Glycaemic Response of Arabic Bread
Glycaemic Response to Arabic Bread Formulated With Alternative Flour Blends: A Comparison With Arabic Wheat Bread
Bread remains one of the most widely consumed staple foods worldwide, with wheat flour serving as its traditional foundation. However, the widespread dependence on refined wheat-based bread has paralleled the rising prevalence of type 2 diabetes (T2D), partly owing to its high glycaemic index (GI), which results in rapid increases in blood glucose levels. Enhancing the nutritional quality of bread, therefore, represents an important target for dietary intervention.
Developing alternative flour blends for bread production presents a potential strategy for improving glycaemic control and supporting glucose homeostasis. Accordingly, this clinical trial aims to determine whether the partial replacement of wheat flour with legume flours, including chickpea, pea, and lentil, in Arabic bread formulations can lower glycaemic responses compared with traditional Arabic wheat bread.
調査の概要
状態
詳細な説明
This study will be a crossover trial. Participants living with overweight and obesity will be recruited and fully informed about the study before giving informed consent. Eligible participants will attend the University of Nottingham on 4 separate visits following an overnight fast of at least 10 hours. On each visit, participants will consume one of three Arabic bread formulations or a control, with a one-week washout between visits. Each bread sample will provide an equivalent of 50 g of available carbohydrate:
- Control bread (100% wheat flour)
- Arabic bread containing 30% chickpea flour, with 70% wheat flour (primary comparison with control)
- Arabic bread containing 30% pea flour, with 70% wheat flour(optional secondary comparison with control)
- Arabic bread containing 30% lentil flour, with 70% wheat flour (optional secondary comparison with control)
The primary focus of this study is the comparison between the control bread and the chickpea-enriched bread, as chickpea flour represents the main intervention. The pea-enriched bread and lentil-enriched variants are included as optional secondary comparisons to provide additional insights into the broader effect of legume flour substitution on glycaemic response.
Study Visits:
The procedures for each visit are summarised below:
- Pre-visit fast: Participants will fast for at least 10 hours before each visit.
- Blood glucose sampling: Capillary blood glucose will be measured via finger prick at baseline and at regular intervals over 120 minutes following consumption (0, 15, 30, 60, 90, and 120 min) of the bread sample to assess the postprandial glycaemic response.
- Appetite assessment: Participants will complete visual analogue scale questionnaires at baseline and at set intervals throughout each visit to assess subjective appetite responses.
- Sensory evaluation: Participants will be asked to rate the sensory acceptability of each bread sample using a 9-point hedonic scale immediately after consumption.
- Dietary intake: Participants will complete 24-hour food diaries in each visit.
Gastrointestinal symptoms will also be monitored via a brief self-reported questionnaire at baseline and post-consumption.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Wejdan Shamakhay, Phd Student
- 電話番号：+44
- メール：alyws7@nottingham.ac.uk
研究連絡先のバックアップ
- 名前：Simon Welham, Associate Professor
- メール：simon.welham@nottingham.ac.uk
研究場所
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Nottingham、イギリス
- School of Biosciences, University of Nottingham, Sutton Bonington Campus, United Kingdom
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コンタクト：
- Simon Welham, Associate Professor
- 電話番号：0115 951 6129
- メール：simon.welham@nottingham.ac.uk
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コンタクト：
- Wejdan Shamakhay, PhD Student
- メール：alyws7@nottingham.ac.uk
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主任研究者：
- Wejdan Shamakhay, PhD student
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主任研究者：
- Simon Welham, Associate Professor
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Participants will be adults living with overweight or obesity (Body Mass Index [BMI] > 25 kg/m²).
- Participants will be of any gender.
- Participants will be aged 18 to 65.
- Participants will be from any sociodemographic background.
- Participants will be able to provide informed consent.
- Participants will be able to understand spoken and written English and be able to record their responses to questionnaires.
Exclusion Criteria:
- Those with food allergies or intolerances to any of the study ingredients, including wheat, chickpeas, lentils, or peas, will not be eligible.
- Individuals with a known diagnosis of metabolic or chronic health conditions, such as diabetes, insulin resistance, hypertension, or phenylketonuria, will be excluded due to the potential impact on glycaemic control and study outcomes.
