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Dietary Intervention With Únicla Dairy Products (DANTIAN) (DANTIAN)

Primary Purpose

Subclinical Hypothyroidism

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Experimental milk
Experimental yogur
Experimental fresh cheese
Placebo milk
Placebo yogur
Placebo fresh cheese
Sponsored by
Cooperativas Lacteas Unidas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Subclinical Hypothyroidism focused on measuring Hypothyroidism, selenium, women

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • Nursing University School of Ourense

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention/treatment

Conventional milk

Arm Description

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

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

Outcomes

Primary Outcome Measures

Percentage of patients with changes in thyroid function
thyroid stimulating hormone blood level

Secondary Outcome Measures

HDL level
high density lipoproteins blood level
selenium
selenium blood level
IL-6
Interleukina-6 blood level
Fecal calprotectin
Fecal calprotectin feces level

Full Information

First Posted
August 13, 2021
Last Updated
August 20, 2021
Sponsor
Cooperativas Lacteas Unidas
Collaborators
Galician South Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05019118
Brief Title
Dietary Intervention With Únicla Dairy Products (DANTIAN)
Acronym
DANTIAN
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 6, 2021 (Anticipated)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
May 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cooperativas Lacteas Unidas
Collaborators
Galician South Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subclinical Hypothyroidism
Keywords
Hypothyroidism, selenium, women

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, masked and controlled nutritional intervention study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The masking process will be triple blind, that is, both the participating women, the research staff (including those in charge of delivering the products and the one who performs and interprets the measurements), as well as the analyst, won't know at any time what group belong to patients. All the products in the study (Únicla dairy) as well as their respective placebos (conventional FEIRACO equivalent products) will maintain a similar format and labeling, with the organoleptic characteristics of dairy products being very similar. Masking will be opened at the time that the last data interpretation of the last subject included was made and before starting the statistical analysis
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention/treatment
Arm Type
Experimental
Arm Description
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
Arm Title
Conventional milk
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Experimental milk
Other Intervention Name(s)
ÚNICLA milk
Intervention Description
UNICLA milk naturally enriched in selenium and omega-3.
Intervention Type
Other
Intervention Name(s)
Experimental yogur
Other Intervention Name(s)
ÚNICLA yogur
Intervention Description
UNICLA yogur naturally enriched in selenium and omega-3.
Intervention Type
Other
Intervention Name(s)
Experimental fresh cheese
Other Intervention Name(s)
ÚNICLA fresh cheese
Intervention Description
UNICLA fresh cheese naturally enriched in selenium and omega-3.
Intervention Type
Other
Intervention Name(s)
Placebo milk
Other Intervention Name(s)
Conventional milk
Intervention Description
Conventional milk
Intervention Type
Other
Intervention Name(s)
Placebo yogur
Other Intervention Name(s)
Conventional yogur
Intervention Description
Conventional yogur
Intervention Type
Other
Intervention Name(s)
Placebo fresh cheese
Other Intervention Name(s)
Conventional fresh cheese
Intervention Description
Conventional fresh cheese
Primary Outcome Measure Information:
Title
Percentage of patients with changes in thyroid function
Description
thyroid stimulating hormone blood level
Time Frame
3 months
Secondary Outcome Measure Information:
Title
HDL level
Description
high density lipoproteins blood level
Time Frame
3 months
Title
selenium
Description
selenium blood level
Time Frame
3 months
Title
IL-6
Description
Interleukina-6 blood level
Time Frame
3 months
Title
Fecal calprotectin
Description
Fecal calprotectin feces level
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
María Reyes Pérez-Fernández, PhD
Phone
676520946
Email
Maria.Reyes.Perez.Fernandez@sergas.es
First Name & Middle Initial & Last Name or Official Title & Degree
Ismael Martínez-Lede, graduate
Phone
0034609563353
Email
ismael.martinez@clun.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Reyes Pérez- Fernández, PhD
Organizational Affiliation
Galicia sur sanitary research institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nursing University School of Ourense
City
Ourense
ZIP/Postal Code
32005
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
María Reyes Pérez-Fernández, PhD
Phone
0034676520946
Email
Maria.Reyes.Perez.Fernandez@sergas.es
First Name & Middle Initial & Last Name & Degree
Ismael Martínez Lede, graduate
Phone
0034609563353
Email
ismael.martinez@clun.es

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27239712
Citation
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.
Results Reference
background
PubMed Identifier
16332137
Citation
Muniz-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.
Results Reference
background
Links:
URL
https://www.google.com/search?q=Efectos+de+la+ingesta+de+l%C3%A1cteos+enriquecidos+de+forma+natural+con+selenio+y+omega-3+en+una+muestra+de+mujeres+postmenop%C3%A1usicas+con+s%C3%ADndrome+metab%C3%B3lico%3A+un+ensayo+cl%C3%ADnico+aleatorizado+triple+ciego+y+controlado+con+placebo&oq=Efectos+de+la+ingesta+de+l%C3%A1cteos+enriquecidos+de+forma+natural+con+selenio+y+omega-3+en+una+muestra+de+mujeres+postmenop%C3%A1usicas+con+s%C3%ADndrome+metab%C3%B3lico%3A+un+ensayo+cl%C3%ADnico+aleatorizado+triple+ciego+y+controlado+con+placebo&aqs=chrome..69i57.5124j0j4&sourceid=chrome&ie=UTF-8
Description
Article preprint magazine Nutrition Hospitalaria

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Dietary Intervention With Únicla Dairy Products (DANTIAN)

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