A Study to Evaluate the Efficacy of VL-NL-02 on Sleep Quality.

A Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Efficacy of VL-NL-02 on Sleep and Mood.

The goal of this clinical trial is to study the impact of VL-NL-02 in improving sleep quality, restorative sleep complaints, quality of life, stress levels, and sleep stages.

48 participants are expected to be randomized in a ratio of 1:1 to receive either VL-NL-02 or placebo and will be assigned a unique randomization code. Each group will have at least 20 completed participants after accounting for a dropout/withdrawal rate of 17%. The intervention duration for all the study participants is 21 days.

Participants will be asked to fill multiple questionnaires to assess sleep quality and mood imbalance.

Inclusion Criteria:

• Individuals aged between ≥ 18 and ≤ 50 years with a moderately active lifestyle as assessed International Physical Activity Questionnaire - Short form (IPAQ - SF)
• Individuals with mild to moderate sleeping issues as assessed by an ISI score of ≥ 8 and ≤ 21
• Individuals with a history of at least 3 episodes of sleep disturbances in the last month.
• Individuals with a Fasting Blood glucose (FBG) ≤ 125 mg/dl
• All individuals who are free from use of sleeping pills for at least 4 weeks before screening
• Individuals with normal levels of laboratory parameters: Liver profile, Lipid profile and kidney profile. [Refer to section 3.7.3 for details on parameters included and reference ranges.]
• Individuals with no more than once per week use of pain-relieving medications.
• Individuals with body mass index between ≥18 and ≤ 30 kg/m2.
• Typical bedtime between 9 PM and 11 PM.
• Individuals willing to abstain from digital activity 3 hours prior to the PSG analysis
• Willing to maintain current dietary pattern, activity level, and stable body weight for the duration of the study, and refrain from any drastic lifestyle changes.

Exclusion Criteria:

• FBG > 125 mg/dl

• Individuals diagnosed with hypertension.

• Individuals having a systolic blood pressure ≥140 mm Hg and diastolic blood pressure ≥ 90 mm Hg.

• Individuals diagnosed with Type I and Type II Diabetes Mellitus.

• Sleep disorder is secondary to another health problem such as restless leg syndrome, post-operative state etc.

• Individuals diagnosed with insomnia.

• Consumption of hypnotic drugs (<3 months before inclusion)

• Individuals taking any other sleep promoting supplements and are unwilling to stop taking those supplements for the duration of the study period

• Individuals with history of sleepwalk

• Individuals who have bad dreams 2 or more times a week.

• Individuals who are inclined to the lifestyle factors - such as jet lag, night workers and rotational shift work.

• Individuals who currently, or in the past 6 months suffered from any mental-health disorder

• Individuals who were taking psychotropic medication, herbal preparation, antidepressants, steroids, antihistamines, narcotics or any other illicit drugs in the last three months.

• Individuals diagnosed with chronic medical conditions - such as heart problems, Gastro-intestinal, hepatic, respiratory, psychiatric, kidney, or cardiovascular disorder (<3 months before inclusion), and chronic pain since last 6 months.

• Recent (within 3 months before inclusion) change in lifestyle (food, sport and drug).

• Individuals who are regular smokers and/or consume any form of tobacco.

• Addiction, history of addiction, and/or substance abuse (tobacco, nicotine etc.).

• Heavy drinkers as defined by:

  1. For men, consuming more than 4 drinks on any day or more than 14 drinks/week
  2. For women, consuming more than 3 drinks on any day or more than 7 drinks/week

• Exaggerated consumption of tea (≥500 mL per day), coffee (≥400 mL per day), or energy drink (≥250 mL per day),

• Individuals on dietary supplements

• Pregnant or lactating woman,

• Lifestyle habits which would modify the wake-sleep rhythm or which was expected to be modified during the study period (e.g., night work)

• Known allergy to mushroom.