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Trial registered on ANZCTR


Registration number
ACTRN12622000907741
Ethics application status
Approved
Date submitted
11/04/2022
Date registered
27/06/2022
Date last updated
27/06/2022
Date data sharing statement initially provided
27/06/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of lactose vs sucrose after exercise on postprandial blood glucose control.
Scientific title
Comparing the effect of lactose or sucrose carbohydrate energy replacement following high-intensity interval training on subsequent postprandial glycaemic control in sedentary adults
Secondary ID [1] 306547 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sedentary behaviour (elevated CVD risk and reduced longevity) 326210 0
Condition category
Condition code
Diet and Nutrition 322819 322819 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 323423 323423 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Design. The design will be a double-blind, block randomized (Williams design), cross over design (lactose, sucrose, placebo) conducted over 3 months per participant, comprising of 3 trials and 10 visits to the laboratory. This consists of three 2-day trials per participant, 1 day baseline testing one week prior to experimental trials and insertion of continuous glucose monitor the day before each trial begins.

Visit 1, 1. Study introduction, discussion, questions, consent. Laboratory and cycle ergometer familiarization with a short 3-5 min low intensity ride after bike fit.
Visit 2, will consist of body composition measurements in order to determine body mass and body fat percentage as well as, VO2max/Wmax test and familiarization trial of the performance test. During all exercise sessions, participants will breathe through an on-line gas analysis facemask that covers the mouth and nose, and is attached to a 0.2 micro filter system, which filters microorganisms. At other times, participants will need to comply with the University's health recommendations regarding the global pandemic at the time.
Visit 3, will be conducted at the laboratory either around 24 hours before experimental trial at 16:00 to 17:00h. At this time, a continuous glucose monitor (CGM) (Medtronics Guardian Connect) will be inserted into the subcutaneous tissue on back of the upper arm or if more suitable, on the outer upper thigh. Participants will remain in the lab for ~2-h while a calibration routine involving finger-prick blood samples is conducted (3 samples, time 0, 30 min, 2 h after placement). Participants in the meantime will be instructed on the calibration and data recording procedures using the Ipad or Android App, and also be instructing on the feeding protocol for the standardized diet that will be provided to participants to consume over the following 2-day metabolic trial.
Visit 4, Day 1 of the metabolic trial. This day follows Visit 3. In the morning prior to breakfast, participants will conduct a calibration procedure of the CGM under video instruction from the researchers (Zoom, Teams, Skype). Participants will be free living and consume a standardized mixed-macronutrient meal at standarised times; 9:00 h (breakfast), 12:00 h (lunch) and 15:00 h (snack); depending on personal schedule, the meal and exercise times on both Day 1 and Day 2 may be moved back or forward 1 h. Participants will report to the laboratory at 17:00h with exercise-suitable clothing. After changing the CGM will be recalibrated. Next, they will perform a supervised session of high intensity interval exercise (10x1-min cycle intervals at 80% maximal power, with 1 min recovery at 30% maximal power, total 20 min). Post-exercise (5 min), the test drink or placebo will be ingested. The lactose and sucrose will be consumed from an artificially-flavored 500-ml beverage (lemonade flavour) at a quantity equivalent to the exercise-induced energy expenditure (aerobic metabolism) determined from a regression equation of oxygen consumption to bike power output established during the VO2max test on Visit 2. The control (no sugar) condition will comprise a taste-matched non-caloric placebo beverage, with the exercise calories added as fat to the evening meal (see LCHF). After exercise and drink ingestion, participants will shower (if desired) and rest seated in the laboratory prior to consuming a low-carbohydrate high-fat (LCHF) dinner meal at 19:00h (or + 2 h post exercise). Participants will then leave the laboratory, under instructions to abstain from consuming any food or drink other than water for the rest of the evening.
Visit 5. On Day 2 of the metabolic trial, the participants will report to the lab at 06:30h. The CGM will be recalibrated. A venous catheter will be placed into an antecubital vein by a trained person (David Rowlands, Claire Badenhorst, or certified person) for fasting and postprandial blood collection. A high glucose drink containing 75g will be ingested at 07:00h for assessment of Oral Glucose Tolerance response. Blood samples will be collected at time=0, 30, 60, 120 min. The catheter will be maintained patent with saline flush and removed after the 120 min sample. Participants will have consented to the blood collection and have the option to have remaining blood sample returned if requested. The remaining meals will be mixed macronutrient meals following the same macronutrient split as day 1. The standardized meals at the given times; 10:00hr, 13:00hr and 18:00hr. Some of the study meals will contain animal products (meat, dairy) are not suitable if for participants following a vegetarian or vegan diet.
Blood glucose will be monitored via GCM to the end of Day 2 with special note to post-prandial responses to all meals throughout Day 2.
Visit 6. On an agreed day following Visit 5, the researchers will collect or participants will return the transmitter devices to the lab for cleaning and reuse.
Protocols. Exercise tests will be conducted using the electronically braked cycle ergometers (VeloTron, Racer Mate, Seattle, WA) and gas analysis using a calibrated Moxus MaxII Metabolic System (AEI Technologies, Naperville, IL).
Exercise Protocol. A 5 minute warm-up at 50 W will be completed before the participants complete 10x1-min sprint intervals at ~80% Wmax spaced between 1-min recovery intervals which will involve slow riding at 50W. The exercise will finished with a 5 minute cool down at 50 W. The rating of perceived exertion (RPE) will be recorded after each 1 minute interval using the Borg Scale of RPE.
Carbohydrate drinks. The drinks will comprise lactose or sucrose (Brewshop, Countdown) added to half-diluted (water) artificially-sweetened and flavoured diet drink. The placebo will be the artificially-sweetened and flavoured diet drink without any sugars added. The energy of the carbohydrate beverages will match the exercise-induced energy expenditure measured from the VO2-power regression established during the VO2max test.
Standardised Diet. Each participant will receive the same food, the quantity will be relative to resting energy expenditure (REE). To individualise diets to each participant, daily energy intake is calculated by the Cunningham equation will be used, with energy from basal physical activity accounted for with 1.4*RRE. On day 1, 90% of daily energy was provided at main meals: 30% at each breakfast, lunch, and dinner and 10% of daily energy was a mid-afternoon snack. The macronutrient composition of the breakfast, lunch and snack meals will be followed; ~55% carbohydrate, ~30% fat and ~15% protein. All meals provided will be pre-packaged (e.g., yoghurt, muesli bars, pre-made meals etc) items purchased from local supermarkets.
The day 1 dinner will be consumed at plus 2 h after exercise (e.g., 19:00h) in the lab and is LCHF dinner, which consists of tuna, steamed veges, butter, almonds (~5/80/15% carbohydrate/fat/protein). All subsequent meals will be consumed under free-living conditions and will be pre-packaged mixed-macronutrient meals following the same macronutrient slit as day 1. Breakfast at 7:00h, which will be a high glucose meal consisting of 75g of glucose in water. Participants will be asked to record the actual exact start time and food they ate/drank under free living conditions through diet recall sheets provided. Water and other non-caloric beverages will be allowed within a prescribed maximum quantity of caffeinated beverages of 3 per test day.

