Seaweed meal protein bioavailability and acceptability in adults

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2024
INTERVENTION: The intervention is a seaweed meal (SWM; 400 g), prepared from minimally processed seaweed to improve protein accessibility and optimise mineral content. The SWM is formulated as a dumpling meal containing 152 g dry weight of seaweed which provides approximately 3.1g protein from seaweed plus 8.4 g of protein from other non‐seaweed ingredients. The non‐seaweed ingredients are" potato starch, tapioca starch, soy, egg yolk, shiitake, soy sauce, wongbok cabbage, chikiang vinegar, spring onion, garlic, Panko (bread crumbs), shallots, spices, herbs, chili flakes, coriander, spring onion, salt, ginger. Participants will consume the meal under clinical monitoring on a single morning at the clinic within 10 minutes. After a wash‐out phase of minimum 3 days, the participants will cross over and receive the other treatment. CONDITION: Diet and Nutrition ‐ Other diet and nutrition disorders Postprandial protein appearance in circulation;Micronutrient bioavailability;Seaweed digestion; ; Postprandial protein appearance in circulation ; Micronutrient bioavailability ; Seaweed digestion PRIMARY OUTCOME: The difference in plasma essential amino acid peak concentration (Cmax) between SWM and CON following acute ingestion in adults.[A primary outcome of peak pooled essential amino acid concentration (Cmax) will be assessed (composite outcome), by ultra‐high performance liquid chromatography (UHPLC). Before the intervention begins (at 0 min), and at 30, 60, 90, 120, 180, and 240 min post‐ingestion at each visit.] SECONDARY OUTCOME: The difference in Ca (calcium) in plasma/serum between SWM and CON.[Plasma concentration of Ca (calcium) will be measured using colorimetric assays or inductively coupled plasma mass spectrometry (ICP‐ MS) as appropriate. Before the intervention begins (at 0 min), and at 60, 120, 180, and 240 min post‐ingestion at each visit.] The difference in Fe (iron) in plasma/serum between SWM and CON.[Plasma concentration of Fe (iron) will be measured using colorimetric assays or inductively coupled plasma mass spectrometry (ICP‐ MS) as appropriate. Before the intervention begins (at 0 min), and at 60, 120, 180, and 240 min post‐ingestion at each visit.] The difference in glucose responses between SWM and CON.[Plasma concentration of glucose as measured by electro chemiluminescent and colorimetric assays. Before the intervention begins (at 0 min), and at 30, 60, 90, 120, 180, and 240 min post‐ingestion at each visit.] The difference in heavy metal Cd in urine between SWM and CON.[The analysis of heavy metal Cd will be performed using untargeted mass spectrometry methods including Inductively Coupled Plasma Mass Spectrometry (ICP‐MS) or liquid chromatography‐high resolution mass spectrometry (LC‐MS). Before the intervention begins (at 0 min), and post‐ingestion up to 2 hours (0‐120 min), between 2 to 4 hours (120‐240 min) at each visit. A 24‐hour urine sample (collected between 240 min and 24 hours the following day) will be collected at each visit.] The difference in heavy metal Hg in urine between SWM and CON.[The analysis of heavy metal Hg will be performed using untargeted mass spectrometry methods including Inductively Coupled Plasma Mass Spectrometry (ICP‐MS) or liquid chromatography‐high resolution mass spectrometry (LC‐MS). Before the intervention begins (at 0 min), and post‐ingestion up to 2 hours (0‐120 min), between 2 to 4 hours (120‐240 min) at each visit. A 24‐hour urine sample (collected between 240 min and 24 hours the following day) will be collected at each visit.] The difference in heavy metal iAs in urine between SWM and CON.[The analysis of heavy metal iAs will be performed using untargeted mass spectrometry methods including Inductively Coupled Plasma Mass Spectrometry (ICP‐MS) or liquid chromatography‐high resolution mass spectrometry (LC‐MS). Before the intervention begins (at 0 min), and post‐ingestion up to 2 hours (0‐120 min), between 2 to 4 hours (120‐240 min) at each visit. A 24‐hour urine sample (collected between 240 min and 24 hours the following day) will be collected at each visit.] The difference in heavy metal Pb in urine between SWM and CON.[The analysis of heavy metal Pb will be performed using untargeted mass spectrometry methods including Inductively Coupled Plasma Mass Spectrometry (ICP‐MS) or liquid chromatography‐high resolution mass spectrometry (LC‐MS). Before the intervention begins (at 0 min), and post‐ingestion up to 2 hours (0‐120 min), between 2 to 4 hours (120‐240 min) at each visit. A 24‐hour urine sample (collected between 240 min and 24 hours the following day) will be collected at each visit.] The difference in heavy metal total As in urine between SWM and CON.[The analysis of heavy metal total As will be performed using untargeted mass spectrometry methods including Inductively Coupled Plasma Mass Spectrometry (ICP‐MS) or liquid chromatography‐high resolution mass spectrometry (LC‐MS). Before the intervention begins (at 0 min), and post‐ingestion up to 2 hours (0‐120 min), between 2 to 4 hours (120‐240 min) at each visit. A 24‐hour urine sample (collected between 240 min and 24 hours the following day) will be collected at each visit.] The difference in I (iodine) in plasma/serum between SWM and CON.