1) Participation
1.1. How will the study benefit me?
- You will receive information about your health which includes:
- Blood tests, especially your circulating blood glucose levels. Private tests may cost several hundred dollars.
- Dual energy X-ray absorptiometry (DXA) body composition scan that measures body fat, lean mass, and bone density.
- Magnetic resonance imaging (MRI) scan, for those who choose to have this done. This scan identifies the quantity of fat tucked in organs such as the liver and pancreas.
- We expect that you will lose 5-10 percent of your initial body weight over the first 2 months of the study (weight loss phase).
1.2. Do you collect blood samples?
- Yes, we will collect blood samples. This is done by an experienced Research Nurse at our research unit, following best practice methods and protocols, including adherence to all NZ Ministry of Health guidelines. You may also choose to implement a karakia (prayer) for the blood samples, in which case you will be given sufficient time to do before blood collection.
1.3. How often do I need to visit the Human Nutrition Unit?
- Over the 6 months, we will ask you to come in 7 times to collect your homework and to collect your body measurements. There will also be 9 group diet counselling visits which you can choose to attend in person or virtually.
1.4. Will I be compensated to participate in this study?
- Yes, you will be compensated with vouchers. You will receive a $10 voucher per visit to the Human Nutrition Unit, to cover your travel costs. If you are randomly assigned to have an MRI scan, you will receive an additional $20 voucher for each of your three scans. If you are randomly assigned to participate in IC measurements, you will receive an additional $10 voucher on the 3rd ,4th and 7th visits to the Human Nutrition Unit. Finally, if you are randomly assigned to participate in the repeat OGTT measurement, you will receive an additional $10 voucher on the 4th and 7th visits to the Human Nutrition Unit. In addition, you will also receive all meal replacement products in the low energy Cambridge weight-loss diet free of charge.
1.5. Who should I contact to participate in this study?
- Please email FERDINAND@auckland.ac.nz; phone 09 630 1162; or message us on our HNU Facebook (now called ‘Meta’) page “Human Nutrition Unit – HNU, University of Auckland”.
2) Food and beverages during the study
2.1. Will I lose (or gain) weight during this study?
- We expect that you will lose 5-10 percent of your initial body weight in the first 2 months of the study (weight loss phase). You will also receive extensive dietary and weight loss advice to help prevent weight regain in the following 4 months (weight loss maintenance phase).
2.2. What foods and beverages will you provide during the weight loss phase?
- For the first 2 months (weight loss phase), we will provide you with all the meal replacement products in the low energy Cambridge weight-loss diet free of charge. An example of meal replacement products is soups, shakes, and hot meals.
2.3. Can I choose my own meals?
- For the first 2 months (weight loss phase), you will only be given foods from the meal replacement product range. In the 4 months after the weight loss phase (weight loss maintenance phase), you will be free to make your own meals, while receiving extensive dietary and weight loss advice.
2.4. Do you give us drugs/ pharmacological products to consume during the meals?
- No. This study will only assess the effects of feijoa whole fruit powder on health – no drugs will be administered.
2.5. Can I use my own nutritional supplements or medications during this study?
- Yes. We will collect all the information on any nutritional supplements or medications at your screening visit to ensure you comply with the study criteria. In the subsequent study visits, we will record any changes in nutritional supplements or medications you use.
2.6. Can I eat additional foods if I am hungry?
- During the first 2 months (weight loss phase), you may only consume foods that are prescribed to you. In the 4 months after the weight loss phase (weight loss maintenance phase), you will be free to choose the foods you eat, while receiving extensive dietary and weight loss advice.
2.7. Can I drink my own lemon water, tea, or diet drinks during the weight loss phase?
- No. You may only consume water and drinks you choose from the meal replacement product range.
3) Lifestyle during the study
3.1. Can I still go about my normal daily routine?
- Yes, going about your normal daily routine is advised throughout the 6 months of the study. Over the course of the study, we require you to visit the Human Nutrition Unit on 7 occasions. If you are randomly assigned to do the repeat OGTT + IC, you will be required to stay a few hours extra on visits 4 and 7. If you are randomly assigned to have an MRI scan, you will be required to stay longer on visits 3, 4 and 7.
3.2. Can I exercise during the study?
- Yes, you can still exercise during this study. However, during the mixed meal tests, we ask you to avoid vigorous exercise for the duration of the test (3 days). Vigorous exercise is defined by the Ministry of Health as “you can’t say more than a few words without pausing for breath”. For example, aerobic dancing, power walking, power lifting, or intense cycling are all considered vigorous activity.
3.3. Can I continue to consume nicotine?
- No. Unfortunately we require participants to abstain from nicotine in the lead up and during the study. Even if you are using a nicotine-free vape, you will need to stop vaping at least 2 weeks before the start of the study.
3.4. What if I get an unexpected meeting on my study visit days?
- Please let us know as early as possible and we will accommodate this as best as we can.
4) Study Procedure
4.1. Will there be other participants going through the study programme with me?
- Yes. You will be in a cohort of 40 participants who will all be going through the study at the same time.
4.2. Is there free parking outside the Human Nutrition Unit?
- Yes, you will be provided with free street parking during your visits.