Category
»
Primary study
Registry of Trials»ANZCTR
Year
»
2015
INTERVENTION: This intervention is investigating the effect on blood lipids, lipo‐proteins and glycaemic control of adding 30g /day nuts or 30g /day seeds or a combination of nuts and seeds supplying 15g nuts plus 15g seeds to the usual diets of postmenopausal women with type 2 diabetes. This is a randomized parallel study lasting 12 weeks. there are 3 intervention groups.The study will use hazelnuts and sunflower seeds. The nuts and seeds may be consumed at the time best suited to the participant i.e. they have complete choice of time of day or eating occasion with no instructions to eat all at one sitting or as part of a meal. Free choice of time and amount mimics a usual situation and behaviour. The strategies to monitor adherence are supplying nuts and seeds in daily packets of 30g each, with the instruction to return the empty or partially empty packets at the end of each 4 week period when the next set of packaged nuts are collected. The tick sheets are used daily for the participant to record the amount, time, and eating occasion ‐meal or snack. We have used these strategies with success in previous studies and the recording of daily consumption data is useful for per protocol analysis and to assess preferred times and occasions of consumption and the amount consumed at any one time. CONDITION: Dyslipidaemia Glycaemic control Type 2 Diabetes Mellitus PRIMARY OUTCOME: Change in total cholesterol, assessed using a blood sample ; ; Dietary intake assessed by 3 day weighed diet records. Glycosylated haemoglobin (HbA1c) ; HbA1c ; Venous blood for measurement is drawn into a tube with the anticoagulant. ; K2‐EDTA, and measured by enzymatic methods using kits and calibrators ; on a Cobas Mira Plus Analyser. SECONDARY OUTCOME: Plasma Alpha tocopherol Appetite‐rating questionnaire to record hunger, desire to eat, prospective consumption, fullness and preoccupation with thoughts of food measured on 100 mm visual analogue scales (VAS)‐for those in the three intervention groups. The questionnaires have come from the work of Blundell et al. Blundell J1, de Graaf C, Hulshof T, Jebb S, Livingstone B, Lluch A, Mela D, Salah S, Schuring E, van der Knaap H, Westerterp M. ; Appetite control: methodological aspects of the evaluation of foods. ; Obes Rev. 2010 Mar;11(3):251‐70. doi: 10.1111/j.1467‐789X.2010.00714.x. Epub 2010 Jan 29. ; We have used them in a number of previous studies. Change in Apo B100, assessed using a blood sample. This is a primary outcome. Change in ApoA1, assessed using a blood sample. This is a primary outcome. Change in HDL cholesterol, assessed using a blood sample. This is a primary outcome. Change in LDL cholesterol, assessed using a blood sample. This is a primary outcome. Change in triglycerides, assessed using a blood sample. This is a primary outcome. Measurement of physical activity with NL‐1000 Pedometers Rating of acceptance of nuts & seeds. Participants rate “liking” and “desire to consume” the nuts /seeds on 100 mm VAS. Weight measured on calibrated electronic scales waist measurement according to a standard protocol INCLUSION CRITERIA: Type 2 Diabetes Mellitus; post menopausal status; able to comply with the study protocol and to consume nuts and seeds; general good health; no food related allergies.
Epistemonikos ID: 4f1d06fe5bb33546e5eeb51901a5854055381d6e
First added on: Aug 25, 2024