypothyroidism, the effects of consumption of dairy products rich in selenium and omega-3 on symptoms related to thyroid disease and blood lipid profile, inflammatory response, and fatty acid levels in the red blood cell membrane among others.
- Conditions
- Subclinical Hypothyroidism
- Being tested
- Experimental milk, Experimental yogur, Experimental fresh cheese, Placebo milk, Placebo yogur
- Keywords
- Hypothyroidism, selenium, women
- Medical subject headings
- Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental milkOther
Also called ÚNICLA milk
UNICLA milk naturally enriched in selenium and omega-3.
Experimental yogurOther
Also called ÚNICLA yogur
UNICLA yogur naturally enriched in selenium and omega-3.
Experimental fresh cheeseOther
Also called ÚNICLA fresh cheese
UNICLA fresh cheese naturally enriched in selenium and omega-3.
Placebo milkOther
Also called Conventional milk
Conventional milk
Placebo yogurOther
Also called Conventional yogur
Conventional yogur
Placebo fresh cheeseOther
Also called Conventional fresh cheese
Conventional fresh cheese
| Study group | Role | What they receive |
|---|---|---|
| Intervention/treatment | Experimental | Dairy foods made with UNICLA milk Participants (n = 45) ingested UNICLA milk and dairy products (yogurt and cheese) for three months.
UNICLA milk is characterised by an improved nutritional composition, obtained by modifying cow's diet, feeeding the dairy cows with a sufficient and balanced ration, which recreates the fatty acid profile of the spring.
This ration includes pastures, high-quality forages and, among other components, a significant amount of flax seeds, which constitute a source of unsaturated fatty acids such as omega-3 and selenised yeast, as a source of organic selenium.
Consequently, UNICLA milk and dairy products are naturally enriched in selenium and ω-3 PUFA.
The daily intake reflects the usual consumption habits, being the recommended amounts of 200 ml of milk and 125 g of yogurt per day and 400g of fresh cheese per week Receives: Other: Experimental milk; Other: Experimental yogur; Other: Experimental fresh cheese |
| Conventional milk | Placebo comparator | Participants (n = 45) ingest milk and conventional dairy products daily for 3 months.
Daily intake reflects usual dairy consumption habits in "real life" conditions, without forcing or inducing increased consumption. Therefore, the recommended amounts are 200 ml of milk and 125 g of yogurt per day and 400 g of fresh cheese per week Receives: Other: Placebo milk; Other: Placebo yogur; Other: Placebo fresh cheese |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with changes in thyroid function
thyroid stimulating hormone blood level
Measured: 3 months
Secondary outcomes (4)
HDL level
high density lipoproteins blood level
Measured: 3 months
selenium
selenium blood level
Measured: 3 months
IL-6
Interleukina-6 blood level
Measured: 3 months
Fecal calprotectin
Fecal calprotectin feces level
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start6 Sep 2021 (estimated)
- Primary completion30 Dec 2021 (estimated)
- Study completion30 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Subclinical HypothyroidismStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, masked and controlled nutritional intervention study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cooperativas Lacteas Unidas
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Galician South Health Research Institute
- Responsible party
- Principal investigator, María Reyes Pérez Fernández, Galician South Health Research Institute
- Investigators
- Maria Reyes Pérez- Fernández, PhD, Principal investigator, Galicia sur sanitary research institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019118
- Sponsor's protocol ID
- CLUN-20191005
- Acronym
- DANTIAN
- Status last verified
- Aug 2021
- First submitted
- 13 Aug 2021
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roibas L, Martinez I, Goris A, Barreiro R, Hospido A. An analysis on how switching to a more balanced and naturally improved milk would affect consumer health and the environment. Sci Total Environ. 2016 Oct 1;566-567:685-697. doi: 10.1016/j.scitotenv.2016.05.141. Epub 2016 May 27.
PubMed 27239712Muniz-Naveiro O, Dominguez-Gonzalez R, Bermejo-Barrera A, Cocho de Juan JA, Fraga Bermudez JM, Goris Pereiras A, Lopez Santamarina A, Martinez Lede I, Valledor Puente J, Fernandez-Couto Gomez L, Bermejo-Barrera P. Selenium content and distribution in cow's milk supplemented with two dietary selenium sources. J Agric Food Chem. 2005 Dec 14;53(25):9817-22. doi: 10.1021/jf050155w.
PubMed 16332137
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Intervention With Únicla Dairy Products, Naturally Enriched With Selenium and Omega-3 Fatty Acids, May Improve Thyroid-stimulating Hormone (TSH) Levels in Women With Subclinical Hypothyroidism
- ClinicalTrials.gov ID
- NCT05019118
- Acronym / sponsor ID
- DANTIAN / CLUN-20191005
- Conditions
- Subclinical Hypothyroidism
- Keywords
- Hypothyroidism, selenium, women
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Cooperativas Lacteas UnidasIndustry (pharma, biotech, devices)
- Collaborators
- Galician South Health Research Institute
- Study start
- 6 Sep 2021 (estimated)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 24 Aug 2021 (actual)
- 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.
