CompletedNot Applicable

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

Singapore43 participantsStarted 2022-03-23

Plain-language 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.

Who can participate

Age range25 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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)

Exclusion criteria

✕. 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
✕. 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 .

What they're measuring

Changes in sleep efficiency (actigraphy)

Timeframe: 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)

Change in sleep latency (actigraphy)

Timeframe: 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)

Trial details

NCT IDNCT05372900

SponsorSociété des Produits Nestlé (SPN)

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-12-05

View on ClinicalTrials.gov More Sleep trials

Who can participate

Age range25 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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)

Exclusion criteria

✕. 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
✕. 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 .

What they're measuring

Changes in sleep efficiency (actigraphy)

Timeframe: 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)

Change in sleep latency (actigraphy)

Timeframe: 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)