None listed
Conditions
Brief summary
The question we are investigating is whether adding 30g/d nuts, 30g/d seeds or a combination of both, rich in healthy monounsaturated and polyunsaturated fats, will result in beneficial changes in blood lipid and lipoprotein risk factors related to CVD and whether there will also be an improvement in glycaemic control. This is a study in the community- where women, in the post menopause, with type 2 diabetes will incorporate the nuts and seeds into their usual diets, as part of a meal or as a snack. The participants may also decide whether to consume the daily amount at one eating occasion or divide them during the day, as long as the daily portion is consumed within 24 hours. Consummation times will be at the participants discretion they can decide to consume the nuts and seeds with a meal, as a snack, or divided between between both. Participants will also record on ‘tick sheets’ the time the nuts / seeds were consumed and if alone or with other foods. Tick sheets have been used with success in many previous study. The sheets are supplied with a table for each day where the participants can record the time of day and how the snack was consumed, there will also be a space for comments. The sheets will be returned with the nut or seeds bags when the next 4 weeks allocation is collected. Thus we are also investigating the acceptance of eating nuts regularly and whether this intervention is effective regardless of the background diet, and time of consumption. There will be a control group who will continue with their usual diets. This is to ascertain whether the changes seen are as a result of the intervention and would not just have happened anyway, during the period of the study.
Interventions
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 h
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.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
35 Years to No maximum
Healthy volunteers
No
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.
Exclusion criteria
Neither Type 2 Diabetes Mellitus, post menopausal status nor able to comply with the study protocol. Food related allergies especially to nuts.
Outcome results
None listed