Nutritional Trial With Probiotic Fortified Milk in Women Affected by Insomnia

NCT03985228 | Completed

• 1 other identifier: MIUR prot.n.257/Ric.
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The study "Nutritional Trial With Probiotic Fortified Milk in Women Affected by Insomnia" is a part of a complex and multi-sectoral development research project (PROS.IT) with the participation of University Research Institutes and small/medium Italian enterprises. The general objective of the Project is to promote the collaboration between the best scientific research, both epidemiological and experimental, and the most advanced technologies to develop fortified foods that meeting the specific nutritional requirements of adult consumers. This objective will be achieved by the nutritional improvement of primary production, the development of innovative functional foods at high added value, in addition to traditional products functionalized, which are peculiar of the Italian local districts.

Conditions

Sleep Disorders

Keywords

golden milk, insomnia, gut-brain axis

Outcome Measures

Primary Outcomes (2)

• Self reported quality of sleep

  Sleep quality assessed by questionnaires

  Change from baseline Sleep evaluation at 12 weeks milk intake

• Measured quality of sleep

  assessed by actigraph

  Change from baseline Sleep evaluation at 12 weeks milk intake

Secondary Outcomes (7)

• Levels of stress

  12 weeks

• Inflammatory status

  12 weeks

• Evalution of glycomics

  12 weeks

• Levels of anxiety

  12 weeks

• Levels of depression.

  12 weeks

Study Arms (2)

Fortified milk

EXPERIMENTAL

The subjects assumed daily 250 ml of fortified milk for 12 weeks.

Dietary Supplement: Fortified milk

Placebo milk

PLACEBO COMPARATOR

The subjects assumed daily 250 ml of placebo milk for 12 weeks.

Dietary Supplement: Placebo milk

Interventions

Fortified milk DIETARY_SUPPLEMENT

Ultra high temperature UHT, partly-skimmed milk (1% fat), highly digestible (lactose \<0.01%), enriched in whey protein (5%) and calcium (0.24%), supplemented with unsaturated fatty acids omega-3 (DHA + EPA), vitamins (D, B12, B6, B9, E, C), prebiotics (FOS) and phyto curcuminoids (sunflower lecithin). Milk had to be associated with a packet of lyophilized and concentrated probiotics (Bifidobacteria infant-type and / or Lactobacilli), at the time of consumption. Milk and probiotics had been produced or supplied by Granarolo s.p.a.

Also known as: golden milk

Fortified milk

Placebo milk DIETARY_SUPPLEMENT

Ultra high temperature UHT, partly-skimmed milk (1% fat), highly digestible (lactose \<0.01%) with standard proteins of milk (3.1%) and color additive "quantum satis". Milk had to be associated with a packet of maltodextrin "Food Grade", at the time of consumption. Milk and maltodextrin had been produced or supplied by Granarolo s.p.a.

Placebo milk

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with an age between 55 and 70 years old, only females, free-living, affected by chronic insomnia defined according to the criteria of the International Classification of Sleep Disorders (2014).

You may not qualify if:

• Allergy or intolerance to cow's milk. Use of Benzodiazepines, "Z drugs" or anti-depressive drugs during the three months preceding the start of the trial. Celiac disease and other intestinal malabsorption or inflammatory bowel diseases (Crohn's disease and ulcerative colitis). Chronic therapy with anticoagulant, corticosteroid, anticancer drugs and immunosuppressants. Diabetes type I and type II, chronic viral hepatitis, neurological disorders or dementia, cancer, poor prognosis disease in the short term. Use of anti-inflammatory drugs or inflammatory-infective events within 7 days before the start of the trial and use of antibiotics or vaccinations within 30 days before.

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (1)

University of Bologna-Department of Speciality, Diagnostic and Experimental Medicine

Bologna, 40126, Italy

Location

MeSH Terms

Conditions

Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Claudio Franceschi, MD

  University of Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor emeritus

Study Record Dates

• First Submitted: July 22, 2016
• First Posted: June 13, 2019
• Study Start: November 20, 2015
• Primary Completion: July 1, 2016
• Study Completion: August 31, 2017
• Last Updated: June 13, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)