Metabolic effects of kiwifruit in people with prediabetes

Category Primary study
Registry of TrialsANZCTR
Year 2018
INTERVENTION: Intervention: Participants will be assigned randomly to two groups of 20 subjects each. Both the groups will be asked to continue with their customary diet for fifteen weeks (3 weeks lead in, 12 weeks trial period), but not to consume vitamin supplements. During the lead in period of 3 weeks, all the participants will be asked not to consume any kiwifruit to ensure that the 12 weeks kiwifruit intervention period is a discrete kiwifruit consumption period. The control group will then continue to not consume any kiwifruit for twelve weeks but will be asked to drink 250 mL of provided water 30minutes before their breakfast every day. The kiwifruit intervention group will be asked to consume two kiwifruit per day for 12 weeks, PREFERABLY 30 MINUTES BEFORE BREAKFAST. All participants will be asked to attend the Plant & Food Research clinic in the mornings twice, (1) at the beginning of the trial, (2) at the end of the twelve weeks.. The participants will be asked to fast overnight (10‐12 hours) and allow 30 mL of venous blood to be withdrawn from their arm by a trained phlebotomist. Finger prick blood will also be taken for fasting blood glucose measurement. Anthropometric measurement including height, weight, blood pressure (automatic sphygmomanometer), waist and hip circumference will be taken during each visit and questions regarding their general wellbeing will be asked. The participants will therefore be expected to attend the clinic two times during the trial and once for screening before the start of the trial. Participants will also be asked to fill out a seven day food diary two times, covering the seven days leading up to each visit to the clinic. Blood sampling and analytes: On the two visits to the clinic during the intervention period, the participants will be asked to provide fasting venous blood samples which will be taken by a trained phlebotomist. Subjects will be seated and once relaxed and comfortable venous blood will be withdrawn from the anterior cubital fossa into Vacutainer™ tubes. Total blood volume collected at each clinic visit will be 30m. The blood samples will be used to measure the following: 1. HbA1c, insulin, uric acid, creatinine 2. Serum lipids 3. Biomarkers of oxidative stress and inflammation 4. Plasma vitamin C Capillary finger prick blood sample will be taken for fasting blood glucose measurement. SunGold kiwifruit will be supplied by the study team. CONDITION: Diabetes prediabetes PRIMARY OUTCOME: Change in HbA1c level ; Change in HbA1c level in the blood sample. HbA1c between 41‐49 mmol/mol is considered as prediabetic range. Therefore, change in HbA1c value would be monitered SECONDARY OUTCOME: Insulin Plasma lipid profile: HDL cholesterol, LDL cholesterol and total lipids. ; Uric acid biomarkers of inflammation eg, c‐reactive proteins creatinine INCLUSION CRITERIA: All participants have pre‐diabetes and may or may not be taking medication
Epistemonikos ID: a8ac7d19f80d523f27c2b6da77bdb9dbc5b786fc
First added on: Aug 25, 2024