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

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.

Study Overview

• Status: Completed
• Conditions: Sleep
• Intervention / Treatment: Other: Test Product; Other: Control Product

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

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 117549
    • Centre for Sleep and Cognition, NUS Yong Loo Lin School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Other: Test Product; Whey Protein Isolate with Mulberry leaf extract; Other: Control Product; Wheat Protein Hydrolysate
Experimental: 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).	Other: Test Product; Whey Protein Isolate with Mulberry leaf extract; Other: Control Product; Wheat Protein Hydrolysate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in self-reported sleep quality via Actigraphy	Changes in WASO & total sleep duration	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	Changes in self-reported sleep quality measured through questionnaire Karolinska Sleep Diary (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	Changes in self-reported sleep quality measured through questionnaire Epworth Sleepiness Scale (ESS)	Day 1 (V1) & Day 15 (V2), Day 23, 31, 37, 45, 65, 73, 79, 87)
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	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	Questionnaire Brief Mood Introspection Scale (BMIS)	Day 22 (V3), Day 23 to Day 37, Day 65, Day 66 (V7) to Day 79
Mood states, alertness, and sleepiness via KSS	Questionnaire Karolinska Sleepiness Scale (KSS)	Day 22 (V3), Day 23 to Day 37, Day 65, Day 66 (V7) to Day 79
Mood states, alertness, and sleepiness via POMS-SF 2	Questionnaire Profile of Mood States - Short Form 2 (POMS-SF 2)	Day 22 (V3), Day 23, 31, 37, 65, 73, 79
Cognition tasks via Immediate & delayed free recall	Immediate & delayed free recall	Day 22 (V3), Day 23, 37, 65, 79
Cognition task PVT	Psychomotor Vigilance Task (PVT)	Day 22 (V3), Day 23, 31, 37, 65, 73, 79
Cognition test N-back task	N-back task	Day 22 (V3), Day 23, 31, 37, 65, 73, 79
Cognition test Go/No-Go task	Go/No-Go task	Day 22 (V3), Day 23, 31, 37, 65, 73, 79
Cognition task NASA-TLX	NASA task load index (NASA-TLX)	Day 22 (V3), Day 23, 31, 37, 65, 73, 79

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cortisol levels in the morning	Cortisol levels in saliva as an objective index of stress	Day 24 (V4), Day 28 (V5), Day 66 (V7), Day 80 (V8)
Melatonin synthesis marker (6-sulfatoxymelatonin)	6-sulfatoxymelatonin levels in urine as an index of melatonin synthesis, which will be reported as a ratio of urinary 6-sulfatoxymelatonin to urinary creatinine.	Day 24 (V4), Day 28 (V5), Day 66 (V7), Day 80 (V8)
Assess effect of sleep hygiene behaviors and life events on sleep patterns	Sleep hygiene questionnaire	Visit 0 (pre Day1), Day 23, Day 65
Change in sleep efficiency, calculated as '(total time asleep / time in bed) X 100; sleep efficiency above 85% is considered good	Measure of sleep parameter using the commercial sensor Oura ring	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 (mins), measured in time needed to fall asleep after going to bed.	Measure of sleep parameter using the commercial sensor Oura ring	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 WASO (actigraphy) - proportion of people reaching < 30 mins	Measure of sleep parameter using the commercial sensor Oura ring	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 total sleep duration (mins; actigraphy)	Measure of sleep parameter using the commercial sensor Oura ring.	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)

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Investigators: Principal Investigator: Michael Chee, National University of Singapore

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2022
• Primary Completion (Actual): December 5, 2022
• Study Completion (Actual): December 12, 2022

Study Registration Dates

• First Submitted: December 2, 2021
• First Submitted That Met QC Criteria: May 12, 2022
• First Posted (Actual): May 13, 2022

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: July 11, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Subjective sleep complaints
• Other Study ID Numbers: 21.03.DAI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No