Clinical trial NCT05372900: Nutritional Intervention to Improve Sleep Quality and Improve Next-day Mood and Cognitive Benefits
Official title: Nutritional Intervention to Improve Sleep Quality and Improve Next-day Mood and Cognitive Benefits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Keywords: Subjective sleep complaints
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2022-05-13
Enrollment: 43
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a double-blind, controlled, randomized, 2-arm, cross-over, group sequential design clinical trial. Subjects will receive the two different interventions in a randomized order.
Primary purpose: OTHER

Brief summary: The study aim to test the effect of a meal complement to be taken in combination with an evening meal with a glycemic load of 55, to improve sleep quality.

Detailed description: Considering emerging evidence on the role of the macro and micro-nutrient composition of evening meals, the intervention used in this study will be designed to provide the necessary nutrients to promote sleep quality. The IP will be a low caloric nutritional solution, combining:

* Ingredients lowering glycemic response to evening meals to promote sleep quality
* a protein source rich in bioavailable tryptophan to promote sleep quality
* supporting ingredients contributing to sleep initiation

Eligibility criteria: Inclusion Criteria:

1. Willing and able provide written informed consent (in English)
2. Aged 25-50
3. BMI range from 18.5 to 24.9 kg/m2
4. Subjective sleep complaints (PSQI \> 5)

Exclusion Criteria:

1. Diagnosed food allergy or other intolerance to the investigational products, control products and standardized meals
2. Significant past medical and psychiatric history and ongoing chronic conditions for example cardiovascular disease, respiratory disease, metabolic disorder, endocrine disorder (e.g. diabetes mellitus, history of hypoglycemia), and neurological and psychiatric conditions, and conditions that the investigator deem inappropriate to enter the clinical trials
3. Significant medication history including use of corticosteroid in oral or systemic format and antidepressants (e.g. Selective Serotonin Reuptake Inhibitors, Monoamine Oxidase Inhibitors)
4. Pregnant or intending to conceive during the course of clinical trial and up to one month after trial conclusion, or not able to comply with a highly effective form of birth control or lactating during the clinical trial. Highly effective contraception includes hormonal methods, such as the contraceptive pill or implant, or an intrauterine device (IUD), or barrier methods such as diaphragm plus spermicide or condom plus spermicide. Pregnancy status will be assessed using urinary dipsticks at the beginning and end of the study period (V0 and V9).
5. Parents of children less than 12 months of age, which is a known factor of sleep disturbances.
6. Peri- and post-menopausal women
7. Known or diagnosed sleep disorders
8. Special diets, including for instance halal food preference, vegetarian, high protein or weight loss program, and diets with either too low (\< 35% daily energy from CHO; e.g., ketogenic diet, Atkins diet, zero-carb diet, low-carb paleo/Mediterranean diet, carb cycling diet) or too high carbohydrate (\>70% daily energy from CHO) content .
9. Chronic exercisers, defined as subjects exercising \> 1 h/day for at least 5 days/week
10. Caffeine consumption over the recommended daily limit (above 400 mg; equivalent to approximately 4-5 cups of coffee)
11. Substance abuse including over the limit alcohol consumption (2 standard drinks/day for males, 1 standard drink/day for female)
12. Cigarette and Tobacco Smokers
13. Intake of dietary supplements that may affect sleep conditions (e.g. melatonin, theanine, tryptophan, GABA, magnesium, zinc)
14. Subjects not willing and/or not able to comply with scheduled visits and the requirements of the study protocol.
15. Participating in other clinical trials or had been participating in other clinical trial in the preceding 1 month.
16. Subjects belonging to a household where at least one other person is taking part in the trial.