Dietary intervention with Únicla dairy products, naturally enriched with selenium and omega-3 fatty acids, may improve thyroid-stimulating hormone (TSH) levels in women with subclinical hypothyroidism
Detailed description
To analyze in women diagnosed with subclinical hypothyroidism, the effects of consumption of dairy products rich in selenium and omega-3 on symptoms related to thyroid disease and blood lipid profile, inflammatory response, and fatty acid levels in the red blood cell membrane among others.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, masked and controlled nutritional intervention study
| Arm | Type | Receives |
|---|---|---|
| Intervention/treatment | Experimental | Other: Experimental milk, Other: Experimental yogur, Other: Experimental fresh cheeseDairy foods made with UNICLA milk Participants (n = 45) ingested UNICLA milk and dairy products (yogurt and cheese) for three months. UNICLA milk is characterised by an improved nutritional composition, obtained by modifying cow's diet, feeeding the dairy cows with a sufficient and balanced ration, which recreates the fatty acid profile of the spring. This ration includes pastures, high-quality forages and, among other components, a significant amount of flax seeds, which constitute a source of unsaturated fatty acids such as omega-3 and selenised yeast, as a source of organic selenium. Consequently, UNICLA milk and dairy products are naturally enriched in selenium and ω-3 PUFA. The daily intake reflects the usual consumption habits, being the recommended amounts of 200 ml of milk and 125 g of yogurt per day and 400g of fresh cheese per week |
| Conventional milk | Placebo comparator | Other: Placebo milk, Other: Placebo yogur, Other: Placebo fresh cheeseParticipants (n = 45) ingest milk and conventional dairy products daily for 3 months. Daily intake reflects usual dairy consumption habits in "real life" conditions, without forcing or inducing increased consumption. Therefore, the recommended amounts are 200 ml of milk and 125 g of yogurt per day and 400 g of fresh cheese per week |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of subclinical hypothyroidism
- TSH levels between 3 and 10 mIU / L
- Normal levels of free triiodothyronine ( T3) and free thyroxine (T4)
- Without previous or current treatment with levothyroxine
Key exclusion criteria (15 listed)
- Thyroid surgery or reception of radioactive iodine in a previous period of 12 months
- History of cardiovascular disease and / or thrombosis
- Established diagnosis or clinical suspicion of kidney or liver failure, chronic infections, blood diseases, type I diabetes and type II diabetes
- Drug treatments that affect thyroid function (corticosteroids, amiodarone, propranolol, lithium)
- Statin treatment and / or hormone replacement therapy
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 |
|---|---|---|
| Experimental milkAlso: ÚNICLA milkUNICLA milk naturally enriched in selenium and omega-3. | Other | Intervention/treatment |
| Experimental yogurAlso: ÚNICLA yogurUNICLA yogur naturally enriched in selenium and omega-3. | Other | Intervention/treatment |
| Experimental fresh cheeseAlso: ÚNICLA fresh cheeseUNICLA fresh cheese naturally enriched in selenium and omega-3. | Other | Intervention/treatment |
| Placebo milkAlso: Conventional milkConventional milk | Other | Conventional milk |
| Placebo yogurAlso: Conventional yogurConventional yogur | Other | Conventional milk |
| Placebo fresh cheeseAlso: Conventional fresh cheeseConventional fresh cheese | Other | Conventional milk |
Primary outcome
Percentage of patients with changes in thyroid function
Time frame: 3 months
thyroid stimulating hormone blood level
4 secondary outcomes
HDL level
Time frame: 3 months
selenium
Time frame: 3 months
IL-6
Time frame: 3 months
Fecal calprotectin
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Background: PubMed 27239712Roibas L, Martinez I, Goris A, Barreiro R, Hospido A. An analysis on how switching to a more balanced and naturally improved milk would affect consumer health and the environment. Sci Total Environ. 2016 Oct 1;566-567:685-697. doi: 10.1016/j.scitotenv.2016.05.141. Epub 2016 May 27.
- Background: PubMed 16332137Muniz-Naveiro O, Dominguez-Gonzalez R, Bermejo-Barrera A, Cocho de Juan JA, Fraga Bermudez JM, Goris Pereiras A, Lopez Santamarina A, Martinez Lede I, Valledor Puente J, Fernandez-Couto Gomez L, Bermejo-Barrera P. Selenium content and distribution in cow's milk supplemented with two dietary selenium sources. J Agric Food Chem. 2005 Dec 14;53(25):9817-22. doi: 10.1021/jf050155w.
- Article preprint magazine Nutrition HospitalariaLink provided by the sponsor.
- 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.
Maria Reyes Pérez- Fernández, PhD principal investigator
Galicia sur sanitary research institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental milk, Experimental yogur and Experimental fresh cheese in people with Subclinical Hypothyroidism, run by Cooperativas Lacteas Unidas at 1 site in Spain.
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 4 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 24 Aug 2021. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact María Reyes Pérez-Fernández, PhD (676520946, Maria.Reyes.Perez.Fernandez@sergas.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with changes in thyroid function (time frame: 3 months). 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 NCT05019118, which also lists 2 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 24 Aug 2021.