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

Nestlé

Status: Completed

Conditions: Sleep

Treatments: Other: Control Product; Other: Test Product

Study type: Interventional

Funder types: Industry

Identifiers

NCT05372900

21.03.DAI

Details and patient eligibility

About

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.

Full 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

Enrollment: 43 patients

Sex: All

Ages: 25 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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43 participants in 2 patient groups

Test - Control product

Experimental group

Description:

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).

Treatment:

Other: Test Product

Other: Control Product

Control - Test product

Experimental group

Description:

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).

Treatment:

Other: Test Product

Other: Control Product