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Effects of menstrual cycle on the gastrointestinal function, hormone, appetite and energy intake responses to nutrients

Effects of menstrual cycle on the antropyloroduodenal motility, hormone, appetite and energy intake responses to intraduodenal nutrients in healthy female volunteers

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610000266066
Enrollment
8
Registered
2010-03-31
Start date
2010-08-01
Completion date
2016-06-01
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Each subject will be required to attend the Discipline of Medicine, Royal Adelaide Hospital, on four occasions. They will receive in randomised, double-blind order, infusions of either lipid (Intralipid (Resgistered Trademark) or 0.9% saline. On two occasions, they will receive infusions of saline (control) and on the other two occasions they will receive lipid (once each during the luteal and folicular phases). The primary outcome evaluated will be energy intake assessed using measuring food intake at a buffet meal after the intraduodenal infusion.

Interventions

Subjects will receive an intraduodenal infusion of intralipid (Registered trademark) (10% given at a rate of 2.8kcal/min or 2.545ml/min) or control (0.9% saline given at a rate of 2.545ml/min) for a duration of 90 minutes on each study day. On two occasions, they will receive infusions of control (saline) and on the other two occasions they will receive lipid (intralipid), once each during the luteal phase and follicular phases. Srudy visits will be separated by 3-14days. Energy intake will be a

Subjects will receive an intraduodenal infusion of intralipid (Registered trademark) (10% given at a rate of 2.8kcal/min or 2.545ml/min) or control (0.9% saline given at a rate of 2.545ml/min) for a duration of 90 minutes on each study day. On two occasions, they will receive infusions of control (saline) and on the other two occasions they will receive lipid (intralipid), once each during the luteal phase and follicular phases. Srudy visits will be separated by 3-14days. Energy intake will be assessed using a weighed buffet meal, immediately after infusion (t=90 minutes). The buffet meal consists of: 4 slices of wholemeal bread (sunblest (Registered Trademark)) 4 slices of white bread (sunblest (Registered Trademark)) 100g of deli leg ham (Woolworths) 100g of chicken roll, shaved (Woolworths) 4 Coon Tasty (Registered Trademark) Cheese slices 100g of tomato 100g iceberg lettuce 100g of continental cucumber 600ml of water 300ml of Daily Juice (Registered Trademark) unsweeted orange juice 375m Farmers Union (Registered Trademark) iced coffee 1 medium red delicious apple 1 medium banana 200g of Yogo (Registered Trademark) chocolate custard 150g of Goulburn Valley (Registered Trademark) fruit salad 200g of Yoplait (Registered Trademark) Strawberry yoghurt 25g of Flora (Registered Trademark) margarine 25g of Masterfoods (Registered Trademark) mayonnaise.

Sponsors

A/Prof Christine Feinle-Bisset
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

To be included, subjects must be healthy females volunteers, must not meet any of the exclusion criteria outlined below:

Exclusion criteria

-pregnant or breast feeding -using any contraceptive medication -smokers -suffering any significant illnesses (such as diabetes, epilepsy cardiovascular or other respiratory diseases) -significant gastrointestinal disease -restrained eaters (measured using a the restraint component of the Three-factor eating questionnaire) -have any known food allergies -allergic to anaesthetic, -suffer from premenstrual symptom (assessed using the premenstrual screening tool)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026