Effect of Agave Inulin Supplementation on Metabolic Profile and Intestinal Abundance of Bifidobacterium and Lactobacillaceae in Adults With Type 2 Diabetes Mellitus (INULIN-DM2)
Effects of Eight Weeks of Agave Inulin Supplementation on Metabolic Profile and Intestinal Abundance of Bifidobacterium and Lactobacillaceae in Adults With Type 2 Diabetes Mellitus: A Randomized, Double-Blind, Placebo-Controlled Trial
연구 개요
상태
상세 설명
This randomized, double-blind, placebo-controlled, parallel-group clinical trial will evaluate the effects of agave inulin supplementation on metabolic profile and intestinal abundance of Bifidobacterium and Lactobacillaceae in adults with type 2 diabetes mellitus (T2DM).
Participants will be randomly assigned to receive either agave inulin (10 g/day) or placebo for eight weeks. The intervention will be administered as two daily doses of 5 g consumed before breakfast and before dinner.
Metabolic assessments will be performed at baseline and week 8 and will include fasting glucose, fasting insulin, glycated hemoglobin (HbA1c), insulin resistance (HOMA-IR), total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides. Anthropometric and body composition measurements, including body weight, body mass index (BMI), waist circumference, body fat percentage, and muscle mass percentage, will also be evaluated.
Fecal samples will be collected at baseline and week 8, preserved in DNA/RNA Shield solution, and stored at -80°C until analysis. Microbial DNA will be extracted using the ZymoBIOMICS™ DNA Miniprep Kit. Gut microbiota characterization will be performed through 16S rRNA gene sequencing of the V4 hypervariable region using primers 515F and 806R on the Illumina MiSeq platform. Bioinformatic analyses will be conducted using the QIIME pipeline to determine the abundance of Bifidobacterium and Lactobacillaceae. Statistical analyses will be performed according to the intention-to-treat principle.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Querétaro
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Querétaro City, Querétaro, 멕시코, 76230
- Facultad de Ciencias Naturales, Campus Juriquilla
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Confirmed diagnosis of type 2 diabetes mellitus.
- Age between 20 and 75 years.
- Residence in Querétaro, Mexico.
- Stable oral hypoglycemic treatment and/or basal insulin.
- Ability to provide informed consent.
Exclusion Criteria:
- HbA1c > 9.5%.
- Current use of probiotics, prebiotics, synbiotics, or fiber supplements within the previous 3 months.
- Use of alpha-glucosidase inhibitors.
- Severe cardiovascular disease.
- Chronic kidney disease stage 3b or higher.
- Active gastrointestinal disease.
- Pregnancy or lactation.
- Known allergy to agave or fructans.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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위약 비교기: Maltodextrin Placebo
Participants will receive 10 g/day of maltodextrin, administered as two daily doses of 5 g before breakfast and dinner, for 8 weeks.
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Participants will receive 10 g/day of maltodextrin, administered as two daily doses of 5 g before breakfast and dinner, for 8 weeks.
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실험적: Agave Inulin
Participants will receive 10 g/day of agave inulin, administered as two daily doses of 5 g before breakfast and dinner, for 8 weeks.
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Participants will receive 10 g/day of agave inulin, administered as two daily doses of 5 g before breakfast and dinner, for 8 weeks.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in glycated hemoglobin (HbA1c)
기간: Baseline and Week 8.
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Glycated hemoglobin concentration (%) measured in venous blood samples to assess long-term glycemic control.
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Baseline and Week 8.
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Change in insulin resistance (HOMA-IR
기간: Baseline and Week 8.
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Insulin resistance estimated using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), calculated as [fasting glucose (mg/dL) × fasting insulin (μU/mL)]/405.
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Baseline and Week 8.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in fasting plasma glucose
기간: Baseline and Week 8.
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Fasting plasma glucose concentration (mg/dL) measured after a 12-hour overnight fast.
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Baseline and Week 8.
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Change in fasting insulin
기간: Baseline and Week 8.
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Fasting serum insulin concentration (μU/mL) measured after a 12-hour overnight fast.
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Baseline and Week 8.
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Change in total cholesterol
기간: Baseline and Week 8.
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Serum total cholesterol concentration (mg/dL).
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Baseline and Week 8.
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Change in LDL-cholesterol
기간: Baseline and Week 8.
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Serum low-density lipoprotein cholesterol concentration (mg/dL).
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Baseline and Week 8.
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Change in HDL-cholesterol
기간: Baseline and Week 8.
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Serum high-density lipoprotein cholesterol concentration (mg/dL).
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Baseline and Week 8.
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Change in triglycerides
기간: Baseline and Week 8.
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Serum triglyceride concentration (mg/dL).
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Baseline and Week 8.
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Change in intestinal abundance of Bifidobacterium
기간: Baseline and Week 8.
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Relative abundance of Bifidobacterium determined from fecal samples using 16S rRNA gene sequencing.
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Baseline and Week 8.
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Change in intestinal abundance of Lactobacillaceae
기간: Baseline and Week 8.
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Relative abundance of Lactobacillaceae determined from fecal samples using 16S rRNA gene sequencing.
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Baseline and Week 8.
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Change in body weight
기간: Baseline and Week 8.
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Body weight measured in kilograms using standardized procedures.
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Baseline and Week 8.
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Change in body mass index (BMI)
기간: Baseline and Week 8.
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Body mass index calculated as weight (kg)/height (m²).
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Baseline and Week 8.
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Change in waist circumference
기간: Baseline and Week 8.
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Waist circumference measured in centimeters using a non-elastic measuring tape.
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Baseline and Week 8.
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Change in body fat percentage
기간: Baseline and Week 8.
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Body fat percentage assessed by bioelectrical impedance analysis.
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Baseline and Week 8.
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Change in muscle mass percentage
기간: Baseline and Week 8.
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Muscle mass percentage assessed by bioelectrical impedance analysis.
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Baseline and Week 8.
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
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
- 011FCN2024
- UNIVERSİTY (기타 식별자: KAHRAMANMARAŞ SÜTÇÜ İMAM UNİVERSİTY)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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