Effects of a high fat, high carbohydrate meal on metabolic endotoxemia and reproductive function in overweight and obese males

• Register: ANZCTR
• Last refreshed on: 22 July 2019
• Main ID: ACTRN12617001034325
• Date of registration: 17/07/2017
• Prospective Registration: Yes
• Primary sponsor: University Of South Australia
• 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.
• Date of first enrolment: 17/07/2017
• Target sample size: 12
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12617001034325.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Non-randomised trial; Assignment: Crossover;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Miss Amy Hill

• Name: Dr Karma Pearce

Key inclusion & exclusion criteria

Inclusion criteria: Males aged between 18-50 with a BMI over 25.
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

Age minimum: 18 Years
Age maximum: 50 Years
Gender: Males

Health Condition(s) or Problem(s) studied

Diet and Nutrition - Obesity

Diet and Nutrition - Other diet and nutrition disorders

Metabolic Endotoxemia;Reproductive Function;Gut permeability;overweight/obesity;
Metabolic Endotoxemia
Reproductive Function
Gut permeability
overweight/obesity

Reproductive Health and Childbirth - Other reproductive health and childbirth disorders

Intervention(s)

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 parti

Primary Outcome(s)

Changes in endotoxin level in blood[Endotoxin was measured at 0,1,2,3,4 hour intervals for all 12 arms]

Reproductive Hormone level changes in serum - testosterone[Testosterone was measured at 0,1,2,3,4 hour intervals for all 12 arms]

Secondary Outcome(s)

Sleep Quality - questionnaire (Pittsburgh Sleep Quality Index)[Sleep quality questionnaires were collected at all 12 visits]

Physical Activity Questionnaire (Baecke Questionnaire)[Physical activity questionnaires were collected at the additional 12 visits.]

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)[Dietary histories were collected at all 12 visits]

Changes in reproductive hormones in serum - estrogen[Estrogen was measured at 0,1,2,3,4 hour intervals for all 12 arms]

Changes in reproductive hormones in serum - follicle stimulating hormone[FSH was measured at 0,1,2,3,4 hour intervals for all 12 arms]

Changes in reproductive hormones in serum - lutenising hormone, [LH was measured at 0,1,2,3,4 hour intervals for all 12 arms]

Changes in reproductive hormones in serum- SHBG[Both visits at time 0,1,2,3,4 hour intervals]

Secondary ID(s)

Nil Known

Source(s) of Monetary Support

University of Australia

Ethics review

Status: Approved
Approval date:
Contact:

University of South Australia's Human Research Ethics Committee

Results

• Results available: Yes
• Date Posted: 09/07/2019
• Date Completed: 15/11/2018