NCT04249609

Brief Summary

This will be a randomised cross-over study where participants will be asked to undergo screening session followed by submaximal exercise test and then undergo 2 experimental trials, one high CHO trial and another high fat trial, each lasting over 2 days. On Day 1 participants will consume either high CHO or high fat evening meal and on Day 2 they will be exercising for 60 minutes in the fasted state and then consume either high CHO or high fat morning meal and then 5 hours after morning meal ad libitum buffet meal. After this, they will leave metabolic investigation room and will record all food and drinks consumed during the rest of the day. The washout period between the trials will be at least 7 days. Prior to each of the experimental trials, participants will be asked to avoid consumption of coffee and alcohol for the duration of 2 days. All data collection will all take place in the metabolic research unit at New Lister Building (NLB), Glasgow Royal infirmary (GRI).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 23, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 31, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2022

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

3.1 years

First QC Date

November 1, 2019

Last Update Submit

July 30, 2023

Conditions

Keywords

ExerciseAppetiteGastrointestinal hormonesMacronutrientFat oxidationThermic effect of foodEnergy intake

Outcome Measures

Primary Outcomes (3)

  • Appetite Hormones: Glucagon like peptide (GLP-1)

    Plasma concentration during HCHO and LCHO trials

    420 minutes through study completion, an average of 10 days

  • Appetite Hormone: Peptide YY (PYY)

    Plasma concentration during HCHO and LCHO trials

    420 minutes through study completion, an average of 10 days

  • Growth Differentiation Factor-15 (GDF 15)

    Plasma concentration during HCHO and LCHO trials

    420 minutes through study completion, an average of 10 days

Secondary Outcomes (7)

  • Insulin

    420 minutes through study completion, an average of 10 days

  • Glucose

    420 minutes through study completion, an average of 10 days

  • Triglycerides

    420 minutes through study completion, an average of 10 days

  • Subjective appetite scores

    420 minutes through study completion, an average of 10 days

  • Diet induced thermogenesis

    420 minutes through study completion, an average of 10 days

  • +2 more secondary outcomes

Study Arms (2)

High Carbohydrate Meals Around Exercise

EXPERIMENTAL

On day 1, high CHO dinner meal will provide 35% of participants total daily energy requirements. Meal will consist of pasta, meat ball and orange juice. On the day 2, participants will exercise for 60 minutes and then in 60 minutes will consume morning meal, providing 30% of their total daily energy requirements. Morning meal will consist of oats, skimmed-milk, banana and seedless raisins.

Other: HCHO meals and exercise

Low Carbohydrate Meals Around Exercise

EXPERIMENTAL

On day 1, low CHO dinner meal will provide 35% of participants total daily energy requirements. Meal will based on burger, cheese, mushroom, nuts, and butter.On the day 2, participants will exercise fro 60 minutes and then in 60 will consume morning meal, providing 30% of their total daily energy requirements. Meal will consist of white bread, egg, cheese, olive oil, nuts, and olives.

Other: LCHO meals and exercise

Interventions

Exercise will be conducted after high carbohydrate dinner and prior to high carbohydrate breakfast

Also known as: High carbohydrate meals and exercise
High Carbohydrate Meals Around Exercise

Exercise will be conducted after high fat dinner and prior to high fat breakfast

Also known as: Low Carbohydrate and exercise Intervention
Low Carbohydrate Meals Around Exercise

Eligibility Criteria

Age25 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy sedentary males aged between 25-35 years with body mass index (BMI) 25- 30 kg/m2
  • participants with stable body weight for at least 3 months.

You may not qualify if:

  • Smokers, suffering from food allergy, on any dietary supplements or dietary regimes at the time of the study
  • Participants with systolic/diastolic \<90/60 mmHg and \>140/90 mmHg or with history of chronic illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Nutrition, College of Medicine, Veterinary and Life Science

Glasgow, G31 2ER, United Kingdom

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Dalia Malkova, PhD

    University of Glasgow

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Dalia Malkova Senior Lecture in Human Nutrition, School of Medicine, Dentistry & Nursing

Study Record Dates

First Submitted

November 1, 2019

First Posted

January 31, 2020

Study Start

April 23, 2019

Primary Completion

June 2, 2022

Study Completion

August 5, 2022

Last Updated

August 1, 2023

Record last verified: 2023-07

Locations