Effects of a Novel Supplement on Sleep, Metabolism, Body Composition and Performance

NCT05236504 | Unknown

• 1 other identifier: Bettery LifeLab4BS
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to investigate the effects of a novel dietary supplement, consisting of melatonin and magnesium in a pod (coffee machine capsule) format, on sleep quality, stress, mood, sleepiness, biological rhythms, metabolism, body composition and performance, in individuals with sleep disturbances according with the Pittsburgh Sleep Quality Index. A randomized, double-blind, crossover trial will be conducted to compare the effects of the melatonin and magnesium-containing supplement against a placebo. The protocol comprises 4 weeks of supplementation with an experimental or placebo condition, with a week-long washout period. Biochemical markers of sleep and stress, actigraphy for sleep patterns and sleep hygiene, resting metabolic rate, food and fluid intake, body composition, and handgrip strength measures will be evaluated at baseline and 4 weeks post each randomly assigned intervention. The working hypothesis is that this innovative supplement will provide greater objective and subjective improvements regarding sleep patterns and quality, overall mood, biochemical markers of stress, resting metabolic rate, energy intake, body composition and strength, than the placebo comparator, due to the synergic effects of melatonin and magnesium.

Conditions

Sleep Hygiene; Sleep Disturbance

Keywords

Melatonin; Magnesium; Supplementation; Sleep; Resting metabolic rate; Body composition; Handgrip Strength

Outcome Measures

Primary Outcomes (18)

• Biochemical sleep marker - Change in salivary melatonin

  Salivary melatonin (pg/mL) will be assessed by enzyme-linked immunosorbent assay (ELISA)

  Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2)

• Biochemical stress marker - Change in salivary cortisol

  Salivary cortisol (ug/dL) will be assessed by ELISA

  Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2)

• Sleep parameter - Change in sleep latency

  Sleep latency (minutes) will be assessed by actigraphy

  Daily throughout the 4 weeks of intervention 1 and 4 weeks of intervention 2

• Sleep parameter - Change in total sleep time

  Total sleep time (hours) will be assessed by actigraphy

  Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2)

• Sleep parameter - Change in sleep efficiency

  Sleep efficiency (percent) will be assessed by actigraphy

  Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2)

• Sleep parameter - Change in sleep quality

  Change in sleep quality (Pittsburgh Sleep Quality Index (PSQI) score) will be assessed by the validated Portuguese version of the PSQI. The PSQI global score, results from the sum of 7 component scores (0-3) and has a possible range of 0-21 points. A global PSQI score ≤ 5 identifies a good sleeper and \>5 a poor sleeper.

  Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2)

• Sleep parameter - Change in mood states

  Change in mood states ('Profile of Mood States' (POMS) score) will be assessed by the validated Portuguese adaptation (Viana, Almeida and Santos, 2001) of a short version of the POMS. A total mood disturbance score is calculated by summing the totals for the 5 negative subscales (tension, depression, fatigue, confusion, anger) and subtracting the positive subscale (vigour), adding 100 to avoid a negative global result. Scores for each item are recorded as 0 for 'not at all' up to 4 for 'extremely'. Total mood disturbance scores can range between -64 and 100. Higher scores indicate a greater degree of mood disturbance.

  Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2)

• Sleep parameter - Change in daytime sleepiness

  Daytime sleepiness (Epworth Sleepiness Scale (ESS) score) will be assessed by the validated Portuguese version (CEISUC, 2001) of the questionnaire. ESS global score results from the sum of 8 item scores (0-3) and can range from 0 to 24 points. The higher the ESS score, the higher that person's average sleep propensity in daily life: 0-5 Lower Normal Daytime Sleepiness; 6-10 Higher Normal Daytime Sleepiness; 11-12 Mild Excessive Daytime Sleepiness; 13-15 Moderate Excessive Daytime Sleepiness; 16-24 Severe Excessive Daytime Sleepiness.

  Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2)

• Sleep parameter - Change in biological rhythms

  Change in biological rhythms ('Morningness-Eveningness Questionnaire' (MEQ) score) will be assessed by the validated Portuguese version (Silvério, Silva and Macedo, 1998) of the MEQ. Four sections of the 16-item scale are assigned a value of 1 through 5, while the remaining twelve questions are assigned a value of 1 through 4. To obtain a global score, the sum of the components is converted to a 5-point scale: definitely morning type (\>59); moderately morning type (54-59); neither type (43-53); moderately evening type (31-42); and definitely evening type (\<31). Morningness-eveningness scores can range between 16-68.

  Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2)

• Metabolic parameter - Change in resting metabolic rate (RMR)

  RMR (kcal) will be assessed by indirect calorimetry

  Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2)

• Dietary intake parameter - Change in total energy intake (TEI)

  TEI (kcal/day) will be assessed by 24h recall and quantified using a dietary analysis software

  Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2)

• Dietary intake parameter - Change in total carbohydrate (CHO) intake

  CHO intake (g/day; percent of TEI) will be assessed by 24h recall and quantified using a dietary analysis software

  Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2)

• Dietary intake parameter - Change in high and low glycemic index CHO

  High and low glycemic index CHO (g/day) will be assessed by 24h recall and quantified using a dietary analysis software

  Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2)

• Dietary intake parameter - Change in triptophan intake

  Triptophan intake (g/day) will be assessed by 24h recall and quantified using a dietary analysis software

  Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2)

• Dietary intake parameter - Change in caffeine intake

  Caffeine intake (mg/day) will be assessed by 24h recall and quantified using a dietary analysis software

  Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2)

• Dietary intake parameter - Change in alcohol intake

  Alcohol intake (g/day) will be assessed by 24h recall and quantified using a dietary analysis software

  Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2)

• Dietary intake parameter - Change in the timing of dietary intake

  Timing of dietary intake (hours) will be assessed for each food and drink mentioned in the 24h recall

  Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2)

• Dietary intake parameter - Change in the frequency of dietary intake

  Frequency of dietary intake (days/week or days/month) will be assessed using a validated food frequency questionnaire

  Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2)

Secondary Outcomes (8)

• Dietary intake parameter - Change in protein intake

  Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2)

• Dietary intake parameter - Change in fat intake

  Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2)

• Body composition parameter - Change in fat free mass (FFM)

  Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2)

• Body composition parameter - Change in fat mass (FM)

  Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2)

• Body composition parameter - Change in visceral adipose tissue (VAT)

  Baseline, week 4 (post-intervention 1) and week 9 (post-intervention 2)

Study Arms (2)

Supplement

EXPERIMENTAL

Melatonin and magnesium-containing pod

Dietary Supplement: Melatonin and magnesium-containing pod

Placebo

PLACEBO COMPARATOR

Placebo pod

Other: Placebo comparator

Interventions

Melatonin and magnesium-containing pod DIETARY_SUPPLEMENT

A 50-100mL hot water drink, obtained from a coffee pod machine, containing 1.9mg of melatonin and 200mg of magnesium in a powdered form, will be ingested 30 minutes before bedtime. Total duration of this intervention: 4 weeks, after which 1 week of washout will occur, before switching to the other intervention.

Supplement

Placebo comparator OTHER

A 50-100mL hot water drink of identical taste, obtained from an identical pod with the same ingredients except melatonin and magnesium, will be ingested 30 minutes before bedtime. Total duration of this intervention: 4 weeks, after which 1 week of washout will occur, before switching to the other intervention.

Placebo

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pittsburgh Sleep Quality Index \>5 as an indicator of sleep disturbance.

You may not qualify if:

• Taking medication which interferes with sleep;
• Shift workers;
• Workers who may experience jet lag (e.g. flight personnel).

Sponsors & Collaborators

• Bettery S.A.: lead

Study Sites (1)

Bettery, S.A.

Porto Salvo, Oeiras, 2740-267, Portugal

RECRUITING

MeSH Terms

Conditions

Sleep Hygiene; Parasomnias

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Filipe Teixeira, PhD

CONTACT

210180425; filipe.teixeira@betterylife.com

Catarina Matias, PhD

CONTACT

catarina.matias@betterylife.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Innovation Manager

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: February 11, 2022
• Study Start: November 28, 2021
• Primary Completion: June 30, 2022
• Study Completion: July 30, 2022
• Last Updated: April 1, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)