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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-23

Study Completion Date

2022-12-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Performance, Mood, and Brain and Metabolic Functions During Different Sleep Schedules

NCT04731662

Sleep Sleep Restriction

COMPLETED NA

Monitoring Sleep and Glucose Among University Students

NCT04880629

Sleep

COMPLETED NA

Personalising Children's Screen Use Reduction for Better Sleep, Mental, and Brain Health

NCT05956392

Screen-use Reduction + Sleep Extension Free-living

RECRUITING NA

Sleep Deprivation Study

NCT05560620

Cognitive Change Sleep Deprivation Caffeine

COMPLETED NA

An Observational Pilot Study to Characterize Relationships Between Self-reported Information, Game Performance, and Passive Physiology Measures Throughout a Daily Cycle

NCT02376569

Energy and Cognition

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Sleep

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Test - 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).

Group Type EXPERIMENTAL

Test Product

Intervention Type OTHER

Whey Protein Isolate with Mulberry leaf extract

Control Product

Intervention Type OTHER

Wheat Protein Hydrolysate

Control - 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).

Group Type EXPERIMENTAL

Test Product

Intervention Type OTHER

Whey Protein Isolate with Mulberry leaf extract

Control Product

Intervention Type OTHER

Wheat Protein Hydrolysate

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Test Product

Whey Protein Isolate with Mulberry leaf extract

Intervention Type OTHER

Control Product

Wheat Protein Hydrolysate

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes