Nutritional Intervention to Improve Sleep Quality and Improve Next-day Mood and Cognitive Benefits

Not Applicable

Completed

• Conditions: Sleep
• Interventions: Other: Test Product; Other: Control Product

• Registration Number: NCT05372900
• Lead Sponsor: Société des Produits Nestlé (SPN)

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

Study Timeline

• Study First Submitted: 2021-12-02
• Study Start: 2022-03-23
• Study First Submitted QC: 2022-05-12
• Study First Posted: 2022-05-13
• Primary Completion: 2022-12-05
• Study Completion: 2022-12-12
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-11
• Last Update Posted: 2023-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test - Control product	Test Product	Subject will start with consuming the test product daily for total 14 days (during intervention 1 period). After the 4 - 6 weeks wash out, subject will then consume the control product daily for total 14 days (during intervention period 2).
Test - Control product	Control Product	Subject will start with consuming the test product daily for total 14 days (during intervention 1 period). After the 4 - 6 weeks wash out, subject will then consume the control product daily for total 14 days (during intervention period 2).
Control - Test product	Control Product	Subject will start with consuming the control product daily for total 14 days (during intervention 1 period). After the 4 - 6 weeks wash out, subject will then consume the test product daily for total 14 days (during intervention period 2).
Control - Test product	Test Product	Subject will start with consuming the control product daily for total 14 days (during intervention 1 period). After the 4 - 6 weeks wash out, subject will then consume the test product daily for total 14 days (during intervention period 2).

Primary Outcome Measures

Name	Time	Method
Changes in sleep efficiency (actigraphy)	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)	Calculated as '(total time asleep / time in bed) X 100; sleep efficiency above 85% is considered good.
Change in sleep latency (actigraphy)	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)	Measured as the amount of time it takes subjects to fall asleep after going to bed (in minutes)

Secondary Outcome Measures

Name	Time	Method
Changes in self-reported sleep quality via KSD	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)	Changes in self-reported sleep quality measured through questionnaire Karolinska Sleep Diary (KSD)
Cognition task PVT	Day 22 (V3), Day 23, 31, 37, 65, 73, 79	Psychomotor Vigilance Task (PVT)
Cognition task NASA-TLX	Day 22 (V3), Day 23, 31, 37, 65, 73, 79	NASA task load index (NASA-TLX)
Changes in self-reported sleep quality via Actigraphy	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)	Changes in WASO \& total sleep duration
Changes in self-reported sleep quality via ESS	Day 1 (V1) & Day 15 (V2), Day 23, 31, 37, 45, 65, 73, 79, 87)	Changes in self-reported sleep quality measured through questionnaire Epworth Sleepiness Scale (ESS)
Mood states, alertness, and sleepiness via KSS	Day 22 (V3), Day 23 to Day 37, Day 65, Day 66 (V7) to Day 79	Questionnaire Karolinska Sleepiness Scale (KSS)
Mood states, alertness, and sleepiness via BMIS	Day 22 (V3), Day 23 to Day 37, Day 65, Day 66 (V7) to Day 79	Questionnaire Brief Mood Introspection Scale (BMIS)
Cognition test Go/No-Go task	Day 22 (V3), Day 23, 31, 37, 65, 73, 79	Go/No-Go task
Glycemia	Day 1 (V1) to Day 14, Day 24 (V4) to Day 37, Day 66 (V7) 7 to Day 79	Glycemia measured by continuous glucose monitoring: * Glucose response of the evening standard meal with the test product or the control product; * Glucose excursion during the night (from time to bed to wakening); * Subsequent breakfast
Cognition tasks via Immediate & delayed free recall	Day 22 (V3), Day 23, 37, 65, 79	Immediate \& delayed free recall
Mood states, alertness, and sleepiness via POMS-SF 2	Day 22 (V3), Day 23, 31, 37, 65, 73, 79	Questionnaire Profile of Mood States - Short Form 2 (POMS-SF 2)
Cognition test N-back task	Day 22 (V3), Day 23, 31, 37, 65, 73, 79	N-back task

Trial Locations

Locations (1)

Centre for Sleep and Cognition, NUS Yong Loo Lin School of Medicine; 🇸🇬 Singapore, Singapore