Does the Timing of When High Intensity Intermittent Exercise is Undertaken Matter?

NCT04122209 | Unknown

• 1 other identifier: LRM-11619
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The participants will visit the laboratory on 3 occasions, once for a preliminary visit and a further two occasions to complete experimental trials in a randomised order. The experimental trials will consist of cycling under two conditions; HIIE-First followed by Continuous (Trial-A) or Continuous-First followed by HIIE (Trial-B). Participants will be asked to standardise their diet for 24-hours and complete an overnight fast prior to visiting the laboratory. Participants will then complete 60-min of cycling split throughout the day into two 30-min bouts, HIIE or continuous cycling before breakfast followed by a 3.5 hour rest period before completing their remaining 30-min HIIE or Continuous cycling before lunch. Each experimental trail will last approximately 8 hours and begin at 08:00am. Throughout the trial measurements of subjective feelings of appetite, gastric emptying rate, substrate utilisation and regular blood samples will be taken. Post-trial nutritional and well-being questionnaires will be collected at 24-h post. Study hypothesis

1. 1.The order in which continuous and HIIE is undertaken will result in differences in gastric emptying rate after ingesting a semi-sold lunch?
2. 2.Depending on which mode of exercise is undertaken first will result in different gastrointestinal hormone responses, metabolic responses and appetite responses throughout the trial day?
3. 3.Will the order in which different modes of exercise, undertaken within the same day effect nutritional intake and well-being 24-h after both exercise bout have been completed?
4. 4.Is substrate oxidation effected by the order in which multiple exercise bout of different modes are undertaken within the same day.

Conditions

Weight Loss; Weight Change, Body; Nutritional and Metabolic Disease

Keywords

Nutritional; Metabolic; Endocrine

Outcome Measures

Primary Outcomes (6)

• Change in gastric emptying rate over a 2-hour period

  Gastric emptying rate of a semi-solid meal will be measured using the 13C breath test.

  9 breath samples will be collected at pre-Lunch (315 minutes), 345, 360, 375, 390, 405, 420, 435 and 450 minutes. Which is every 15 minutes for a two-hour period post-lunch.

• Changes in circulating levels of key gut hormones during the trial day

  Hormones will be collected from serum blood samples

  10 samples will be collected at 0 (baseline), 30, 75, 135, 195, 255, 285, 315, 390, 450 minutes (End of trial)

• Changes in circulating levels of key metabolic markers during the trial day

  Serum blood samples will be collected to measure Metabolic markers ( Glucose, triglycerides, Cholesterol and Non-esterified fatty acids)

  10 samples will be collected at 0 (baseline), 30, 75, 135, 195, 255, 285, 315, 390, 450 minutes (End of trial)

• Changes in substrate oxidation during the trial day

  Substrate oxidation will be measured using a breath-by breath gas analyser for a 15-minutes period during each measurement

  8 measurements of substrate oxidation will be taken at 0 (baseline), 30, 135, 195, 255, 285, 390, and 450 minutes (End of trial)

• Changes in appetite using a visual analogue scales (VAS) questionnaire

  Visual analogue scales will be used to measure subjective sensations of appetite. The VAS was composed of 6 questions asking: "how hungry do you feel?" "How full do you feel?" "How much do you think you can eat?" "How satisfied do you feel?" " How nauseous do you feel?" and " How bloated do you feel?". Horizontal lines 100 mm in length were anchored with "I am not hungry at all to I have never been more hungry," "Not at all full to totally full," "nothing at all to a lot," "I am completely empty to I can't eat another bite" " Not at all nauseous to Very nauseous" and " Not at all bloated to Very Bloated" at 0 mm and 100 mm, respectively.

