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

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05372900
• Other study ID #: 21.03.DAI
• Status: Completed
• Phase: N/A
• Start date: March 23, 2022
• Est. completion date: December 12, 2022

Study information

• Verified date: July 2023
• Source: Société des Produits Nestlé (SPN)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 12, 2022
• Est. primary completion date: December 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sleep

Intervention

Other:
• Test Product
Whey Protein Isolate with Mulberry leaf extract
• Control Product
Wheat Protein Hydrolysate

Locations

Country	Name	City	State
Singapore	Centre for Sleep and Cognition, NUS Yong Loo Lin School of Medicine	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Société des Produits Nestlé (SPN)

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cortisol levels in the morning	Cortisol levels in saliva as an objective index of stress	Day 24 (V4), Day 28 (V5), Day 66 (V7), Day 80 (V8)
Other	Melatonin synthesis marker (6-sulfatoxymelatonin)	6-sulfatoxymelatonin levels in urine as an index of melatonin synthesis, which will be reported as a ratio of urinary 6-sulfatoxymelatonin to urinary creatinine.	Day 24 (V4), Day 28 (V5), Day 66 (V7), Day 80 (V8)
Other	Assess effect of sleep hygiene behaviors and life events on sleep patterns	Sleep hygiene questionnaire	Visit 0 (pre Day1), Day 23, Day 65
Other	Change in sleep efficiency, calculated as '(total time asleep / time in bed) X 100; sleep efficiency above 85% is considered good	Measure of sleep parameter using the commercial sensor Oura ring	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)
Other	Change in sleep latency (mins), measured in time needed to fall asleep after going to bed.	Measure of sleep parameter using the commercial sensor Oura ring	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)
Other	Change in WASO (actigraphy) - proportion of people reaching < 30 mins	Measure of sleep parameter using the commercial sensor Oura ring	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)
Other	Change in total sleep duration (mins; actigraphy)	Measure of sleep parameter using the commercial sensor Oura ring.	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)
Primary	Changes in sleep efficiency (actigraphy)	Calculated as '(total time asleep / time in bed) X 100; sleep efficiency above 85% is considered good.	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)
Primary	Change in sleep latency (actigraphy)	Measured as the amount of time it takes subjects to fall asleep after going to bed (in minutes)	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	Changes in self-reported sleep quality via Actigraphy	Changes in WASO & total sleep duration	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	Changes in self-reported sleep quality via KSD	Changes in self-reported sleep quality measured through questionnaire Karolinska Sleep Diary (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)
Secondary	Changes in self-reported sleep quality via ESS	Changes in self-reported sleep quality measured through questionnaire Epworth Sleepiness Scale (ESS)	Day 1 (V1) & Day 15 (V2), Day 23, 31, 37, 45, 65, 73, 79, 87)
Secondary	Glycemia	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	Day 1 (V1) to Day 14, Day 24 (V4) to Day 37, Day 66 (V7) 7 to Day 79
Secondary	Mood states, alertness, and sleepiness via BMIS	Questionnaire Brief Mood Introspection Scale (BMIS)	Day 22 (V3), Day 23 to Day 37, Day 65, Day 66 (V7) to Day 79
Secondary	Mood states, alertness, and sleepiness via KSS	Questionnaire Karolinska Sleepiness Scale (KSS)	Day 22 (V3), Day 23 to Day 37, Day 65, Day 66 (V7) to Day 79
Secondary	Mood states, alertness, and sleepiness via POMS-SF 2	Questionnaire Profile of Mood States - Short Form 2 (POMS-SF 2)	Day 22 (V3), Day 23, 31, 37, 65, 73, 79
Secondary	Cognition tasks via Immediate & delayed free recall	Immediate & delayed free recall	Day 22 (V3), Day 23, 37, 65, 79
Secondary	Cognition task PVT	Psychomotor Vigilance Task (PVT)	Day 22 (V3), Day 23, 31, 37, 65, 73, 79
Secondary	Cognition test N-back task	N-back task	Day 22 (V3), Day 23, 31, 37, 65, 73, 79
Secondary	Cognition test Go/No-Go task	Go/No-Go task	Day 22 (V3), Day 23, 31, 37, 65, 73, 79
Secondary	Cognition task NASA-TLX	NASA task load index (NASA-TLX)	Day 22 (V3), Day 23, 31, 37, 65, 73, 79