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Trial details
Impact of Phosphorus Ingestion with Fructose and Glucose on Substrate Utilization in Active Individuals During Moderate Exercise
Current status:
Approved
|
Date registered:
15/10/2020
|
Date last updated:
08/10/2020
Trial version(s)
Current: 07/10/2020
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Main Information
Primary registry identifying number
LBCTR2020104612
Protocol number
BIO-2019-0257
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
Lebanon
Type of registration
Prospective
Date of registration in national regulatory agency
07/10/2020
Primary sponsor
University Research Board (URB), American University of Beirut (AUB)
Primary sponsor: Country of origin
Lebanon
Public title
Impact of Phosphorus Ingestion with Fructose and Glucose on Substrate Utilization in Active Individuals During Moderate Exercise
Acronym
Scientific title
Impact of Phosphorus Ingestion with Fructose and Glucose on Substrate Utilization in Active Individuals During Moderate Exercise
Acronym
Brief summary of the study: English
Carbohydrate loading protocols are common among high-level endurance athletes. When the time of exercise exceeds 60 minutes, simple sugars serve as the best exogenous energy suppliers to the exercising muscles.Timing of ingestion and type of carbohydrates are extremely important in these sports. In this study, we would like to assess energy expenditure and substrate oxidation rates following a fructose-glucose load (with or without phosphorus) after a high carbohydrate meal pre-, during, and post-endurance exercise. This will provide insights on effective sports nutrition interventions to increase exercise performance in major endurance-based sports events.
Brief summary of the study: Arabic
تعتبر بروتوكلات الجرعة العالية من الكربوهيدرات شائعة بين الرياضين شديدي التحمل. عندما تزيد مدة التمرين عن الستين دقيقة فإن السكريات البسيطة تعتبر أفضل مزود للطاقة بالنسبة للعضلات التي يتم تمرينها. يعتبر توقيت تناول الجرعة ونوع الكربوهيدرات المستعملة مهم جداً في نوع الرياضة آنفة الذكر. في هذه الدراسة ، نود تقييم معدل الحرق واكسدة الكربوهيدرات والدهون في الجسم البشري بعد استهلاك جرعة من الفركتوز والجلوكوز (مع أو بدون الفوسفور) و تناول وجبة عالية المحتوى من الكربوهيدرات (قبل ، خلال ، وبعد) الرياضة الخاصة بالاشخاص شديدي التحمل. والذي بدوره سوف يوفر رؤية حول فعالية التغذية في تحسين اداء الرياضيين في الاحداث الرياضية الكبرى التي تحتاج قدرة تحمل عالية.
Health conditions/problem studied: Specify
Subjects are healthy and active. No health conditions being studied. Health problems being prevented are cardiovascular event (risk less than 1 in 12,000). This is ensured after a cardiac assessment and approval by a physician from the American University of Beirut Medical Center (AUBMC).
Interventions: Specify
Four protocols will be tested on subjects after assessing their VO2 peak and FATMAX. 3.25 hours after a high carbohydrate meal, participants will ingest fructose, glucose (with or without phosphorus) load. 45 minutes later, they will be asked to cycle at their FATMAX until exhaustion. Energy expenditure and substrate oxidation values will be analyzed for a potential fructose-glucose effect.
Key inclusion and exclusion criteria: Inclusion criteria
Healthy and Active American University of Beirut (AUB) students, Health Insurance Plan (HIP)-covered, non-obese and between the ages of 18 and 35 years.
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
35
Key inclusion and exclusion criteria: Exclusion criteria
Previous history of any limitation on physical ability, diabetes, cardiovascular disease (assessed by AUBMC physician), taking supplements or medicine that might affect their metabolic rate, pregnant or breastfeeding, claustrophobic, vegan/allergic to eggs or having unstable bodyweight during the past 6 months.
Type of Study
Type
Interventional
Type of intervention
Dietary interventions
Trial scope
Dose-response
Trial scope: Specify scope
Study design: Allocation
Single Arm Study
Study design: Masking
Open (masking not used)
Study design: Control
N/A
Study phase
N/A
Study design: Purpose
Basic science
Study design: Assignment
Single
Pharmaceutical class
No pharmaceutical product
Therapeutic indication
No therapeutic indication
Therapeutic benefit
Study benefits are mainly on energy expenditure, carbohydrate and fat oxidation and exercise performance
Biospecimen retention
None retained
Biospecimen description
Target sample size
20
Actual enrollment target size
Date of first enrollment: Type
Anticipated
Date of first enrollment: Date
01/11/2020
Date of study closure: Type
Anticipated
Date of study closure: Date
28/10/2021
Recruitment status
Pending
Date of completion
IPD sharing statement plan
No
IPD sharing statement description
No IPD sharing statement plan
Additional data URL
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
N/A
N/A
Sources of Monetary or Material Support
Name
University Review Board (URB) at Amercian University of Beirut (AUB)
Secondary Sponsors
Name
N/A
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Elie-Jacques
Fares
Department of Nutrition and Food Sciences, Faculty of Agricultural and Food Sciences, American University of Beirut
Lebanon
+96179195509
ef08@aub.edu.lb
AUB
Scientific
Elie-Jacques
Fares
Department of Nutrition and Food Sciences, Faculty of Agricultural and Food Sciences, American University of Beirut
Lebanon
+96179195509
ef08@aub.edu.lb
AUB
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
American University of Beirut (AUBMC)
Dr. Afif Moufarrij
Emergency Medicine and Primary Care Sports Medicine
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
American University of Beirut Medical Center
24/01/2020
Karine Ismail
irb@aub.edu.lb
Tel:+961-1-738024 or +961-1-350000 ext: 5591
Countries of Recruitment
Name
Lebanon
Health Conditions or Problems Studied
Condition
Code
Keyword
Carcinoma in situ of other specified sites (D09.7)
N/A
Interventions
Intervention
Description
Keyword
High carbohydrate meal and a load of different glucose, fructose and phosphorus doses
Subjects will come to the lab have a high carbohydrate meal (HCM) calculated according to each participant’s body needs: HCM (75% carbohydrates, 15% fat and 10% protein) will be calculated as 30% of each participant’s basal metabolic rate (BMR). The meal will contain toast, butter, jam and a shake (egg white powder, starch and sugar) if needed. 3.25 hours later they will have a sugary drink of different composition each time. 4 Visits will be randomized and subjects will be blinded to the type of sugar/phosphorus they are ingesting: High-glucose/Low-fructose (with/without phosphorus), High-fructose/ Low-glucose (with/without phosphorus), before they exercise at FATMAX intensity until exhaustion.
glucose, fructose, phosphorus, carbohydrates
Primary Outcomes
Name
Time points
Measure
Cardiorespiratory and metabolic responses
Before, during and after exercise
Respiratory quotient (RQ)
Heart rate
Before, during and after exercise
Heart rate (bpm)
Energy expenditure
Before, during and after exercise
Calories by Indirect calorimetry
Fat oxidation grams / calories per minute, percentage energy from fat)
During exercise
FATMAX
Perceived exertion
During exercise
The Borg Scale
Peak oxygen consumption
During exercise
VO2max
Key Secondary Outcomes
Name
Time points
Measure
N/A
N/A
N/A
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Download as PDF
Save a PDF copy of the summary of the trial