Continuous Glucose Monitoring. To measure blood glucose levels, CGM will be used throughout each of the 2-day trials. GCM is a tool to identify glycaemic response to food and exercise outside of the laboratory setting. The sensors (Medtronics Guardian Connect) record interstitial blood glucose concentration and will be inserted into the upper arm about 12 h prior to the first meal of the trial to be consumed on Day 1. Blood glucose information recorded on the sensor will be read through a transmitter and recorded through the specific software downloaded on participant’s iphone/ipad/Android device; if a participant does not have a compatible device, the researchers will provide an ipad. Catheter inserted for calibration of CGM

Intervention code [1] 322972 0
Lifestyle
Intervention code [2] 322973 0
Behaviour
Comparator / control treatment
The control (no sugar) condition will comprise a taste-matched non-caloric placebo beverage, sugar free lemonade, with the exercise calories added as fat to the evening meal (see LCHF).
Control group
Placebo

Outcomes
Primary outcome [1] 330607 0
The primary outcome of the study is to identify the extent to which replenishing the exercise-induced energy deficit with carbohydrate alters subsequent glycemic control using CGM.
Timepoint [1] 330607 0
Per testing block:
Day 1:
-Post-exercise glycaemic excursion (CGM) following the post-exercise test drinks (1 hourly area under curve for up to 3 hours)

Day 2:
-Overall glycaemic response (CGM) 07:00 to 24:00.
-Overnight glycaemia 22:00-06:00
-in response to 75 g glucose ingestion (07:00):
-CGM response (3h) to the OGTT (2 h) and to each controlled meal at 10:00, 15:00, 19:00.
Secondary outcome [1] 406926 0
On Day 2, blood glucose control in response to oral glucose tolerance test (OGTT) in response to prior post-exercise lactose or sucrose ingestion. During the OGTT, venous blood will be collected for measurement of glucose.
Timepoint [1] 406926 0
The OGTT will start at 7:00h and blood will be collected at time zero after cannulae placement, and again at 30, 60, 90, 120 min.
Secondary outcome [2] 409039 0
Day 2. Morning fasting blood triglycerides.
Timepoint [2] 409039 0
Blood will be collected shortly after placement of the cannulae on each test day.
Secondary outcome [3] 411162 0
Day 2. Morning fasting blood free fatty acids.
Timepoint [3] 411162 0
Blood will be collected shortly after placement of the cannulae on each test day.
Secondary outcome [4] 411163 0
Day 2. Morning fasting blood glucose.
Timepoint [4] 411163 0
Blood will be collected shortly after placement of the cannulae on each test day.
Secondary outcome [5] 411164 0
Day 2. Morning fasting blood insulin.
Timepoint [5] 411164 0
Blood will be collected shortly after placement of the cannulae on each test day.