Primary outcomes:
measure: Changes in sleep efficiency (actigraphy)
timeFrame: Day 1 (V1) to Day 15 (V2), Day 22 (V3) to Day 37, Day 38 (V5) to Day 45, Day 59 (V6) to Day 65, Day 66 (V7) to Day 79, Day 80 (V8) to Day 87 (V9)
measure: Change in sleep latency (actigraphy)
timeFrame: Day 1 (V1) to Day 15 (V2), Day 22 (V3) to Day 37, Day 38 (V5) to Day 45, Day 59 (V6) to Day 65, Day 66 (V7) to Day 79, Day 80 (V8) to Day 87 (V9)
Secondary outcomes:
measure: Changes in self-reported sleep quality via Actigraphy
timeFrame: Day 1 (V1) to Day 15 (V2) , Day 22 (V3) to Day 37, Day 38 (V5) to Day 45, Day 59 (V6) to Day 65, Day 66 (V7) to Day 79, Day 80 (V8) to Day 87 (V9)
measure: Changes in self-reported sleep quality via KSD
timeFrame: Day 1 (V1), Day 15 (V2), Day 22 (V3), Day 23, Day 24 (V4) to Day 37, Day 45 and 65, Day 66 (V7) to Day 79, Day 87 (V9)
measure: Changes in self-reported sleep quality via ESS
timeFrame: Day 1 (V1) & Day 15 (V2), Day 23, 31, 37, 45, 65, 73, 79, 87)
measure: Glycemia
timeFrame: Day 1 (V1) to Day 14, Day 24 (V4) to Day 37, Day 66 (V7) 7 to Day 79
measure: Mood states, alertness, and sleepiness via BMIS
timeFrame: Day 22 (V3), Day 23 to Day 37, Day 65, Day 66 (V7) to Day 79
measure: Mood states, alertness, and sleepiness via KSS
timeFrame: Day 22 (V3), Day 23 to Day 37, Day 65, Day 66 (V7) to Day 79
measure: Mood states, alertness, and sleepiness via POMS-SF 2
timeFrame: Day 22 (V3), Day 23, 31, 37, 65, 73, 79
measure: Cognition tasks via Immediate & delayed free recall
timeFrame: Day 22 (V3), Day 23, 37, 65, 79
measure: Cognition task PVT
timeFrame: Day 22 (V3), Day 23, 31, 37, 65, 73, 79
measure: Cognition test N-back task
timeFrame: Day 22 (V3), Day 23, 31, 37, 65, 73, 79
measure: Cognition test Go/No-Go task
timeFrame: Day 22 (V3), Day 23, 31, 37, 65, 73, 79
measure: Cognition task NASA-TLX
timeFrame: Day 22 (V3), Day 23, 31, 37, 65, 73, 79
Other outcomes:
measure: Cortisol levels in the morning
timeFrame: Day 24 (V4), Day 28 (V5), Day 66 (V7), Day 80 (V8)
measure: Melatonin synthesis marker (6-sulfatoxymelatonin)
timeFrame: Day 24 (V4), Day 28 (V5), Day 66 (V7), Day 80 (V8)
measure: Assess effect of sleep hygiene behaviors and life events on sleep patterns
timeFrame: Visit 0 (pre Day1), Day 23, Day 65
measure: Change in sleep efficiency, calculated as '(total time asleep / time in bed) X 100; sleep efficiency above 85% is considered good
timeFrame: Day 1 (V1) to Day 15 (V2), Day 22 (V3) to Day 37, Day 38 (V5) to Day 45, Day 59 (V6) to Day 65, Day 66 (V7) to Day 79, Day 80 (V8) to Day 87 (V9)
measure: Change in sleep latency (mins), measured in time needed to fall asleep after going to bed.
timeFrame: Day 1 (V1) to Day 15 (V2), Day 22 (V3) to Day 37, Day 38 (V5) to Day 45, Day 59 (V6) to Day 65, Day 66 (V7) to Day 79, Day 80 (V8) to Day 87 (V9)
measure: Change in WASO (actigraphy) - proportion of people reaching < 30 mins
timeFrame: Day 1 (V1) to Day 15 (V2), Day 22 (V3) to Day 37, Day 38 (V5) to Day 45, Day 59 (V6) to Day 65, Day 66 (V7) to Day 79, Day 80 (V8) to Day 87 (V9)
measure: Change in total sleep duration (mins; actigraphy)
timeFrame: Day 1 (V1) to Day 15 (V2), Day 22 (V3) to Day 37, Day 38 (V5) to Day 45, Day 59 (V6) to Day 65, Day 66 (V7) to Day 79, Day 80 (V8) to Day 87 (V9)
Locations:
city: Singapore
country: Singapore
facility: Centre for Sleep and Cognition, NUS Yong Loo Lin School of Medicine
Study officials:
affiliation: National University of Singapore
name: Michael Chee
role: PRINCIPAL_INVESTIGATOR
References: