None listed
Conditions
Brief summary
Obesity is a global health epidemic increasing adverse health risks for sufferers. Lifestyle and diet are fundamental to prevention and treatment of obesity-related disorders and attention to the role of staple foods as part of total dietary intake is warranted. Wheat grain is a staple food in Western countries, providing energy, nutrients and fibre, and is commonly consumed as a breakfast cereal. When compared with highly refined cereals, wholegrain cereals are more nutritious beneficial in maintaining healthy weight, blood glucose, cholesterol levels, and reducing cardiovascular and diabetes risks. This study aims to evaluate the effectiveness of consuming 2 types of wholegrain wheat breakfast cereals in overweight and obesity, that have undergone different processing treatments and may differ in chemical composition.
Interventions
We will be testing 2 types of wheat breakfast cereals in short (2 hour) and extended (4 week) interventions by way of a randomised, double blind trial. During each arm, participants will consume an individualised breakfast dose of 1 of the 2 breakfast cereals based on their estimated energy requirements (EER) of no greater than 30% of their total energy requirements. The test cereals are both made from wholegrain wheat, they look and taste similar to common breakfast biscuit cereals, however
We will be testing 2 types of wheat breakfast cereals in short (2 hour) and extended (4 week) interventions by way of a randomised, double blind trial. During each arm, participants will consume an individualised breakfast dose of 1 of the 2 breakfast cereals based on their estimated energy requirements (EER) of no greater than 30% of their total energy requirements. The test cereals are both made from wholegrain wheat, they look and taste similar to common breakfast biscuit cereals, however one of the cereals has undergone an additional processing treatment that may have altered the nutritional composition of the cereal. In Arm 1, participants will be randomised to consume 1 of the test cereals, and arrive fasted for baseline blood collection followed by feeding, blood collection and appetite sensation recording over 2 hours. This is immediately followed by participants consuming the same test cereal daily for 4 weeks whilst otherwise maintaining their usual diet. Participants will visit the clinic weekly for monitoring, anthropometric measurements, and issue of cereal supply. At the end of 4 weeks participants will repeat testing to measure the response of eating the test cereal daily over 4 weeks. After a 2 week wash out period, Arm B commences with the same procedure as Arm A but with the alternate breakfast cereal.
Sponsors
Victoria University
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
30 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Overweight or obesity confirmed by Body Mass Index >25, and waist circumference >80cm (females) and 94cm (males). The BMI used will be adjusted for ethnicity where appropriate. Participants will be otherwise deemed healthy.
Exclusion criteria
Allergy to wheat, gluten, dairy or lactose. Pregnancy or lactation. Smoking. Liver, kidney and heart disease. Type 1 diabetes or type 2 diabetes with insulin medication. Weight loss medication. Participants that do not regularly consume breakfast or could not tolerate the same breakfast for the study period. Unable to participate for the entire study period. Excessive exercisers defined as significant levels of sport or strenuous leisure activity (30-60 minutes 4-5 times/week) or heavy occupational work (eg high performance athletes, farmers, construction workers, miners, forest workers). Obesity caused by genetic factors or medication. Neurological, endocrinological or other major systemic disease, including malignancy. Acute illness or current evidence of acute or chrnoic inflammatory in infective disease. Treatment for anaemia within the past 3 months. Cirrhosis or chronic hepatitis.
Outcome results
None listed