Breakfast Intervention Study

To Investigate if sesame seed bars compared to placebo bars can positively impact on risk factors of cardiovascular disease and vitamin E metabolism in subjects with at least one clinical feature of the metabolic syndrome.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000158460

Enrollment

Registered

2007-03-06

Start date

2007-04-09

Completion date

Unknown

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

This study aims to evaluate the effects of two food bar formulations. One of the bars is wheat bran based, and the other sesame seed based. Both formulations are high in fibre and unsaturated fats, which have been shown in previous studies to reduce heart disease risk factors such as blood cholesterol. This study is designed to assess if different dietary sources of fibre and unsaturated fats will have similar or different benefit in reducing heart disease risk factors. The study will be single-blinded with the study co-ordinator blinded to the sequence of treatment the volunteers underwent. However because of a noticeble taste difference between the two bar formulations, the volunteers will be aware of their treatment.

Interventions

This is a randomised, placebo controlled cross-over trial. Volunteers will be randomised with 1 group receiving 25grams of sesame seeds (in a bar format) daily for 5 weeks. The bars will replace the volunteers usual breakfast intake. After a 4 week washout period, the volunteers will receive the alternative bars for another 5 weeks

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

With at least one clinical feature of the metabolic syndrome as defined by the American Heart Association.

Exclusion criteria

1.Use of pure vitamin E supplements. 2.Gastrointestinal disorders. 3.Used antibiotics 4 weeks prior to the study. 4.Alcohol intake >40g/day men 30g/day women. 5.Pre and perimenopausal women. 6.Smoking. 7.Recent coronary/cerebrovascular event <6months. Evidence of renal impairment. 8.Body Mass Index >35. 9.Use of lipid or hypertensive medications. 10. Diabetes requiring insulin. 11. Episodic use of non-steroidal anti-inflammatory medication. 12. History of heart failure

Outcome results