  10 VAS questionnaires will be completed at 0 (baseline), 30, 75, 135, 195, 255, 285, 315, 390, 450 minutes (End of trial)

• Post trial energy intake

  24-hour post trial energy intake using weighed food intake dietary record

  24-hours post-trial total dietary intake

Secondary Outcomes (3)

• Changes in well-being

  6 questionnaires will be completed; pre (0-minutes) and post first exercise bout (30-minutes), and pre (255-minutes) and post second exercise bout (285-minutes). End of the trial day (450-minutes), and 24-hours post-trial

• Changes in perceived exertion

  Perceived exertion will be asked 12 times; 6 during the first 30-minutes exercise period ( 5, 10, 15. 20, 25 and 30-minutes) and a further 6 times during the second exercise period (5, 10, 15, 20, 25 and 30-minutes

• Changes in heart rate during exercise

  Continues exercise ( 5, 10, 15, 20, 25 and 30-minutes ) and Intermittent ( 1, 3, 6, 9, 12, 15, 18, 21, 24 and 27-minutes)

Study Arms (2)

HIIE-First

EXPERIMENTAL

60-min of exercise split into; firstly 30-min HIIE (10 x 1min of PPO, followed by 2-min rest). Secondly 30-min of continuous exercise (50% peak maximal oxygen uptake).

Other: HIIE-First

Continuous-First

EXPERIMENTAL

60-min of exercise split into; firstly 30-min of continuous exercise (50% peak maximal oxygen uptake). Secondly 30-min HIIE (10 x 1min of PPO, followed by 2-min rest)

Other: Continuous-First

Interventions

HIIE-First OTHER

Multiple exercise bout during the same day; HIIE first followed by continuous exercise

HIIE-First

Continuous-First OTHER

Multiple exercise bout during the same day; Continuous exercise first followed by HIIE

Continuous-First

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Male participants will be recruited for this study, as we are unsure if hormonal responses between males and females would influence the outcomes within key measurements. Introducing females within this research area is important. However, for this current study we were particularly interested in data from male participates only
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males
• Age between 18-40 years
• Body mass index = \<29.9 kg/m2
• Non-smokers
• No history of GI symptoms
• Not consuming prescription medication, or no other relevant medical conditions assessed by a medical screening questionnaire.
• Not vegan or lactose intolerant
• Subsequently be physically active, in order to complete the trials.

You may not qualify if:

• Not healthy
• Female
• Under 18 years
• Over 40 years
• Body mass index = \>29.9 kg/m2;
• Smokers
• History of GI symptoms or disease,
• Consuming prescription medication
• Lactose Intolerant
• Vegan
• Subsequently not physically active, in order to complete the trials

Sponsors & Collaborators

• Manchester Metropolitan University: lead

Study Sites (1)

Manchester Metropolitan University

Manchester, M1 5GD, United Kingdom

RECRUITING

Related Publications (3)

• Mattin LR, Yau AMW, McIver V, James LJ, Evans GH. The Effect of Exercise Intensity on Gastric Emptying Rate, Appetite and Gut Derived Hormone Responses after Consuming a Standardised Semi-Solid Meal in Healthy Males. Nutrients. 2018 Jun 19;10(6):787. doi: 10.3390/nu10060787.

  PMID: 29921786 BACKGROUND

• McIver VJ, Mattin LR, Evans GH, Yau AMW. Diurnal influences of fasted and non-fasted brisk walking on gastric emptying rate, metabolic responses, and appetite in healthy males. Appetite. 2019 Dec 1;143:104411. doi: 10.1016/j.appet.2019.104411. Epub 2019 Aug 21.

  PMID: 31445052 BACKGROUND

• McIver VJ, Mattin L, Evans GH, Yau AMW. The effect of brisk walking in the fasted versus fed state on metabolic responses, gastrointestinal function, and appetite in healthy men. Int J Obes (Lond). 2019 Sep;43(9):1691-1700. doi: 10.1038/s41366-018-0215-x. Epub 2018 Sep 24.

  PMID: 30250241 BACKGROUND

MeSH Terms

Conditions

Weight Loss; Body Weight Changes; Metabolic Diseases

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases

Study Officials

• Gethin H Evans, PhD

  Manchester Metropolitan University

  STUDY DIRECTOR

Central Study Contacts

Lewis R Mattin, MRs

CONTACT

01612471215; l.mattin@mmu.ac.uk

Gethin H Evans, PhD

CONTACT

01612471208; gethin.evans@mmu.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Teaching assistant (Nutritional Physiology)

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: October 10, 2019
• Study Start: October 16, 2019
• Primary Completion: May 18, 2020
• Study Completion: August 31, 2020
• Last Updated: October 17, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)