Evaluation of the Bioavailability of Amino Acids From Purple Bacteria (PROTEBOOST_1)
Evaluation of the Consumption of Fresh Purple Bacteria Biomass in Healthy Humans: Safety Test and Monitoring of Metabolism
This interventional clinical study aims to evaluate the bioavailability of amino acids derived from purple bacteria in healthy adults. Participants will consume either a protein-enriched dairy product or a protein-enriched dairy product containing purple bacteria during two separate test periods in a randomized cross-over design. Blood amino acid concentrations will be measured over a 4-hour postprandial period to assess amino acid absorption and bioavailability.
Additional biological samples including saliva, exhaled air, and feces will be collected to evaluate gastrointestinal hormones, volatilome profiles, and related metabolic responses.
調査の概要
状態
条件
詳細な説明
Purple bacteria are recognized for their high-quality protein content, including essential amino acids, as well as their vitamin and carotenoid composition. However, limited data are available regarding the bioavailability of amino acids derived from purple bacteria in humans.
This randomized, open-label, cross-over study will enroll approximately 12 healthy adult participants in Belgium. Each participant will receive two dairy-based formulations in randomized order:
Control formulation: protein-enriched dairy product. Test formulation: protein-enriched dairy product containing purple bacteria.
The two intervention periods will be separated by a washout period of at least one week.
Participants will undergo one screening visit and two test visits. During each test visit, serial blood samples will be collected over 240 minutes following ingestion of the assigned formulation to determine plasma amino acid concentrations. Additional saliva, exhaled air, and fecal samples will also be collected.
The primary objective is to determine whether amino acids present in purple bacteria are better absorbed than amino acids from other protein sources.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Louvain-la-Neuve、ベルギー、1348
- Center of Investigation in Clinical Nutrition (CICN)
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Adults aged 18 to 50 years
- Body mass index between 18 and 30 kg/m²
- Healthy participants
- Non-smokers
- Women of childbearing potential using effective contraception
- Able to understand and speak French
- Willing and able to comply with study procedures
Exclusion Criteria:
- Pregnancy or breastfeeding
- Use of medications or dietary supplements incompatible with study participation
- Any medical condition considered by the investigator to interfere with study participation or interpretation of results
- Vegan or vegetarian diets
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Purple Bacteria Formulation
Participants will consume a protein-enriched dairy product containing purple bacteria.
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Approximately 50 g of purple bacteria incorporated into approximately 110 g of a protein-enriched dairy product.
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アクティブコンパレータ：Control Formulation
Participants will consume a protein-enriched dairy product without purple bacteria.
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160 g of protein-enriched dairy product.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in postprandial plasma essential amino acid concentrations (µmol/L)
時間枠：Throughout the entire study, approxiamtely during 1 month
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Plasma concentrations of essential amino acids (including leucine, isoleucine, valine, lysine, threonine, phenylalanine, methionine, tryptophan, and histidine) will be measured using LC-MS/MS at baseline and at multiple postprandial time points following ingestion of control and test formulations.
Results will be reported as incremental area under the curve (iAUC, µmol/L·h) over the postprandial period.
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Throughout the entire study, approxiamtely during 1 month
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in exhaled volatile organic compounds (VOCs) profile (relative abundance, arbitrary units)
時間枠：Throughout the entire study, approxiamtely during 1 month
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Exhaled air samples will be analyzed using gas chromatography-mass spectrometry (GC-MS).
Specific VOCs will be quantified and reported as relative abundance (arbitrary units) and/or multivariate profile changes (e.g., PCA scores) comparing test vs control formulations.
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Throughout the entire study, approxiamtely during 1 month
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Change in salivary gastrointestinal hormone concentrations (pg/mL)
時間枠：Throughout the entire study, approxiamtely during 1 month
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Salivary concentrations of gastrointestinal hormones (e.g., ghrelin, GLP-1, PYY) will be measured using immunoassays.
Results will be expressed as change from baseline and iAUC (pg/mL·h) over the postprandial period.
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Throughout the entire study, approxiamtely during 1 month
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Gastrointestinal symptom severity score assessed using a 5-point Likert scale (0-4)
時間枠：Throughout the entire study, approxiamtely during 1 month
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Gastrointestinal tolerance will be assessed using a standardized symptom questionnaire evaluating the severity of gastrointestinal symptoms (including bloating, abdominal pain, flatulence, nausea, and diarrhea). Each symptom will be rated using a 5-point Likert scale, defined as: 0 = not at all
Results will be reported as: mean gastrointestinal symptom score (average across symptoms) and/or total symptom score (sum of all items; higher scores indicate worse symptoms) and change from baseline over the postprandial period following ingestion of study formulations. |
Throughout the entire study, approxiamtely during 1 month
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Number of participants with at least one adverse event
時間枠：Throughout the entire study, approxiamtely during 1 month
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Adverse events will be collected throughout the study period and reported as the number and proportion of participants experiencing at least one adverse event, by condition.
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Throughout the entire study, approxiamtely during 1 month
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Perceived stress score assessed using the Perceived Stress Scale (PSS-10; range 0-40)
時間枠：Throughout the entire study, approxiamtely during 1 month
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Perceived stress will be assessed using the Perceived Stress Scale (10-item version, PSS-10), a validated questionnaire measuring the degree to which situations in one's life are appraised as stressful. The total score ranges from: 0 to 40, with higher scores indicating higher perceived stress Results will be reported as: mean total PSS score change from baseline over the study period and/or between-group differences following ingestion of the study formulations. |
Throughout the entire study, approxiamtely during 1 month
|
協力者と研究者
捜査官
- 主任研究者：Sylvie Copine, Dr、Université Catholique de Louvain
- 主任研究者：Laurent Simar, Dr、Université Catholique de Louvain
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- PROTEBOOST_BIODISPO1
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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