The 2-hour effects of whole-grain wheat in women with overweight or obesity

The effects of whole-grain wheat on postprandial biological markers in Australian women at risk of metabolic dysfunction: a randomised cross-over trial

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000248763

Enrollment

Registered

2013-03-04

Start date

2013-03-08

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

The aim of this study is to measure the acute (2-hour) effects following consumption of wheat whole-grain foods differing in processing treatment on obesity-related measures. This study hypothesises that the grain products that have undergone selected additional processing will contain greater nutrients and bioactive compounds and have favourable outcomes on postprandial measures compared with regular whole-grain products.

Interventions

Following an overnight fast, on two separate occasions separated by a one-week washout, one of two randomised interventions will be served, comprising whole-grain wheat ready-to-eat breakfast cereal prepared by either regular or additional processing methods, with low fat milk, standardised to 50g available carbohydrate (approximately 4 biscuits and 300 ml milk).

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver)

Eligibility

Sex/Gender

All

Age

30 Years to 60 Years

Healthy volunteers

Inclusion criteria

Female Overweight or obesity by waist circumference >80 cm or BMI > 25-35 kg/m2 Age 30-60 years

Exclusion criteria

Participants with an allergy to wheat, gluten, dairy or lactose. Pregnancy or lactation. Smoking. Liver, kidney or heart disease. Type 1 diabetes and type 2 diabetes with insulin medication. The use of any medication for weight loss. Participants that do not regularly consume breakfast. Unable to participate for 4-week period, including preliminary information visit and wash-out period. Excessive exercisers, participating in regular physical activity in excess of moderate intensity and duration. Participants with obesity caused by genetic factors or medication. Neurological, endocrinological or other major systemic disease, including malignancy. Acute illness or current evidence of acute or chronic inflammatory or infective disease; treatment for anaemia within the past 3 months; cirrhosis or chronic hepatitis.

Outcome results