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Trial registered on ANZCTR


Registration number
ACTRN12617001034325
Ethics application status
Approved
Date submitted
6/07/2017
Date registered
17/07/2017
Date last updated
11/07/2019
Date data sharing statement initially provided
9/07/2019
Date results information initially provided
9/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of a high fat, high carbohydrate meal on metabolic endotoxemia and reproductive function in overweight and obese males
Scientific title
The investigation of the effects of a high fat, high carbohydrate fast food meal on endotoxin levels, reproductive hormones and gut permeability biomarkers in overweight and obese males.
Secondary ID [1] 292349 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic Endotoxemia 303898 0
Reproductive Function 303899 0
Gut permeability 303900 0
overweight/obesity 303988 0
Condition category
Condition code
Diet and Nutrition 303265 303265 0 0
Other diet and nutrition disorders
Reproductive Health and Childbirth 303266 303266 0 0
Other reproductive health and childbirth disorders
Diet and Nutrition 303328 303328 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be required to report to the Sansom Institute Clinical Trial Facility on two occasions with a one week wash out period between the two visits.
First Visit: Participants will be required to fast overnight and will have an intravenous cannula inserted. 10mL of blood will be collected once an hour for 4 hours by a clinician with previous experience with intravenous cannulas. Saliva samples using the passive drool method will also be collected once an hour for the 4 hours. Participants will remain fasted for the duration of the study. Anthropometric measurements including height, waist circumference, weight and body fat will be collected by a clinician using a stadiometer, tape measure and bioelectrical impedance scale. A diet history questionnaire will be undertaken to record one day of dietary history and participants will be asked to record a 3 day diet diary between the two visits to the trial facility. The dietary history will be collected by an experienced nutritionist. Self-answered questionnaires regarding physical activity, sleep and stress will also be completed. At the completion of the first visit, the participants will be provided with lunch.
Second Visit: Participants will arrive fasted again. They will complete the same blood and saliva testing protocol as the first visit with the intervention of a designated fast food meal (2 sausage and egg English muffins and 2 hash browns) consisting of 81g carbs, 51g fat and 32g protein directly after their first blood and saliva sample. The 3 day diet diary will be checked with researchers for completeness on the second visit. The other two questionnaires (sleep and physical activity) will not be reassessed.

For both visits, participants will be supervised by a minimum of 2 researchers to adhere to fasting/consumption guidelines. Participants are required to fast from 10pm the night before, to ensure participants adhere to guidelines - reminder correspondence will be sent out to participants the day prior to the clinic.

10 additional arms were added to the study where participants attended for 10 more intervention occasions approximately 2 weeks apart. Saliva was not collected for any of these arms but all other conditions remained the same for these arms. Diet histories, physical activity and sleep questionnaires were recorded for every intervention arm. The arms included:
1) Intravenous IntralipidTM 20% infusion (25g fat) protocol
One hundred and twenty-five millilitres of IntralipidTM 20% (Baxter; Deerfield, IL) was diluted in 875ml of saline and administered via a peripheral vein in the arm at a rate of 0.1 g fat/minute for the first 15 to 30 minutes of infusion. This was increased to 0.2 g fat/minute in the absence of any adverse reaction.
2) Oral (25g fat) IntralipidTM 20% arm; Two hundred and fifty milliliters of IntralipidTM 20% (Baxter; Deerfield, IL) was consumed orally.
3) Oral (50g fat) IntralipidTM 20% arm; Two hundred and fifty milliliters of IntralipidTM 20% (Baxter; Deerfield, IL) was consumed orally.
4) Orange juice arm; Participants were asked to drink 1L of orange juice (Nudie (nothing but oranges), Australia).
5) Orange juice (76g sugar) + (50g fat) IntralipidTM 20% arm; Participants were asked to drink 1L of orange juice (Nudie (nothing but oranges), Australia) and 250mL of IntralipidTM 20% (Baxter; Deerfield, IL).
6) Olive oil arm; Participants were asked to consume 55g of extra light olive oil (Moro, Australia).
7) Egg white oral arm; participants were asked to consume 41g of protein from egg white dissolved in 500mL water.
8) Whey oral arm; Participants were asked to consume 41g of protein from whey protein isolate dissolved in 500mL water
9) Egg white + 50g fat Intralipid oral arm; Participants were asked to consume 41g of protein from egg white dissolved in 500mL water + (50g fat (supplied as Intralipid TM solution)
10) Egg white & orange juice oral arm; participants were asked to consume 41g of protein from egg white dissolved in 1.25 L orange juice (76g sugar).
Intervention code [1] 298528 0
Other interventions
Comparator / control treatment
Participants will act as their own control. Their results from the baseline visit will act as the control for the intervention diet results from the second visit.
Control group
Active

