None listed
Conditions
Brief summary
Preliminary studies discovered that supplementation of palm fruit juice (PFJ) manages to improve circulating blood glucose and plasma TG in Nile rats with early diabetes (mean glucose >110 mg/dL). Additionally, a long-term intake of PFJ protected healthy, young Nile rats against diabetes onset, as measured by glucose, blood lipids, and weight of livers and kidneys. These observations are probably due to the antioxidant protection by phenolics compound in the PFJ and their protection of beta-cells in the pancreatic islet against oxidative stress. Therefore, the beta-cells will be able to maintain its integrity and consistently produce insulin. In order to produce continuous and sufficient insulin for the body, the beta-cell must be protected against oxidation stress. Given that the PFJ contains several types of phenolics compounds, we hypothesize that supplementation of the PFJ may provide an antioxidant protection against oxidative stress in diabetic subject. Currently, there is still no clinical data from human study on the physiological effects of PFJ. Moreover, the number of human study investigating the antioxidant potential of several common phenolics compounds such as quercetin and catechin is still limited. One of the goals in delaying the onset of type 2 DM is to preserve the function of beta-cells in the pancreatic islet. Based on the current evidence from the preliminary studies on palm PFJ, we hypothesize that supplementation of PFJ to humans at pre-diabetic state may prevent or delay the development of type 2 DM. However, in order to understand the anti-diabetic effect of PFJ in humans, we need to firstly establish our knowledge on the physiological effects of this compound to normal human subjects. Under physiological condition, PFJ may improve the antioxidant status profiles of healthy subjects. In pre-diabetic subjects, improvement of antioxidant status may have a positive influence on plasma diabetes profiles, since many scientific evidences demonstrate that there is an inverse relationship between antioxidant status and incidence of DM. Therefore, we proposed a human nutrition study to evaluate the antioxidant effects of PFJ (which contained high concentration of palm phenolics compound) on healthy human subjects. Data from this study would hopefully assists us in understanding the therapeutical roles of palm phenolics on humans under normal conditions. This study will involve the recruitment of healthy normal human volunteers. The study will be started with 25 healthy volunteers where they will be supplemented with PFJ or placebo drinks for a period of 60 days. Blood samples will be analyzed for several antioxidant status, lipid and diabetic profiles at baseline and after supplementation (on day-60).
Interventions
Each volunteer will be supplemented with 150 mL of the Palm Fruit Juice or placebo drinks, two times per day (morning and afternoon) for 60 days. A four-weeks of wash-out period is allowed between treatments.
Sponsors
Malaysian Ministry of Agriculture & Agrobased industry
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
20 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy, normal levels of fasting TAG (<1.9 mmol/L) and fasting plasma glucose (<6.1 mmol/L), having good record of compliance. "Having good record of compliance" means that the volunteers must consume the Palm Fruit Juice or placebo treatment everyday. They also need to report to the clinic on day 0, day 30 and day 60 for medical examination and bleeding session.
Exclusion criteria
Smoking, habitual alcohol consumption, taking any types of drugs/pharmacological agent, herbs preparation, pregnant, lactating, on contraseptives, having any cardiovaskular diseases or cancer or any type of pathological conditions.
Outcome results
None listed