The health effects of wheat breakfast cereals in overweight and obesity.

INTERVENTION: 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. CONDITION: Appetite sensations. Biological responses in obesity following wheat breakfast cereals. PRIMARY OUTCOME: Glycemic responses, measured by fasting and postprandial glucose using capillary blood, and insulin from venous blood and indirect measurements (HOMA or QUICKI). Inflammatory response, measured by inflammatory markers associated with increased adiposity (IL‐1B, 1L‐6, TNF‐a, CR‐P and adiponectin), measured from a venous sample and analysed by an appropriate biomarker laboratory assay (eg ELISA or multiplex cytokine detection kit). Postprandial appetite responses over 2‐hours, measured subjectively every 30 minutes by a 100mm Visual Analogue Scale, and biologically by appetite hormones (leptin, ghrelin, GLP‐1) from fasting and postprandial blood samples. 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. SECONDARY OUTCOME: Body Mass Index (BMI) will be calculated by weight (kg)/height (m2). Weight will be measured by digital scale (Tanita InnerScan Body Composition Monitor Model BC‐545) and height measured by stadiometer to the nearest 0.1cm. Body weight (kg) measured in light clothing, no shoes, using a digital scale (Tanita InnerScan Body Composition Monitor Model BC‐545). Daily energy intake, measured by 3‐day food record. Percentage fat and lean mass using body composition scales (Tanita InnerScan Body Composition Monitor Model BC‐545). Resting heart rate, systolic and diastolic blood pressure will be measured taking the mean of three measurements, using an electronic blood pressure machine (Automated digital BP monitor A.N.D, UA‐ 767 Plus, A & D Medica), where the inflatable cuff of the sphygmomanometer is positioned around the upper arm at the level of the heart. Serum antioxidants, will be measured by venous blood sample and subsequent analysis using appropriate laboratory assay. Serum lipids will be measured by venous blood sample and subsequent analysis using appropriate laboratory enzymatic assay. Waist to hip ratio. Waist circumference to be measured using the mean of three measurements taken at the narrowest point between the lower costal (10th rib) border and the iliac crest. Hip measurement taken using a mean of three measurements at the level of the greatest posterior protuberance of the buttocks, whereby the tape is passed around the hips and maintained in the horizontal plane at the designated level.