- Participants with a fasting blood glucose level of above 7.0 mmol/L.
- Use of medications that influence blood glucose levels (e.g., corticosteroids, antipsychotics, antiviral protease inhibitors) or substances that interfere with digestion and absorption (such as laxatives or fibre supplements) will result in exclusion.
- Pregnant or breastfeeding individuals will not be included due to the physiological changes that may influence study outcomes.
- Participants with implanted medical devices, including pacemakers, artificial organs, defibrillators, or joint replacements, will be excluded for safety considerations.
- Anyone who has undergone major surgery or hospitalisation within the last 5 months will be deemed ineligible.
- Individuals who have participated in another research study involving invasive procedures within the last 3 months will be excluded.
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：Control bread followed by chickpea bread
Participants will consume control Arabic bread followed by chickpea-enriched Arabic bread after the one week's washout period.
Participants who complete the primary crossover phase may optionally continue to pea and/or lentil bread interventions.
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Arabic bread prepared with 100% wheat flour, providing an equivalent of 50g of available carbohydrate.
Arabic bread prepared with 30% chickpea flour and 70% wheat flour, providing an equivalent of 50g available carbohydrate. (This is the primary experimental comparison) Arabic bread prepared with 30% pea flour and 70% wheat flour, providing an equivalent of 50g available carbohydrate. (Optional secondary comparison) Arabic bread prepared with 30% lentil flour and 70% wheat flour, providing an equivalent of 50g available carbohydrate. (Optional secondary comparison) |
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実験的：Chickpea bread followed by control bread
Participants will consume chickpea-enriched Arabic bread followed by control Arabic bread after one week the washout period.
Participants who complete the primary crossover phase may optionally continue to additional exploratory bread interventions, including pea bread and/or lentil bread.
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Arabic bread prepared with 100% wheat flour, providing an equivalent of 50g of available carbohydrate.
Arabic bread prepared with 30% chickpea flour and 70% wheat flour, providing an equivalent of 50g available carbohydrate. (This is the primary experimental comparison) Arabic bread prepared with 30% pea flour and 70% wheat flour, providing an equivalent of 50g available carbohydrate. (Optional secondary comparison) Arabic bread prepared with 30% lentil flour and 70% wheat flour, providing an equivalent of 50g available carbohydrate. (Optional secondary comparison) |
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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Postprandial Blood Glucose Response
時間枠：120 minutes
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Differences in the iAUC for capillary blood glucose will be compared between bread formulations.
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120 minutes
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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 |
|---|---|---|
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24時間の食事摂取量
時間枠：24時間
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製品摂取後深夜までの総エネルギー摂取量、主要栄養素の摂取量。
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24時間
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Peak Postprandial Capillary Blood Glucose
時間枠：120 minutes
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Differences in the peak capillary blood glucose value after consuming each bread formulation.
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120 minutes
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Appetite Response
時間枠：120 minutes
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Appetite sensations (hunger, fullness, desire to eat sweet foods, desire to eat salty foods, desire to eat fatty foods, and desire to eat savoury foods) will be assessed using a 100-mm Visual Analogue Scale (VAS).
Scores range from 0 to 100 mm.
Higher scores indicate greater intensity of the appetite sensation being measured (e.g., greater hunger, fullness, or desire to eat).
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120 minutes
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Sensory Acceptability
時間枠：Immediately after consumption
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Sensory acceptability of each Arabic bread sample will be assessed using a 9-Point Hedonic Scale.
Scores range from 1 to 9, with higher scores indicating greater liking and sensory acceptability across sensory attributes, including overall liking, colour, aroma, flavour, texture, chewability, roundness, and crumb characteristics.
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Immediately after consumption
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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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Gastrointestinal Symptoms
時間枠：At baseline (0 minute) and 120 minutes post-consumption
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Participants will complete a brief self-reported gastrointestinal symptom questionnaire pre- and post-consumption to assess symptoms such as bloating, abdominal discomfort, and flatulence.
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At baseline (0 minute) and 120 minutes post-consumption
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
- FMHS 238-0925
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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