- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07652320
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Wejdan Shamakhay, Phd Student
- 전화번호: +44
- 이메일: alyws7@nottingham.ac.uk
연구 연락처 백업
- 이름: Simon Welham, Associate Professor
- 이메일: simon.welham@nottingham.ac.uk
연구 장소
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Nottingham, 영국
- School of Biosciences, University of Nottingham, Sutton Bonington Campus, United Kingdom
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연락하다:
- Simon Welham, Associate Professor
- 전화번호: 0115 951 6129
- 이메일: simon.welham@nottingham.ac.uk
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연락하다:
- Wejdan Shamakhay, PhD Student
- 이메일: alyws7@nottingham.ac.uk
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수석 연구원:
- Wejdan Shamakhay, PhD student
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수석 연구원:
- Simon Welham, Associate Professor
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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실험적: 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) |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Postprandial Blood Glucose Response
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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24시간 음식 섭취
기간: 24 시간
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총 에너지 섭취량, 제품 소비 후 자정까지 다량 영양소 섭취.
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24 시간
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Peak Postprandial Capillary Blood Glucose
기간: 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
기간: 120 minutes
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Appetite sensations including hunger, fullness, and desire to eat assessed using visual analogue scales (VAS) at baseline and at regular intervals throughout each visit.
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120 minutes
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Sensory Acceptability
기간: Immediately after consumption
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Overall liking and sensory acceptability of each Arabic bread sample were assessed using the 9-point hedonic scale immediately after consumption.
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Immediately after consumption
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Gastrointestinal Symptoms
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- FMHS 238-0925
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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