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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Subclinical Hypothyroidism
• Intervention / Treatment: Other: Experimental milk; Other: Experimental yogur; Other: Experimental fresh cheese; Other: Placebo milk; Other: Placebo yogur; Other: Placebo fresh cheese

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 Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: María Reyes Pérez-Fernández, PhD; Phone Number: 676520946; Email: Maria.Reyes.Perez.Fernandez@sergas.es
• Study Contact Backup: Name: Ismael Martínez-Lede, graduate; Phone Number: 0034609563353; Email: ismael.martinez@clun.es

Study Locations

• Spain
  • Ourense, Spain, 32005
    • Nursing University School of Ourense
    • Contact: María Reyes Pérez-Fernández, PhD; Phone Number: 0034676520946; Email: Maria.Reyes.Perez.Fernandez@sergas.es
    • Contact: Ismael Martínez Lede, graduate; Phone Number: 0034609563353; Email: ismael.martinez@clun.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention/treatment; 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; UNICLA milk naturally enriched in selenium and omega-3.; Other Names: ÚNICLA milk; Other: Experimental yogur; UNICLA yogur naturally enriched in selenium and omega-3.; Other Names: ÚNICLA yogur; Other: Experimental fresh cheese; UNICLA fresh cheese naturally enriched in selenium and omega-3.; Other Names: ÚNICLA fresh cheese
Placebo Comparator: Conventional milk; 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; Conventional milk; Other Names: Conventional milk; Other: Placebo yogur; Conventional yogur; Other Names: Conventional yogur; Other: Placebo fresh cheese; Conventional fresh cheese; Other Names: Conventional fresh cheese

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with changes in thyroid function	thyroid stimulating hormone blood level	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HDL level	high density lipoproteins blood level	3 months
selenium	selenium blood level	3 months
IL-6	Interleukina-6 blood level	3 months
Fecal calprotectin	Fecal calprotectin feces level	3 months

Collaborators and Investigators

• Sponsor: Cooperativas Lacteas Unidas
• Collaborators: Galician South Health Research Institute
• Investigators: Principal Investigator: Maria Reyes Pérez- Fernández, PhD, Galicia sur sanitary research institute

Publications and helpful links

General 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.
• 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.

Helpful Links

• Article preprint magazine Nutrition Hospitalaria

Study record dates

Study Major Dates

• Study Start (Anticipated): September 6, 2021
• Primary Completion (Anticipated): December 30, 2021
• Study Completion (Anticipated): May 30, 2022

Study Registration Dates

• First Submitted: August 13, 2021
• First Submitted That Met QC Criteria: August 20, 2021
• First Posted (Actual): August 24, 2021

Study Record Updates

• Last Update Posted (Actual): August 24, 2021
• Last Update Submitted That Met QC Criteria: August 20, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Hypothyroidism; women; selenium
• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases; Hypothyroidism
• Other Study ID Numbers: CLUN-20191005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No