Outcomes
Primary outcome [1] 302642 0
Changes in endotoxin level in blood
Timepoint [1] 302642 0
Endotoxin was measured at 0,1,2,3,4 hour intervals for all 12 arms
Primary outcome [2] 302643 0
Reproductive Hormone level changes in serum - testosterone
Timepoint [2] 302643 0
Testosterone was measured at 0,1,2,3,4 hour intervals for all 12 arms
Secondary outcome [1] 336627 0
Dietary history in form of 3 day diet diary (2 weekdays and one weekend day - excluding days participant has been to the clinic for the trial)
Timepoint [1] 336627 0
Dietary histories were collected at all 12 visits
Secondary outcome [2] 336628 0
Sleep Quality - questionnaire (Pittsburgh Sleep Quality Index)
Timepoint [2] 336628 0
Sleep quality questionnaires were collected at all 12 visits
Secondary outcome [3] 336813 0
Physical Activity Questionnaire (Baecke Questionnaire)
Timepoint [3] 336813 0
Physical activity questionnaires were collected at the additional 12 visits.
Secondary outcome [4] 336887 0
Changes in reproductive hormones in serum - follicle stimulating hormone
Timepoint [4] 336887 0
FSH was measured at 0,1,2,3,4 hour intervals for all 12 arms
Secondary outcome [5] 336908 0
Changes in reproductive hormones in serum - estrogen
Timepoint [5] 336908 0
Estrogen was measured at 0,1,2,3,4 hour intervals for all 12 arms
Secondary outcome [6] 336909 0
Changes in reproductive hormones in serum- SHBG
Timepoint [6] 336909 0
Both visits at time 0,1,2,3,4 hour intervals
Secondary outcome [7] 336910 0
Changes in reproductive hormones in serum - lutenising hormone,
Timepoint [7] 336910 0
LH was measured at 0,1,2,3,4 hour intervals for all 12 arms

Eligibility
Key inclusion criteria
Males aged between 18-50 with a BMI over 25.
Minimum age
18 Years
Maximum age
50 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
consumption of fish oil or probiotic supplements.
immune suppressant medication
androgen treatments/hormone therapy
inflammatory disease (IBS/IBD, kidney disease, autoimmune disease)
infectious blood diseases
antibiotic use

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/07/2017
Actual
17/07/2017
Date of last participant enrolment
Anticipated
28/07/2017
Actual
20/08/2018
Date of last data collection
Anticipated
4/08/2017
Actual
15/11/2018
Sample size
Target
12
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 296906 0
University
Name [1] 296906 0
University of Australia
Country [1] 296906 0
Australia
Primary sponsor type
University
Name
University Of South Australia
Address
GPO Box 2471
ADELAIDE
5001 SA
Country
Australia
Secondary sponsor category [1] 295908 0
None
Name [1] 295908 0
Address [1] 295908 0
Country [1] 295908 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298116 0
University of South Australia's Human Research Ethics Committee
Ethics committee address [1] 298116 0
University of South Australia Human Research Ethics Committee - online application
University of South Australia
GPO Box 2471
Adelaide SA 5001
Ethics committee country [1] 298116 0
Australia
Date submitted for ethics approval [1] 298116 0
Approval date [1] 298116 0
15/05/2017
Ethics approval number [1] 298116 0

Summary
Brief summary
This is a two arm crossover study investigating the effects of a high fat, high carbohydrate meal on endotoxin levels and its effect on reproductive hormones in overweight and obese males.

The study involves male participants aged between 18-50 with a BMI over 25 engaging in two clinical sessions. The first session requires the participant to be completely fasted. Blood endotoxin, testosterone, inflammatory markers and gut permeability markers are tested over a 5 hour period. Saliva testosterone is also measured over the 5 hours. The second session the participant consumes a designated high fat, high carbohydrate meal immediately to determine whether the meal has an effect on endotoxin in circulation and whether this is reflected in changes in reproductive hormone levels and inflammation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76046 0
Dr Karma Pearce
Address 76046 0
University of South Australia
P1-26
City East Campus
GPO Box 2471
ADELAIDE
5001 SA
Country 76046 0
Australia
Phone 76046 0
+61 8 830 21133
Fax 76046 0
Email 76046 0
Karma.Pearce@unisa.edu.au
Contact person for public queries
Name 76047 0
Miss Amy Hill
Address 76047 0
University of South Australia
City East Campus
GPO Box 2471
ADELAIDE
5001 SA
Country 76047 0
Australia
Phone 76047 0
+61 8 830 21133
Fax 76047 0
Email 76047 0
hilar001@mymail.unisa.edu.au
Contact person for scientific queries
Name 76048 0
Dr Karma Pearce
Address 76048 0
University of South Australia
City East Campus
GPO Box 2471
ADELAIDE
5001 SA
Country 76048 0
Australia
Phone 76048 0
+61 8 830 21133
Fax 76048 0
Email 76048 0
Karma.Pearce@unisa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseMechanistic insights into the aetiology of post-prandial decline in testosterone in reproductive-aged men.2019https://dx.doi.org/10.1111/and.13418
EmbaseThe effect of macronutrients on reproductive hormones in overweight and obese men: A pilot study.2019https://dx.doi.org/10.3390/nu11123059
N.B. These documents automatically identified may not have been verified by the study sponsor.