Dietary Intervention With Únicla Dairy Products (DANTIAN)

NCT05019118 | Unknown DMC

• 1 other identifier: CLUN-20191005
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Subclinical Hypothyroidism

Keywords

Hypothyroidism; selenium; women

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with changes in thyroid function

  thyroid stimulating hormone blood level

  3 months

Secondary Outcomes (4)

• HDL level

  3 months

• selenium

  3 months

• IL-6

  3 months

• Fecal calprotectin

  3 months

Study Arms (2)

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

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

Other: Placebo milk; Other: Placebo yogur; Other: Placebo fresh cheese

Interventions

Experimental milk OTHER

UNICLA milk naturally enriched in selenium and omega-3.

Also known as: ÚNICLA milk

Intervention/treatment

Experimental yogur OTHER

UNICLA yogur naturally enriched in selenium and omega-3.

Also known as: ÚNICLA yogur

Intervention/treatment

Experimental fresh cheese OTHER

UNICLA fresh cheese naturally enriched in selenium and omega-3.

Also known as: ÚNICLA fresh cheese

Intervention/treatment

Placebo milk OTHER

Conventional milk

Also known as: Conventional milk

Conventional milk

Placebo yogur OTHER

Conventional yogur

Also known as: Conventional yogur

Conventional milk

Placebo fresh cheese OTHER

Conventional fresh cheese

Also known as: Conventional fresh cheese

Conventional milk

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cooperativas Lacteas Unidas: lead
• Galician South Health Research Institute: collaborator

Study Sites (1)

Nursing University School of Ourense

Ourense, 32005, Spain

Location

Related Publications (2)

• 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.

  PMID: 27239712 BACKGROUND

• 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.

  PMID: 16332137 BACKGROUND

Related Links

• Article preprint magazine Nutrition Hospitalaria

MeSH Terms

Conditions

Hypothyroidism

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Study Officials

• Maria Reyes Pérez- Fernández, PhD

  Galicia sur sanitary research institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

María Reyes Pérez-Fernández, PhD

CONTACT

676520946; Maria.Reyes.Perez.Fernandez@sergas.es

Ismael Martínez-Lede, graduate

CONTACT

0034609563353; ismael.martinez@clun.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Clinical Professor

Model Details: Randomized, masked and controlled nutritional intervention study

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: August 24, 2021
• Study Start: September 6, 2021
• Primary Completion: December 30, 2021
• Study Completion: May 30, 2022
• Last Updated: August 24, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)