Eligibility
Key inclusion criteria
Sedentary ( in recent months, 150 min or less of purposeful exercise per week), lactose tolerant males and females aged 20-70 years.
Participants will be required to pass the Health Screen Questionnaire.
Minimum age
20 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals will be excluded if they have known glucose, heart and respiratory conditions such as; type I and II diabetes mellitus, atrial fibrillation, congenital heart disease, coronary artery disease, chronic obstructive pulmonary disorder, asthma, cystic fibrosis etc. Some of the study meals will contain animal products (meat, dairy) are not suitable if participants are following a vegetarian or vegan diet, so these diet patterns will be excluded.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed to the person doing the recruitment and screening by way of a third party independent of the research data collection and analysis, who will hold the randomization code and prepare the test drinks.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table using Williams Design/Latin Square for 3 conditions (2x6 sequence allocation). Sequence will be randomly allocated to participant via draw from hat approach.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
The design will be a double-blind, block randomized (Williams design), cross over design (lactose, sucrose, placebo) conducted over 3 months per participant, comprising of 3 trials and 10 visits to the laboratory. This consists of three 2-day trials per participant, 1 day baseline testing one week prior to experimental trials and insertion of continuous glucose monitor the day before each trial begins.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Treatment effects on outcomes will be estimated with linear mixed models in SAS. All data except psychometric will be log-transformed prior to analysis to manage heteroscadiscity and to express outcomes as percents. Fixed effects will be treatment, period and sequence accounting for familiarization, adaptation, or fatigue effects between consecutive trials and the order of exposure. Continuous time-series variables will be baseline adjusted as a numeric covariate. Post-hoc regression analysis may be considered to describe associations between moderating variables and outcomes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
30/05/2022
Date of last participant enrolment
Anticipated
4/07/2022
Actual
Date of last data collection
Anticipated
10/10/2022
Actual
Sample size
Target
12
Accrual to date
4
Final
Recruitment outside Australia
Country [1] 24623 0
New Zealand
State/province [1] 24623 0
Auckland

Funding & Sponsors
Funding source category [1] 310882 0
University
Name [1] 310882 0
Massey University Research Fund
Country [1] 310882 0
New Zealand
Primary sponsor type
University
Name
School of Sport, Exercise, and Nutrition, Massey University
Address
Massey University East Precinct Albany Expressway, SH17
Auckland 0632
Country
New Zealand
Secondary sponsor category [1] 312750 0
None
Name [1] 312750 0
Address [1] 312750 0
Country [1] 312750 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310442 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 310442 0
Ethics committee country [1] 310442 0
New Zealand
Date submitted for ethics approval [1] 310442 0
09/04/2022
Approval date [1] 310442 0
07/06/2022
Ethics approval number [1] 310442 0
12240

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117682 0
Prof David Rowlands
Address 117682 0
School of Sport, Exercise and Nutrition
Massey University East Precinct Albany Expressway, SH17
Albany, Auckland 0632
Country 117682 0
New Zealand
Phone 117682 0
+64 9 2136616
Fax 117682 0
-
Email 117682 0
[email protected]
Contact person for public queries
Name 117683 0
David Rowlands
Address 117683 0
School of Sport, Exercise and Nutrition
Massey University East Precinct Albany Expressway, SH17
Albany, Auckland 0632
Country 117683 0
New Zealand
Phone 117683 0
+64 9 2136616
Fax 117683 0
-
Email 117683 0
[email protected]
Contact person for scientific queries
Name 117684 0
David Rowlands
Address 117684 0
School of Sport, Exercise and Nutrition
Massey University East Precinct Albany Expressway, SH17
Albany, Auckland 0632
Country 117684 0
New Zealand
Phone 117684 0
+64 9 2136616
Fax 117684 0
-
Email 117684 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Study data will be collected in non-identifiable form. Screening information and consent forms will have identifiable data. Only Miss Rose Stirling, Dr David Rowlands, Dr Claire Badenhorst will have access to identifiable data. No IPD will be shared due to participant privacy and confidentiality purposes.



What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.