[Plasma concentration of I (iodine) will be measured using inductively coupled plasma mass spectrometry (ICP‐ MS) as appropriate. Before the intervention begins (at 0 min), and at 60, 120, 180, and 240 min post‐ingestion at each visit.] The difference in individual amino acid appearance in peripheral circulation between SWM and CON.[Individual plasma amino acids (essential and non‐essential) will be assayed by UHPLC. Amino acids will be assessed as both individual outcomes and composite outcomes. Essential amino acids which include: histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, and valine (individual and composite); non‐essential amino acids which include: alanine, arginine, asparagine, aspartic acid, glutamine, glutamic acid, glycine, proline, serine, and tyrosine (individual and composite). ; Before the intervention begins (at 0 min), and at 30, 60, 90, 120, 180, 240 min post‐ingestion at each visit.] The difference in insulin responses between SWM and CON.[Plasma concentration of insulin as measured by electro chemiluminescent and colorimetric assays. Before the intervention begins (at 0 min), and at 30, 60, 90, 120, 180, and 240 min post‐ingestion at each visit.] The difference in K (potassium) in plasma/serum between SWM and CON.[Plasma concentration of K (potassium) will be measured using colorimetric assays or inductively coupled plasma mass spectrometry (ICP‐ MS) as appropriate. Before the intervention begins (at 0 min), and at 60, 120, 180, and 240 min post‐ingestion at each visit.] The difference in K (potassium) in plasma/serum between SWM and CON.[Plasma concentration of K (potassium) will be measured using inductively coupled plasma mass spectrometry (ICP‐ MS) as appropriate. Before the intervention begins (at 0 min), and at 60, 120, 180, and 240 min post‐ingestion at each visit.] The difference in metabolites of seaweed consumption in plasma between SWM and CON.[The plasma concentration of untargeted exploratory metabolites will be measured independently (not as a composite) using untargeted mass spectrometry methods including Inductively Coupled Plasma Mass Spectrometry (ICP‐MS) and liquid chromatography‐high resolution mass spectrometry (LC‐MS). The specific metabolites and number are as yet unknown. Before the intervention begins (at 0 min), and at 60, 120, 180, and 240 min post‐ingestion at each visit.] The difference in Mg (magnesium) in plasma/serum between SWM and CON.[Plasma concentration of Mg (magnesium) will be measured using colorimetric assays or inductively coupled plasma mass spectrometry (ICP‐ MS) as appropriate. Before the intervention begins (at 0 min), and at 60, 120, 180, and 240 min post‐ingestion at each visit.] The difference in Na (sodium) in plasma/serum between SWM and CON.[Plasma concentration of Na (sodium) will be measured using colorimetric assays or inductively coupled plasma mass spectrometry (ICP‐ MS) as appropriate. Before the intervention begins (at 0 min), and at 60, 120, 180, and 240 min post‐ingestion at each visit.] The difference in postprandial triglycerides response between SWM and CON.[Plasma concentration of postprandial triglycerides as measured by colorimetric assays. Before the intervention begins (at 0 min), and at 30, 60, 90, 120, 180, and 240 min post‐ingestion at each visit.] The difference in subjective appetite responses between SWM and CON.[Appetite score will be analysed using a 100 mm visual analogue scale (VAS). Appetite scores will be completed by the participants upon arrival, immediately before and after study meal consumption, and 30, 60, 90, 120, 180, 240 mins post‐ingestion at each visit.] The difference in subjective digestive comfort responses (patient‐reported outcomes regarding comfort) between SWM and CON.[A visual analogue scale (VAS). A visual analogue scale (VAS) completed by the participants upon arrival, immediately before and after study meal consumption, and 30, 60, 90, 120, 180, and 240 mins post‐ingestion.] The difference in subjective digestive symptoms responses (patient‐reported outcomes regarding symptoms) between SWM and CON.[A visual analogue scale (VAS). A visual analogue scale (VAS) completed by the participants upon arrival, immediately before and after study meal consumption, and 30, 60, 90, 120, 180, and 240 mins post‐ingestion.] The difference in untargeted minerals in plasma/serum between SWM and CON.[Plasma concentration of untargeted minerals will be measured using inductively coupled plasma mass spectrometry (ICP‐ MS). The minerals will be assessed independently. Before the intervention begins (at 0 min), and at 60, 120, 180, and 240 min post‐ingestion at each visit.] The sensory evaluation (acceptability) responses between SWM and CON.[Sensory evaluation (acceptability) will be assessed using lexicon descriptors and sensory attributes of meals. This will be completed by the participants after study meal consumption at each visit.] INCLUSION CRITERIA: a) Adult (18‐60 years). Female participants must declare the stage of the menstrual cycle during the different study phases, if applicable. b) A BMI between 18 and 30 kg/m2.
Epistemonikos ID: 7bdf3354e334050cde3d433efc06f8a8b6b6deb3
First added on: Aug 28, 2024