An interventional study of Investigational meal 1 - Commercial animal-based protein foods [Siew mai (6 pieces) and Ngoh hiang (2 pieces)] and Investigational meal 2- Commercial animal-based protein foods [Gyoza (11 pieces) and Luncheon meat (5 pieces)] in Nutrition, Healthy, sponsored by Singapore Institute of Food and Biotechnology Innovation. Recruiting at 1 site in Singapore. Open to male participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-20.
Sponsored by Singapore Institute of Food and Biotechnology Innovation · Not applicable, Interventional, and Other
The study aims to investigate the effects of optimized plant protein mixtures versus their animal protein equivalents on satiety, protein metabolism, and overall metabolic health
The research described in this application is crucial as it addresses a fundamental issue - the nutrition quality of plant-based diets. Plant-based diets are widely acknowledged for their health benefits as they are known to reduce disease risks and all-cause mortality. However, concerns about plant protein quality arise due to disparities in amino acid profiles, particularly their essential amino acid adequacy, which remains a challenge in adopting a plant-based protein diet as part of a healthy diet. Other challenges include low palatability, poor texture, flavor, and mouthfeel. To address this, the Singapore Institute of Food and Biotechnology Innovation (SIFBI) has developed Asian-centric plant-based food products by combining multiple plant-protein sources to emulate the amino acid profile of animal proteins. This approach aims to optimize plant-based diets by ensuring enhanced protein quantity and quality in a mixed meal, not only to encourage adaptation of plant based protein into daily meals for environmental sustainability but also with the long-term objectives to use diet as a means to improve metabolic health in the Asian demographics. This human study is designed to explore the effects of consuming optimized plant-protein-based products compared to conventional animal protein- based products on postprandial metabolism and overall metabolic health. The study is structured around several specific objectives:
Singapore Institute of Food and Biotechnology Innovation is the lead sponsor of 69 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Animal-based protein meal; Isoproteic at \~30g of total protein per meal. Siew mai (6 pieces) - steamed Ngoh Hiang (2 pieces) - oven baked
Other: Investigational meal 1 - Commercial animal-based protein foods [Siew mai (6 pieces) and Ngoh hiang (2 pieces)]
Animal-based protein meal; Isoproteic at \~30g of total protein per meal. Gyoza (11 pieces) - steamed Luncheon meat (5 pieces) - oven baked
Other: Investigational meal 2- Commercial animal-based protein foods [Gyoza (11 pieces) and Luncheon meat (5 pieces)]
Plant-based protein meal; Isoproteic at \~30g of total protein per meal. Siew mai (6 pieces) - steamed Ngoh Hiang (1 piece cut into 2) - oven baked
Other: Investigational meal 3- Formulated plant-based protein foods [Siew mai (6 pieces) and Ngoh hiang (1 piece cut into 2)]
Plant-based protein meal; Isoproteic at \~30g of total protein per meal. Gyoza (11 pieces) - steamed Luncheon meat (5 pieces) - oven baked
Other: Investigational meal 4- Formulated plant-based protein foods [Gyoza (11 pieces) and Luncheon meat (5 pieces)]
Participants consume a meal consisting of commercial animal-based protein foods (steamed Siew mai and oven-baked Ngoh hiang) in a fasted state.
Participants consume a meal consisting of commercial animal-based protein foods (steamed Gyoza and oven-baked Luncheon meat) in a fasted state.
Participants consume a meal consisting of formulated plant-based protein foods (steamed Siew mai and oven-baked Ngoh hiang) in a fasted state.
Participants consume a meal consisting of formulated plant-based protein foods (Gyoza and Luncheon meat) in a fasted state.
Free amino acids
Blood samples collected at 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes (plasma and serum)
Time frame: The initial baseline (before investigational meal) at 0 minute, and eight intervals post-meal at 15, 30, 45, 60, 90, 120, 150, and 180 minutes.
Protein utilization
Blood samples collected at 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes (plasma and serum)
Time frame: The initial baseline (before investigational meal) at 0 minute, and eight intervals post-meal at 15, 30, 45, 60, 90, 120, 150, and 180 minutes.
Glucose homeostasis
Blood samples collected at 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes (serum)
Time frame: The initial baseline (before investigational meal) at 0 minute, and eight intervals post-meal at 15, 30, 45, 60, 90, 120, 150, and 180 minutes.
Gut hormones
Blood samples collected at 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes (plasma and serum)
Time frame: The initial baseline (before investigational meal) at 0 minute, and eight intervals post-meal at 15, 30, 45, 60, 90, 120, 150, and 180 minutes.
Markers related to general metabolic health
Blood samples collected at 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes (plasma and serum)
Time frame: The initial baseline (before investigational meal) at 0 minute, and eight intervals post-meal at 15, 30, 45, 60, 90, 120, 150, and 180 minutes.
Untargeted proteomics
To study molecular mechanism underlying the observed outcomes (plasma and serum).
Time frame: The initial baseline (before investigational meal) at 0 minute, and eight intervals post-meal at 15, 30, 45, 60, 90, 120, 150, and 180 minutes.
Visual Analogue Scale Questionnaire
To assess participant's postprandial appetite and satiety, participants complete, C a Visual Analogue Scale (VAS) questionnaire pertaining to their appetite. At baseline time 0 minute, one question will be asked and participants will mark on a scale to indicate how they feel at that moment. A. Questions on appetite and desire for specific food type (how hungry you feel, how satisfied you feel, how full you feel, how much do you think you can eat) Time 15 minute to time 180 minute (8 time points, post meal), following two questions will be asked and participants will mark on a scale to indicate how they feel at that moment. A. Questions on appetite and desire for specific food type (how hungry you feel, how satisfied you feel, how full you feel, how much do you think you can eat) B. Questions on palatability of test meal (to complete immediately after meal intake) (visual appeal, smell, taste, aftertaste, palatibility)
Time frame: The initial baseline (before investigational meal) at 0 minute, and eight intervals post-meal at 15, 30, 45, 60, 90, 120, 150, and 180 minutes.
Gastrointestinal Symptoms Questionnaire
Participants complete a questionnaire pertaining to their gastrointestinal (GI) symptoms before investigational meal (0 minute) and at the end of the session (180 minute). Gastrointestinal symptoms pertaining to flatulence, rumbling, bloating, abdominal pain, abdominal cramps, nausea.
Time frame: The initial baseline (before investigational meal) at 0 minute, and eight intervals post-meal at 15, 30, 45, 60, 90, 120, 150, and 180 minutes.
Plan to share: No
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Singapore Institute of Food and Biotechnology Innovation