Postprandial Effects of Fresh Mango as a Table Sugar Replacement in High-Sugar Breakfasts.
Effects of Fresh Mango as a Table Sugar Replacement on Postprandial Intestinal Permeability and Inflammation Following a High-Sugar Breakfast.
연구 개요
상태
정황
상세 설명
The investigators will use banked serum samples from an ongoing randomized crossover study to determine the effects of fresh mango as a substitute for added sugar on postprandial glucose and insulin in the context of high glycemic and low glycemic breakfasts. The investigators will use samples banked from the high glycemic meals and compare indicators of intestinal permeability and inflammation following corn flakes + fresh mango and corn flakes + sucrose. the samples come from recruited individuals with a BMI in the 18.5-35.0 kg/m2 range from the Ball State University campus and surrounding communities. Each participant (N=35) will complete two meal trials in random order. An indwelling intravenous catheter (IV) is placed in a forearm vein and a baseline blood sample is collected. Next, participants will consume one of the two test meals: (1) corn flakes with 2% milk + fresh mango and (2) corn flakes with 2% milk + sucrose. Corn flakes based meals reflect a commonly consumed breakfast food with high glycemic index. In each meal, total sugar (grams) will be identical, meals are nearly isocaloric (+/- ≤ 4 kcal) and macronutrients are matched.
After each meal, additional whole blood samples will be collected at 30-, 60-, 120-, and 180 minutes after participants take their first bite of food. Blood is collected into serum separator tubes, allowed to clot, centrifuged, and stored at -80 degrees C until study completion. Serum LPS, LBP, and sCD14 will be assayed in duplicate at all timepoints as indicators of intestinal permeability. Direct LPS measurement will be carried out using a cutting-edge assay (Pyrogene rFC; Lonza) that detects LPS in a single enzymatic step. LPS assays will be conducted with LPS-free consumables in sterile biosafety cabinet. LBP and sCD14 will be measured with commercially available ELISAs. Serum IL-6 will be assayed in duplicate at all time points as a measure of inflammation. IL-6 analyses will be measured externally at the Indiana University School of Medicine Translational Core on a high-sensitivity single-plex assay.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Bryant Keirns, PhD
- 전화번호: 765-285-8356
- 이메일: bryant.keirns@bsu.edu
연구 장소
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Indiana
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Muncie, Indiana, 미국, 47306
- 모병
- Health Professions Building, Ball State University
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연락하다:
- Bryant Keirns, PhD
- 전화번호: 765-285-8356
- 이메일: bryant.keirns@bsu.edu
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- 18 - 45 years.
- Body mass index between 18.5-35.0 kg/m2
- Not pregnant or expecting to become pregnant (females only)
- Not postmenopausal (females only).
- No known chronic medical conditions (e.g., type 2 diabetes, cardiovascular disease, inflammatory diseases, etc.)
- No history of using tobacco/illicit drugs
- No history of using glucose-lowering medications/supplements.
- No history of using prescribed anti-inflammatory medications
- Does not use over-the-counter anti-inflammatory medications ≥2x/week
- Does not have a pacemaker.
- No relevant food allergies/intolerances
- Able to lay supine for at least ten minutes.
Exclusion Criteria:
- Not between the ages of 18-45
- Body mass index < 18.5 kg/m2 or >35.0 kg/m2
- Pregnant (females only)
- Postmenopausal status (females only).
- Been diagnosed with a chronic medical conditions (e.g., type 2 diabetes, cardiovascular disease, inflammatory diseases, etc.)
- Uses tobacco products or any illicit drugs.
- Uses glucose-lowering drugs/supplements.
- Regularly takes anti-inflammatory drugs (more than 2x week).
- Have a pacemaker.
- Allergic to mango, wheat, gluten, and/or milk.
- Unable to lay in supine position in the dark for at least ten minutes.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 테이블 설탕으로 시리얼 소비
시리얼과 테이블 설탕 팔 중에 참가자들은 테이블 설탕으로 달게 된 2% 우유로 옥수수 조각 한 그릇을 소비합니다.
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High-glycemic breakfast of 84 grams of corn flakes prepared with 355 mL of 2% milk and sweetened with 36 grams of table sugar.
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실험적: Cereal Consumption with Fresh Mango
During the Cereal and Fresh Mango arm, participants will consume a bowl of corn flakes with 2% milk sweetened with fresh mango.
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High-glycemic breakfast of 84 grams of corn flakes prepared with 355 mL of 2% milk and sweetened with 262 grams of fresh mango.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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LPS
기간: Through study completion, up to 1 year.
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The investigators will measure LPS at baseline and 30-, 60-, 120-, and 180- minutes after each meal.
These measurements will take place immediately and a complete dataset will be compiled upon study completion.
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Through study completion, up to 1 year.
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LPS Binding Protein
기간: Through study completion, up to 1 year.
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The investigators will measure LPS binding protein at baseline and 30-, 60-, 120-, and 180-minutes after each meal.
These measurements will take place immediately and a complete dataset will be compiled upon study completion.
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Through study completion, up to 1 year.
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IL-6
기간: Through study completion, up to 1 year.
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The investigators will measure IL-6 at baseline and 30-, 60-, 120-, and 180-minutes after each meal.
These measurements will take place immediately and a complete dataset will be compiled upon study completion.
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Through study completion, up to 1 year.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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수용 가능성
기간: 학습 완료를 통해 최대 1 년.
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조사관은 사후 사후에 한 번 각 연구 방문에서 설문 조사를 통해 각 식사의 수용 가능성을 측정 할 것입니다.
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학습 완료를 통해 최대 1 년.
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sCD14
기간: Through study completion, up to 1 year.
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The investigators will measure soluble CD14 at baseline and 30-, 60-, 120-, and 180-minutes after each meal.
These measurements will take place immediately and a complete dataset will be compiled upon study completion.
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Through study completion, up to 1 year.
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Satiety
기간: Through study completion, up to 1 year.
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The investigators will measure satiety through a survey at baseline and at 30-, 60-, 90-, 120-, 150-, and 180-minutes after the meal.
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Through study completion, up to 1 year.
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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체성분
기간: 학습 완료를 통해 최대 1 년.
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연구자들은 생체 전기 임피던스 (Inbody)를 사용하여 체성분을 측정 할 것입니다.
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학습 완료를 통해 최대 1 년.
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공동 작업자 및 조사자
수사관
- 수석 연구원: Bryant Keirns, PhD, Ball State University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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
- IRB-FY2025-25-1
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
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