The Effect of Functional Dairy Products Enriched With Dietary Fibers on Human Health and Gut Microbiota
The purpose of this dietary intervention is to study the effects of dietary fibers on the gut microbiota and use yoghurt as the carrier.
Hypothesis 1: Intake of dietary fibers improves the blood lipid profile of the participants.
Hypothesis 2: Intake of dietary fibers stabilizes the gut microbiome (e.g., low diversity) of the participants, improves gut health and normalizes gastrointestinal function and bowel habits.
연구 개요
상세 설명
The study design is a parallel randomized, prospective, pre-post intervention trial. The main goal of this study is to investigate the effect of the dietary fibers in an unsweetened yoghurt. Fermented dairy products have naturally a very low dietary fiber content, but such products can be supplemented with variety of dietary fibers and promote the growth of beneficial gut bacteria. Also, as fermented milk products contain live bacteria, it is possible that prebiotic fibers could support the growth of the starter-culture based strains in the human gut.
PRE-STUDY EVALUATION AND TESTING
- Complete pre-study questionnaire
- Complete orientation to the study and provide voluntary consent to join the study
- Collection of coded intervention products, sampling supplies, and instructional materials 0-WEEK QUESTIONNAIRE AND LABORATORY VISIT
1. Record food intake and gastrointestinal function for 3 days 2. Collect health data and provide a 3-day food frequency questionnaire 3. Provide a stool and blood sample at the laboratory 2-WEEK QUESTIONNAIRE AND LABORATORY VISIT
- Record food intake and gastrointestinal symptoms for 3 days
- Collect health data and provide a 3-day food frequency questionnaire
- Provide a stool and blood sample at the laboratory BLOOD SAMPLE ANALYSES
1. Provide the blood sample at the laboratory in the morning in an overnight fasted state.
DIETARY INTERVENTION
1. Daily intake of a test or control product for two weeks.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Harjumaa
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Tallinn, Harjumaa, 에스토니아, 12618
- Center of Food and Fermentation Technologies
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age 25-55
- Normal bowel function
- Regular consumer of dairy products, willing to consume dairy products daily for 2 weeks
- Ability to provide a signed written informed consent
- Willing to provide stool and blood specimens 2 times over the 2-week study period
Exclusion Criteria:
- Diagnosed history of chronic diseases including coronary heart disease, stroke, cancer, type 1 or 2 diabetes mellitus, inflammatory bowel disease, gastritis, autoimmune disease, or rheumatoid arthritis
- Medication: statins, blood pressure medications, antidepressants, other prescription medications
- History of bariatric operation, removal of the gallbladder.
- Food allergies, lactose intolerance
- Recent (previous 3 months) use of antibiotics
- Intake of highly dosed pre- or probiotics 2 weeks prior and during the study
- Current pregnancy or breastfeeding
- Volunteers showing previously unrecognized illness will also be excluded
- Individual unable to give informed consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Test group
Healthy adults consuming test product
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200 g/day of unsweetened yogurt supplemented with a dietary fiber blend
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위약 비교기: Control group
Healthy adults consuming control product
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200 g/day of unsweetened yogurt
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Evaluation of the intestinal microbiota
기간: 14 days
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Fecal microbiota analysis based on the 16S rRNA sequencing pre- and post-dietary intervention.
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14 days
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Evaluation of blood lipid profile
기간: 14 days
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Triglycerides, total cholesterol, HDL-cholesterol, LDL-cholesterol pre- and post-dietary intervention in plasma (mmol/L).
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14 days
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Evaluation of blood glucose levels
기간: 14 days
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Fasting glucose pre- and post-dietary intervention in plasma (mmol/L).
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14 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Evaluation of the stool form
기간: 14 days
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Stool form will be assessed using a validated 7-point scale called Bristol Stool Form Scale pre- and post-dietary intervention.
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14 days
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Evaluation of the defecation frequency
기간: 14 days
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14 days
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Evaluation of the defecation timing
기간: 14 days
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Evacuation timing 3 days before sampling pre- and post-dietary intervention.
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14 days
|
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Evaluation of the gastrointestinal symptoms
기간: 14 days
|
Frequency and severity of the gastrointestinal symptoms (Constipation, Diarrhea, Bloating, Flatulence, Cramps, Stomach pain).
Scale of frequency: Never, Less than 10 times a year, Once a month, Once a week, Every day.
Scale of severity: I do not have any gastrointestinal symptoms, Mild (does not disturb), Moderate, Strong (disturbs considerably).
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14 days
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Evaluation of the blood vitamin D status
기간: 14 days
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25-OH vitamin D pre- and post-dietary intervention in plasma.
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14 days
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공동 작업자 및 조사자
수사관
- 수석 연구원: Madis Jaagura, MSc, TFTAK
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Anonymized participant data could be made available for subsequent analysis in the mentioned institution (TFTAK).
Data made public will include only aggregates or summaries of the collected data.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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