Impact of Single Exercise Session Conducted Prior to PKU Type Meal on Appetite Hormones and Energy Intake

NCT04302285 | Completed

• 1 other identifier: 200170151
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The study applied a randomized, crossover design with preliminary (screening) session and two sequenced experimental trials. Trials were marked as Control trial and Exercise trial. Participants were asked to either resting (Control trial) or exercising (Exercise trial) for one hour. In the two trials, appetite questionnaires were obtained, blood samples were collected, and metabolic rates were measured every 30 minutes. Participants in both trials were presented to a standard isocaloric PKU type meal at 120 min. After the completion of the last measurement, the participants were presented with an ad libitum buffet test meal at 300 min. Participants required to record their EI for the remainder of the experimental day using a self-recorded food diary. Two days prior the experimental trials participants refrained from exercise and alcohol intake. All data collection took place in the metabolic research unit at New Lister Building, Glasgow Royal Infirmary.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Peptide YY (PYY)

  Changes in plasma concentration of fasting and postprandial PYY were measured during the Exercise and Control trials.

  300 minutes through study completion, an average of 12 days

• Glucagon-like peptide-1 (GLP-1)

  Changes in plasma concentration of fasting and postprandial GLP-1 were measured during the Exercise and Control trials.

  300 minutes through study completion, an average of 12 days

Secondary Outcomes (5)

• Subjective appetite score

  300 minutes through study completion, an average of 12 days

• Dietary intake

  24 hours through study completion, an average of 12 days

• Diet induced thermogenesis

  300 minutes through study completion, an average of 12 days

• Growth differentiation factor 15 (GDF-15)

  300 minutes through study completion, an average of 12 days

• Fat oxidation

  300 minutes through study completion, an average of 12 days

Study Arms (2)

Exercise trial

EXPERIMENTAL

In this trial, participants were asked to exercise for one hour under controlled laboratory conditions. Participants were exercising on the treadmill at speed and grade corresponding to 60% of their V̇O2max. Participants were wearing a HR monitor and a face mask while exercising, connected to indirect calorimetry equipment. Appetite questionnaires were obtained, and blood samples were collected at 30, 60, 90 and 120 pre-meal, 150, 180, 210, 240 and 300 min post-meal. Metabolic rate was measured every 30 min after each blood sample. Participants were presented to a standard isocaloric PKU type meal at 120 min. After the completion of the last measurement, the participants were presented with an ad libitum buffet test meal.

Other: PKU type meal and Exercise

Control trial

EXPERIMENTAL

In this trial, participants were asked to rest for one hour. Appetite questionnaires were obtained, and blood samples were collected at 30, 60, 90 and 120 pre-meal, 150, 180, 210, 240 and 300 min post-meal. Metabolic rate was measured every 30 min after each blood sample. Participants were presented to a standard isocaloric PKU type meal at 120 min. After the completion of the last measurement, the participants were presented with an ad libitum buffet test meal.

Other: PKU type meal

Interventions

PKU type meal and Exercise OTHER

* Exercise was conducted prior to PKU type meal. * PKU type meal was based on PKU special low protein foods (50% of total energy intake), natural free protein foods (37%) and protein substitute (13%). Calories provided in breakfast were 600 kcal and were not based on individual dietary requirement. 65% of total energy intake was provided from carbohydrate, 13% from protein and 22% from fat.

Exercise trial

PKU type meal OTHER

PKU type meal was based on PKU special low protein foods (50% of total energy intake), natural free protein foods (37%) and protein substitute (13%). Calories provided in breakfast were 600 kcal and were not based on individual dietary requirement. 65% of total energy intake was provided from carbohydrate, 13% from protein and 22% from fat.

Control trial

Eligibility Criteria

• Age: 22 Years - 35 Years
• Gender Eligibility Details: We decided to study males since in case of females the wash out period of approximately 1 month will be needed to ensure that experimental trials are conducted during the same phase of the menstrual cycle.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy men with
• Body mass index (BMI) ≤29 kg/m2
• Aged 22-35 years
• Stable body weight for one month prior to study enrolment, and were
• Not taking any medication, nutritional supplement or being on a special diet.

You may not qualify if:

• Smokers
• Chronic illness
• Eating disorder
• History of gastrointestinal operations which could interfere with the results of the study

Sponsors & Collaborators

• University of Glasgow: lead

Study Sites (1)

Univesrity of Glasgow

Glasgow, United Kingdom

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal 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

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: March 10, 2020
• Study Start: June 3, 2018
• Primary Completion: June 4, 2019
• Study Completion: July 5, 2019
• Last Updated: March 10, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)