Nutritional Trial With Probiotic Fortified Milk in Women Affected by Insomnia (Prosit)
|ClinicalTrials.gov Identifier: NCT03985228|
Recruitment Status : Completed
First Posted : June 13, 2019
Last Update Posted : June 13, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Sleep Disorders||Dietary Supplement: Fortified milk Dietary Supplement: Placebo milk||Not Applicable|
Sleep disorders and, in particular, insomnia, are quite common conditions in over 55 population, especially among women. Insomnia becomes a chronic pathology when the difficulty in initiating or maintaining sleep occurs more times a week for several months and is associated to a constant feeling of fatigue, concentration problems, mood disorders and social and family troubles severely impairing the quality of life. In according to the sleep hygiene guidelines, the therapeutic treatments for insomnia include drugs (benzodiazepines, non-benzodiazepines, antidepressants) with often not fully satisfactory results for the patient and entailing a series of side effects, such as daytime sleepiness, lack of attention and energy in addition to mental confusion. Recently, some researches in neurological field have shown that disorders affecting central nervous system, as well as sleep and circadian rhythm disruption, can be associated to specific alteration of the gut microbiota. The enteric nervous system has been referred to as a "second brain" able to interact with the central nervous system impinging upon higher cognitive functions through a bidirectional communication system known as gut-brain axis. The gut microflora plays a crucial role in gut-brain axis, modulating stress response through the Hypothalamic-Pituitary-Adrenal axis and thus influencing memory, mood, cognition and sleep architecture. Therefore, a non-pharmacological intervention aimed to improve gut microbiota and the inflammatory bowel conditions could be an effective strategy to counteract insomnia. In the framework of Pros.IT project, the Granarolo S.p.A. in collaboration with the University of Bologna has developed a milk enriched with different micronutrients (vitamins, ω-3 fatty acids, prebiotics, curcumin) and "infant-type" probiotics isolated from human milk and endowed with immunomodulating activity. This supplementation should improve the overall health status, and in particular the plant extracts, prebiotics and probiotics with anti-inflammatory and immunomodulatory activities should ameliorate significantly sleep quality and stress perception through the modulation of gut microbiota and gut-brain axis.
The main goal of this study is to evaluate the effect of the administration of a functional milk reinforced with probiotics (250ml/die), vitamins and other micronutrients on sleep of patients suffering from chronic insomnia. An objective assessment it requires a value at least higher than 3% of increase of the sleep efficiency, since the 3% is the percentage of improvement recognized to the common drugs against insomnia. The study is randomized, double-blind, placebo-controlled trial.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Promotion of Consumer's Health: Nutritional Enhancement/Valorization of Agrofood Italian Traditional Products (PROS.IT)|
|Study Start Date :||November 20, 2015|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||August 31, 2017|
Experimental: Fortified milk
The subjects assumed daily 250 ml of fortified milk for 12 weeks.
Dietary Supplement: Fortified milk
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.
Other Name: golden milk
Placebo Comparator: Placebo milk
The subjects assumed daily 250 ml of placebo milk for 12 weeks.
Dietary Supplement: Placebo milk
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.
- Self reported quality of sleep [ Time Frame: Change from baseline Sleep evaluation at 12 weeks milk intake ]Sleep quality assessed by questionnaires
- Measured quality of sleep [ Time Frame: Change from baseline Sleep evaluation at 12 weeks milk intake ]assessed by actigraph
- Levels of stress [ Time Frame: 12 weeks ]Stress was evaluated by PSS questionnaire and 24-h urinary cortisol levels
- Inflammatory status [ Time Frame: 12 weeks ]Dosage in plasma of the following cytokines: IL-1β, IL-4, IL-6, IL-10, IL-17A, IL-17F, IL-21, IL-22, IL-23, IL-25, IL-31, IL-33, IFN-γ, sCD40L, TNF-α, IL-17 A/F by Elisa immunoassay.
- Evalution of glycomics [ Time Frame: 12 weeks ]Plasmatic N-glycans by capillary electrophoresis (DSA-FACE).
- Levels of anxiety [ Time Frame: 12 weeks ]Stress was evaluated by STAI-Y2
- Levels of depression. [ Time Frame: 12 weeks ]Stress was evaluated by BDI-II questionnaire
- Evalution of epigenetic [ Time Frame: 12 weeks ]Epigenetic analysis of ELOVL2, FHL2, PENK genes by "Sequenom"
- Gut Microbiota composition [ Time Frame: 12 weeks ]Analysis of gut-microbiota composition by 454 Pyrosequencing of the V4 region of the 16S rRNA gene.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03985228
|University of Bologna-Department of Speciality, Diagnostic and Experimental Medicine|
|Bologna, Italy, 40126|
|Principal Investigator:||Claudio Franceschi, MD||University of Bologna|