Effect of Nutrient Delivery Pattern on Biological Rhythms in Human Skeletal Muscle

NCT03906409 | Completed

• 1 other identifier: FE
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Recent work has established biological rhythms in human skeletal muscle. It remains unknown how the timing and pattern of meals influences these rhythms. Therefore, this study sets out to establish how frequent (CONSTANT) vs infrequent (BOLUS) feeding patterns influence established biological rhythms in skeletal muscle.

Conditions

Circadian Rhythms; Feeding Patterns

Keywords

Feeding Patterns; Skeletal Muscle; Metabolism; Circadian Rhythms; Diurnal Rhythms

Outcome Measures

Primary Outcomes (2)

• Autophagy

  Rhythms in autophagy with different feeding patterns

  4 hours

• Transcriptomic, rhythms in human skeletal muscle

  Assessing rhythms in core-clock genes within the muscle samples

  Over a 24-hour period at a 4 hour resolution

Secondary Outcomes (2)

• Endocrine responses of systemic blood plasma over 24-hours

  24-hours

• Continuously monitored subcutaneous interstitial glucose concentrations

  48-hours

Study Arms (2)

Constant

ACTIVE COMPARATOR

Participants will be provided with their daily energy requirements in a continuous drip across the day (1 ml/minute).

Other: Constant

Bolus

EXPERIMENTAL

Participants will be provided with their daily energy requirements in two bolus feeds. One at 08:00-08:15 and one at 20:00-20:15

Other: Bolus

Interventions

Constant OTHER

Participants will be provided with their daily energy requirements in a continuous drip across the day (1 ml/minute).

Constant

Bolus OTHER

Participants will be provided with their daily energy requirements in two bolus feeds. One at 08:00-08:15 and one at 20:00-20:15

Bolus

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index \>19 but \<30 kg/m2
• Be able and willing to give informed oral and written consent, complete and meet the defined criteria of pre-study questionnaires and screens,
• Have a regular sleep cycle with a sleep duration between 6 and 8 hours, do not exhibit extreme morning or evening preference (Horne and Ostberg, 1976)
• Agree to keep a constant sleep/wake cycle with a self-selected 8 hour sleep duration (from which it cannot be deviated by more than 30 minutes) for one week prior to the lab study,
• Obtain 15 minutes of sunlight within 1.5 hours of waking up and agree to nap only within a 4 h designated nap window for one week prior to the lab study,
• Allow confirmation of compliance to these instructions by wearing ActiHeart monitors continuously and complete daily sleep and event diaries for one week before the study session,
• Agree to refrain from alcohol, caffeine, heavy exercise and certain food components TWO days before the study session,
• Agree to weigh and record daily meals (based on individual energy requirements) for TWO days prior to the study,
• Agree to refrain from prescribed and 'over the counter' medication and food/vitamin supplements for a wash-out period three weeks before and during the study.

You may not qualify if:

• Are taking regular medication (also non-prescribed) or food supplements (e.g vitamins, minerals, fish oil, antioxidant tablets) from which it is not possible to refrain, known to influence: Sleep/alertness/the circadian timing system (e.g beta-blockers, barbituates, antidepressants, benzodiazepines, melatonin, ritalin, modafinil, soporifics, St John's Wort), any of the metabolic functions (e.g. affecting thyroid, kidney, liver or gastrointestinal function)
• Any of the inflammatory markers (e.g. aspirin, ibuprofen, antiobiotics, hay fever medication, medication for sore throats and colds)
• And/or any of the endothelial markers (e.g. ACE inhibitors and angiotensin (receptor) blockers, diuretics, Beta-blockers, anti-thrombosis medication),
• Have a history of psychiatric or neurological disease or drug and alcohol abuse,
• Have donated over 400 ml of blood in the three months preceding the study,
• Have participated in shift work or have travelled across more than two time zones within three weeks of the study,
• Do not keep a regular sleep-wake cycle,
• Do not refrain from alcohol, caffeine containing drinks (e.g. coffee, coke, tea, redbull), heavy exercise and certain foods (e.g. those high in fat and green vegetables) TWO days before and during the laboratory session,
• Normally consume more than 4 cups of caffeinated beverages (e.g. tea, coffee, cola) daily
• Smokers

Sponsors & Collaborators

• University of Bath: lead
• Société des Produits Nestlé (SPN): collaborator

Study Sites (1)

University of Bath

Bath, Somerset, BA2 7AY, United Kingdom

Location

Related Publications (2)

• Christou S, Wehrens SMT, Isherwood C, Moller-Levet CS, Wu H, Revell VL, Bucca G, Skene DJ, Laing EE, Archer SN, Johnston JD. Circadian regulation in human white adipose tissue revealed by transcriptome and metabolic network analysis. Sci Rep. 2019 Feb 25;9(1):2641. doi: 10.1038/s41598-019-39668-3.

  PMID: 30804433 BACKGROUND

• Perrin L, Loizides-Mangold U, Chanon S, Gobet C, Hulo N, Isenegger L, Weger BD, Migliavacca E, Charpagne A, Betts JA, Walhin JP, Templeman I, Stokes K, Thompson D, Tsintzas K, Robert M, Howald C, Riezman H, Feige JN, Karagounis LG, Johnston JD, Dermitzakis ET, Gachon F, Lefai E, Dibner C. Transcriptomic analyses reveal rhythmic and CLOCK-driven pathways in human skeletal muscle. Elife. 2018 Apr 16;7:e34114. doi: 10.7554/eLife.34114.

  PMID: 29658882 BACKGROUND

MeSH Terms

Conditions

Feeding Behavior

Interventions

NOP-bolus regimen

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Study Officials

• Harry A Smith, MSci

  University of Bath

  PRINCIPAL INVESTIGATOR

• James A Betts, PhD

  University of Bath

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor James Betts

Model Details: Participants will be randomised to one of two parallel trial arms: constant feed or bolus feed

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: April 8, 2019
• Study Start: February 28, 2019
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: April 14, 2023

Record last verified: 2023-04

Locations

GB (1)