Nutritional Trial With Probiotic Fortified Milk in Women Affected by Insomnia

NACompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

November 20, 2015

Primary Completion Date

July 31, 2016

Study Completion Date

August 31, 2017

Conditions
Sleep Disorders
Interventions
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.

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."

Trial Locations (1)

40126

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

All Listed Sponsors
lead

University of Bologna

OTHER

NCT03985228 - Nutritional Trial With Probiotic Fortified Milk in Women Affected by Insomnia | Biotech Hunter | Biotech Hunter