Clinical Research Directory

Metabolic Availability of Methionine in Tempeh Chips Among Reproductive-age Women Using Indicator Amino Acid Oxidation (IAAO) Method

The goal of this study is to determine the protein quality of soybean tempeh in the form of chips. The main objective of this study is to determine how much methionine in tempeh can be used by reproductive-age women using the stable isotope method. The tempeh will be studied in the form of chips. This research is being done to bridge the gap between the knowledge of protein requirements and the amount of food needed to meet those requirements. Results from this study will be important to confirm the protein quality of tempeh and thus provide a new alternative good protein source for humans, especially vegetarians and those with low socioeconomic status. Each participant will undergo seven experimental trials randomly. During four experimental trials, methionine intake will be obtained from a crystalline amino acid mixture, and during another three experimental trials, it will be obtained from tempeh chips. Each experimental trial will take three days, consisting of two adaptation days and one study day. During the two adaptation days, four equal meals per day will be consumed by the participants at their own place. On the study day, participants will need to come to the research unit of the National University of Malaysia, Kuala Lumpur campus, to consume nine hourly meals. In addition, during the study day, participants will also need to have their breath samples collected, their expired carbon dioxide rate measured, and consume a stable isotope.

Assessment of Safety, Immunogenicity and Efficacy of R21/Matrix-M1 Malaria Vaccine in Healthy WOCBP in Mali

This will be a double-blind, individually randomised trial, to assess the safety, tolerability, immunogenicity, and protective efficacy of two and three doses of the R21/Matrix-M1 malaria vaccine or placebo given at 4 week intervals in healthy women of childbearing potential (WOCBP), who are on pregnancy prevention during vaccination, but report plans to become pregnant in the near future. Participants will be randomised in Year 1 into three groups in a 1:1:1 ratio: * Arm 1 (n=110): will receive three doses of R21/Matrix-M1 malaria vaccine at months 0, 1 and 2. * Arm 2 (n=110): will receive normal saline (placebo) at month 0 and two doses of R21/Matrix-M1 malaria vaccine at months 1 and 2. * Arm 3 (n=110): will receive three of doses normal saline (placebo) at months 0, 1 and 2. In Year 2: Non-pregnant participants in arms 1 and 2 will be randomised in a 1:1 ratio to receive a booster dose of R21/Matrix-M1 malaria vaccine or placebo at the beginning of the malaria transmission season. Participants in the control group (arm 3) will receive normal saline (placebo). Initial follow-up will be for two years after dose three, with an efficacy analysis at 6, 12, 18 and 24 months after dose 3. Participants will be monitored for safety, tolerability, immunogenicity, and malaria infection during the follow-up period. Participants will also be monitored for pregnancy over 12 months post primary and booster vaccination and those who become pregnant will be followed during their pregnancy and for 1 year post-delivery (as well as their offspring) for safety and malaria infection

Metabolic Availability of Methionine in Mung Beans

The goal of this study is to determine the protein quality of Philippine mung beans. The main objective of this study is to determine the metabolic availability of methionine in mung beans that the body can use. We will test the mung beans by studying them after cooking them as sauté. This research is being done in order to bridge the gap between knowledge of protein requirement and the amount of food needed to meet that requirement. Results from this study will be important for recommendations guiding food choices of mung beans as a major protein source in the diet. Each study participant will be part of seven (7) different experimental diets, and randomly assigned to one of the diets every time. Four (4) reference diets would be based on egg protein composition, and three (3) test diets will have protein from cooked mung beans. Each experimental diet will be studied over 3 days: 2 adaptation days and 1 study day. The meals during the 2-day adaptation period would be consumed at home. On the study day, following a 10 to 12-h overnight fast, the study participants will come to the research unit at the Department of Science - Food and Nutrition Research Institute (DOST-FNRI), Gen. Santos Ave., Bicutan, Taguig City, Philippines, for a period of 8 to 9 hours and consume the diets as 9 hourly meals.