Research and Development

At Somnaceutics we undertake a range of activities from initial product conceptualisation and concept and clinical testing through to final market commercialisation with our partners and customers.

The development and commercialisation of our proprietary Sleep Milk product involved:

Identification of peptide and herd selection

  • Large scale herd DNA profiling to identify and select cows containing the sleep enhancing peptide. Approx 10-15% of New Zealand cows contain the desired peptide profile.
  • Special herds grouped for farming and milking.

Process establishment and testing

  • A proprietary process was developed that naturally modifies the milk peptides. The purpose of the modification is for improved peptide availiablity and activity.
  • Process assay developed to standardise the action for peptide modification.
  • Pilot production trials conducted to produce a representative product for analysis and clinical trial testing.

Clinical Trials

An indepedant clinical study was performed in New Zealand under the supervision of a medical clinician. The purpose was to examine the effects of the peptide enhanced and specially processed milk on sleep quality(modified milk).

The study used a randomised double blind crossover design. Subjects underwent polysomnography (PSG) on 3 consecutive nights. The first night was a baseline and on the second and third nights subjects were randomised with the normal milk 15 minutes before retiring, or the modified milk. PSG’s were scored according to American Academy of Sleep Medicine guidelines.

The study was conducted in a sleep laboratory and in the home using polysomnography a device which measures sleep and is commonly used to diagnose sleep disorders. The device records brain activity and measures the duration of light sleep, deep sleep and REM sleep. Good quality sleep is associated with greater proportions of deep and REM sleep. It also measures the number of arousals, which are brief periods of light sleep, and which increase during restless or poor quality sleep.

Comment

The results showed that the modified milk had a statistically significant improvement in sleep quality when compared to baseline and normal milk. In particular, there was a clinically significant increase in the percentage of REM sleep when subjects used modified milk (p=0.03) and a reduction in the number of arousals.

The positive indications from this study and other annectoctal comments from users led to the confidence to further develop and test market the product with a large consumer base.

Final product formulation and ingredient blending

  • Based on in-market research and consumer feedback a final product formulation and organoleptic characteristics were developed.
    • 98% of the lactose was removed. Make accessible to the high number of people with lactose intolerance.
    • For convenience and ease of use, the powder formulation has good dispersion and solubility.
    • Low fat.
    • No added sugar, or preservatives
  • Flavour developed for local taste preferences and profile. Either natural or nature identical flavours used and natural zero calorie sweetener (fruit sweetness - luo Han Guo).
  • High quality Functional and nutritional ingredients added that provide synergistic and complimentary benefits e.g. Magnesium to help with calcium absorbption and utilisation
  • Packed into single serve gas flushed foil sachets to ensure product freshness and quality.

Large scale consumer trial

  • A trial launch of the product marketed under the brand 'Sleep time' was released in Taiwan through New Image direct selling distributors. Sleep time sold out within 30 minutes.
  • Launch was supported with comprehensive education and training. Users were provided with and requested to complete sleep diaries, questionnares covering pre and post use and product feedback and reaction.
  • Demand for the product was stunning, with survey and questionnare results supporting the positive reception. Highlights include:
  • Of the 144 respondents 88% reported a significant improvement in sleep quality including daytime alertness and energy
  • 94% stated they would recommend to others
  • 76% of respondents rated the product 7 (out of 10) or above for flavour and appeal. 22% rated it as 9 and 10.