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

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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617001034325
Enrollment
10
Registered
2017-07-17
Start date
2017-07-17
Completion date
2018-08-20
Last updated
2019-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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. Particip

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).

Sponsors

University Of South Australia
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Prevention

Eligibility

Sex/Gender
Male
Age
18 Years to 50 Years
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 20, 2026