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SleepNCT05372900

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

A study testing Test Product in people with Sleep, run by Société des Produits Nestlé (SPN) at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 25 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Sleep
What is being tested?
Test Product
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteSingapore
Study dates
23 Mar 2022to 12 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • Diagnosed food allergy or other intolerance to the investigational products, control products and standardized meals
  • 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
  • Significant medication history including use of corticosteroid in oral or systemic format and antidepressants (e.g. Selective Serotonin Reuptake Inhibitors, Monoamine Oxidase Inhibitors)
  • 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).
  • Parents of children less than 12 months of age, which is a known factor of sleep disturbances.
  • Peri- and post-menopausal women
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  • Known or diagnosed sleep disorders
  • 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 .
  • Chronic exercisers, defined as subjects exercising > 1 h/day for at least 5 days/week
  • Caffeine consumption over the recommended daily limit (above 400 mg; equivalent to approximately 4-5 cups of coffee)
  • Substance abuse including over the limit alcohol consumption (2 standard drinks/day for males, 1 standard drink/day for female)
  • Cigarette and Tobacco Smokers
  • Intake of dietary supplements that may affect sleep conditions (e.g. melatonin, theanine, tryptophan, GABA, magnesium, zinc)
  • Subjects not willing and/or not able to comply with scheduled visits and the requirements of the study protocol.
  • Participating in other clinical trials or had been participating in other clinical trial in the preceding 1 month.
  • Subjects belonging to a household where at least one other person is taking part in the trial.

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • Centre for Sleep and Cognition, NUS Yong Loo Lin School of Medicine

    Singapore, 117549

Other trials in Singapore

About this study

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.

Read the 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
Conditions
Sleep
Being tested
Test Product, Control Product
Keywords
Subjective sleep complaints

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Test ProductOther

    Whey Protein Isolate with Mulberry leaf extract

  • Control ProductOther

    Wheat Protein Hydrolysate

Study groups in NCT05372900
Study groupRoleWhat they receive
Test - Control productExperimentalSubject 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).
Receives: Other: Test Product; Other: Control Product
Control - Test productExperimentalSubject 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).
Receives: Other: Test Product; Other: Control Product

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in sleep efficiency (actigraphy)

    Calculated as '(total time asleep / time in bed) X 100; sleep efficiency above 85% is considered good.

    Measured: 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)

  2. Change in sleep latency (actigraphy)

    Measured as the amount of time it takes subjects to fall asleep after going to bed (in minutes)

    Measured: 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 (12)

  1. Changes in self-reported sleep quality via Actigraphy

    Changes in WASO \& total sleep duration

    Measured: 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)

  2. Changes in self-reported sleep quality via KSD

    Changes in self-reported sleep quality measured through questionnaire Karolinska Sleep Diary (KSD)

    Measured: 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)

  3. Changes in self-reported sleep quality via ESS

    Changes in self-reported sleep quality measured through questionnaire Epworth Sleepiness Scale (ESS)

    Measured: Day 1 (V1) & Day 15 (V2), Day 23, 31, 37, 45, 65, 73, 79, 87)

  4. 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

    Measured: Day 1 (V1) to Day 14, Day 24 (V4) to Day 37, Day 66 (V7) 7 to Day 79

  5. Mood states, alertness, and sleepiness via BMIS

    Questionnaire Brief Mood Introspection Scale (BMIS)

    Measured: Day 22 (V3), Day 23 to Day 37, Day 65, Day 66 (V7) to Day 79

  6. Mood states, alertness, and sleepiness via KSS

    Questionnaire Karolinska Sleepiness Scale (KSS)

    Measured: Day 22 (V3), Day 23 to Day 37, Day 65, Day 66 (V7) to Day 79

  7. Mood states, alertness, and sleepiness via POMS-SF 2

    Questionnaire Profile of Mood States - Short Form 2 (POMS-SF 2)

    Measured: Day 22 (V3), Day 23, 31, 37, 65, 73, 79

  8. Cognition tasks via Immediate & delayed free recall

    Immediate \& delayed free recall

    Measured: Day 22 (V3), Day 23, 37, 65, 79

  9. Cognition task PVT

    Psychomotor Vigilance Task (PVT)

    Measured: Day 22 (V3), Day 23, 31, 37, 65, 73, 79

  10. Cognition test N-back task

    N-back task

    Measured: Day 22 (V3), Day 23, 31, 37, 65, 73, 79

  11. Cognition test Go/No-Go task

    Go/No-Go task

    Measured: Day 22 (V3), Day 23, 31, 37, 65, 73, 79

  12. Cognition task NASA-TLX

    NASA task load index (NASA-TLX)

    Measured: Day 22 (V3), Day 23, 31, 37, 65, 73, 79

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2022
  2. Study start23 Mar 2022
  3. Primary completion5 Dec 2022
  4. Study completion12 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
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.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05372900
Sponsor's protocol ID
21.03.DAI
Status last verified
Jul 2023
First submitted
2 Dec 2021
Last updated
13 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Soon CS, Thota R, Owen L, Tian L, Martin FP, Mantantzis K, Cherta-Murillo A, Campos VC, Chkroun C, Lavalle L, Hartweg M, St-Onge MP, Chee MWL, Darimont C. Mulberry leaf extract combined with tryptophan improves sleep and post wake mood in adults with sleep complaints - A randomized cross-over study. Eur J Nutr. 2025 Mar 12;64(3):124. doi: 10.1007/s00394-025-03643-8.

    PubMed 40072601

Questions about this trial

What is this clinical trial studying?

A study testing Test Product in people with Sleep, run by Société des Produits Nestlé (SPN) at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in sleep efficiency (actigraphy) (time frame: 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05372900, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2023.

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