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

NCT05372900 | Completed DMC

• 1 other identifier: 21.03.DAI
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep

Keywords

Subjective sleep complaints

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (12)

• Changes in self-reported sleep quality via Actigraphy

  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)

• Changes in self-reported sleep quality via 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)

• Changes in self-reported sleep quality via ESS

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

• Glycemia

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

• Mood states, alertness, and sleepiness via BMIS

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

Other Outcomes (7)

• Cortisol levels in the morning

  Day 24 (V4), Day 28 (V5), Day 66 (V7), Day 80 (V8)

• Melatonin synthesis marker (6-sulfatoxymelatonin)

  Day 24 (V4), Day 28 (V5), Day 66 (V7), Day 80 (V8)

• Assess effect of sleep hygiene behaviors and life events on sleep patterns

  Visit 0 (pre Day1), Day 23, Day 65

Study Arms (2)

Test - Control product

EXPERIMENTAL

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).

Other: Test Product; Other: Control Product

Control - Test product

EXPERIMENTAL

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).

Other: Test Product; Other: Control Product

Interventions

Test Product OTHER

Whey Protein Isolate with Mulberry leaf extract

Control - Test product; Test - Control product

Control Product OTHER

Wheat Protein Hydrolysate

Control - Test product; Test - Control product

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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 .
• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

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

Singapore, 117549, Singapore

Location

Related Publications (1)

• 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.

  PMID: 40072601 DERIVED

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Michael Chee

  National University of Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: May 13, 2022
• Study Start: March 23, 2022
• Primary Completion: December 5, 2022
• Study Completion: December 12, 2022
• Last Updated: July 13, 2023

Record last verified: 2023-07

Locations

SG (1)