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Trial record 3 of 5 for:    exercise | Phenylketonurias

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

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ClinicalTrials.gov Identifier: NCT04302285
Recruitment Status : Completed
First Posted : March 10, 2020
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
Dr Dalia Malkova, University of Glasgow

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.

Condition or disease Intervention/treatment Phase
Healthy Other: PKU type meal and Exercise Other: PKU type meal Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Impact of Single Exercise Session Conducted Prior to Phenylketonuria (PKU) Type Meal on Appetite Hormones, Metabolic Rate, Fat Oxidation and Energy Intake
Actual Study Start Date : June 3, 2018
Actual Primary Completion Date : June 4, 2019
Actual Study Completion Date : July 5, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arm Intervention/treatment
Experimental: Exercise trial
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
  • 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.

Experimental: Control trial
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
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.




Primary Outcome Measures :
  1. Peptide YY (PYY) [ Time Frame: 300 minutes through study completion, an average of 12 days ]
    Changes in plasma concentration of fasting and postprandial PYY were measured during the Exercise and Control trials.

  2. Glucagon-like peptide-1 (GLP-1) [ Time Frame: 300 minutes through study completion, an average of 12 days ]
    Changes in plasma concentration of fasting and postprandial GLP-1 were measured during the Exercise and Control trials.


Secondary Outcome Measures :
  1. Subjective appetite score [ Time Frame: 300 minutes through study completion, an average of 12 days ]
    Appetite scores during Exercise and Control trials were assessed using a 100-mm Visual Analog Scale, with 0 mm meaning one and 100 mm another extreme of hunger, desire to eat, fullness, prospective food consumption, and satiety.

  2. Dietary intake [ Time Frame: 24 hours through study completion, an average of 12 days ]
    Energy and macronutrient intake during Exercise and Control trials was analysed using WinDiets software based on food composition tables.

  3. Diet induced thermogenesis [ Time Frame: 300 minutes through study completion, an average of 12 days ]
    Metabolic rate measured during Exercise and Control trials by means of indirect calorimetry

  4. Growth differentiation factor 15 (GDF-15) [ Time Frame: 300 minutes through study completion, an average of 12 days ]
    Changes in plasma concentration of fasting and postprandial GDF-15 were measured during the Exercise and Control trials.

  5. Fat oxidation [ Time Frame: 300 minutes through study completion, an average of 12 days ]
    Rate of fat oxidation during Exercise and Control trials was measured by means of indirect calorimetry



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Ages Eligible for Study:   22 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   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.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04302285


Locations
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United Kingdom
Univesrity of Glasgow
Glasgow, United Kingdom
Sponsors and Collaborators
University of Glasgow
Investigators
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Study Chair: Dalia Malkova, PhD University of Glasgow
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Responsible Party: Dr Dalia Malkova, Dr, University of Glasgow
ClinicalTrials.gov Identifier: NCT04302285    
Other Study ID Numbers: 200170151
First Posted: March 10, 2020    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No