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Prebiotics and Immune Function in Middle Aged Humans

Investigation of the Effects of a Prebiotic Supplement on Immune Function in Healthy Human Adults

Prebiotics are naturally occurring carbohydrates found in a variety of edible plants. They are not digested by mammalian enzymes, and so reach the gut intact, where they are fermented by some species of intestinal bacteria. This fermentation is thought to have several benefits for the host including improving immune function. There are numerous methods available for assessing the human immune response. Response to vaccination is thought to be a good method for this. Not many studies have examined the effect of prebiotics on the human immune response to vaccination. Thus the investigators propose to test the effect of a prebiotic on the immune response in healthy volunteers including their response to the current flu vaccine. The investigators hypothesise that the prebiotic will enhance the immune response including the response to the vaccine.

연구 개요

상세 설명

Prebiotics are naturally occurring carbohydrates found in a variety of edible plants. They are not digested by mammalian enzymes, and so reach the gut intact, where they are fermented by some species of intestinal bacteria. This fermentation is thought to have several benefits for the host including improving the immune response. Inulin-type fructans (oligofructose and inulin) are classified as prebiotics. Inulin is found naturally in significant amounts in a variety of plants foods, such as bananas, leeks, onions, artichokes, wheat and chicory. Synergy1 is a prebiotic preparation produced by Beneo-Orafti, and containing a mixture of oligofructose and inulin derived from chicory. Fructooligosaccharides including Synergy1 are widely used by the food industry and are commonly found as a source of insoluble fibre in many biscuit, bakery, cereal and dairy products.

There is increasing evidence that the changes in the intestinal microflora that occur with the consumption of fructooligosaccharides can modulate immune parameters, not only in the gut-associated lymphoid tissue, but also secondary lymphoid tissues and the peripheral circulation. Much of the evidence for beneficial effects of fructooligosaccharides on immune function comes from animal models e.g. rats, mice, dogs and pigs. Results from these studies show that the innate and adaptive immune systems of both the gut associated lymphoid tissue and the systemic immune system can be modified by fructooligosaccharides. However, there are few human studies so far which have investigated the effects of prebiotics on immune function, and these studies mostly rely on systemic markers of immunity. The results show little effect of fructooligosaccharides on innate immune function, but mixed results are reported regarding the adaptive immune system, suggesting that there may by improvement on this aspect of immunity with increased intake of fructooligosaccharides. The small number of published human studies led Watzl et al. (2005) to suggest that more human studies are needed to find out whether inulin and/or oligofructose have the potential to modulate systemic immunity in well-nourished individuals.

There are numerous methods available for assessing the human immune response. These have been evaluated by a panel of European experts (Albers et al. 2005). Based on its biological relevance, sensitivity and practical feasibility, response to vaccination was identified by this panel as the gold standard for measuring the functioning of the immune system in vivo (Albers et al. 2005). A small number of studies have studied the effect of fructooligosaccharides on the human immune response using vaccination response as the outcome, but only four of these examined fructooligosaccharides in the absence of other additional nutrients and of these two studies were in infants. Thus, the number of studies examining the immunologic impact of fructooligosaccharides in adult humans and using the gold standard outcome is very limited. From a public health perspective, it would be of importance, if fructooligosaccharides can improve immune function especially in older adults who are at risk of age-related immune decline. Thus, we propose to use a commercially available influenza vaccine (Imuvac®) to stimulate the immune response in healthy human adults, and to use this to assess the effect of a well defined prebiotic preparation commonly used in the food industry (Synergy1).

연구 유형

중재적

등록 (실제)

49

단계

  • 2 단계
  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Southampton, 영국, SO16 6YD
        • University of Southampton

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

45년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

Inclusion Criteria:

  1. Aged 45-65 years
  2. Body mass index 20 to 32 kg/m2.
  3. Not consuming probiotic supplements, yoghurts, drinks or other foods
  4. Not consuming prebiotic supplemented drinks or foods
  5. In general good health
  6. No antibiotic use in the 2 months prior to entering the study or during the study
  7. Not been vaccinated with the current season's influenza vaccine
  8. Being able to provide written informed consent

Exclusion Criteria:

  1. Aged < 45 or > 66 years
  2. Body mass index < 20 or > 32 kg/m2.
  3. Being diabetic (type 1 or type 2)
  4. Displaying manifestations of allergy - asthma, hay-fever, dermatitis - or being treated for these
  5. Being egg allergic
  6. Use of any prescribed medicine (unless deemed to be acceptable by the PI)
  7. Suffering from any infectious illness
  8. Chronic gastrointestinal problems (e.g. IBD, IBS, cancer)
  9. Recent blood donation
  10. Participation in another clinical trial
  11. Use of prebiotic or probiotic supplements, foods or drinks
  12. Consuming vitamin, mineral or oil supplements
  13. Previously vaccinated with the influenza vaccine being used.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 기초 과학
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: 말토덱스트린
위약으로서의 말토덱스트린
다른 이름들:
  • 말토덱스트린
실험적: Prebiotic
Inulin type fructooligosaccharides
Inulin type fructooligosaccharides
다른 이름들:
  • 시너지1

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Serum anti-vaccine antibody concentrations
기간: Weeks 2 and 4 post-vaccination
Weeks 2 and 4 post-vaccination

2차 결과 측정

결과 측정
기간
Serum total antibody (IgG, IgA, IgM) concentrations
기간: Weeks -4, 0, 2 and 4 with respect to vaccination
Weeks -4, 0, 2 and 4 with respect to vaccination
Innate immune responses - neutrophil and monocyte phagocytosis and respiratory burst
기간: Weeks -4, 0, 2 and 4 with respect to vaccination
Weeks -4, 0, 2 and 4 with respect to vaccination
Ex vivo T lymphocyte responses to mitogen (activation, proliferation and cytokine production)
기간: Weeks -4, 0, 2 and 4 with respect to vaccination
Weeks -4, 0, 2 and 4 with respect to vaccination
Ex vivo T lymphocyte responses to vaccine (activation, proliferation and cytokine production)
기간: Weeks 0, 2 and 4 with respect to vaccination
Weeks 0, 2 and 4 with respect to vaccination
Ex vivo natural killer cell activity
기간: Weeks -4, 0, 2 and 4 with respect to vaccination
Weeks -4, 0, 2 and 4 with respect to vaccination
Faecal microflora
기간: Weeks -4 and 0 with respect to vaccination
Weeks -4 and 0 with respect to vaccination
Salivary IgA concentration
기간: Weeks -4, 0, 2 and 4 with respect to vaccination
Weeks -4, 0, 2 and 4 with respect to vaccination

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Philip C Calder, PhD, University of Southampton

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2009년 4월 1일

기본 완료 (실제)

2009년 10월 1일

연구 완료 (실제)

2010년 7월 1일

연구 등록 날짜

최초 제출

2009년 4월 20일

QC 기준을 충족하는 최초 제출

2009년 5월 11일

처음 게시됨 (추정)

2009년 5월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2014년 12월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2014년 11월 26일

마지막으로 확인됨

2010년 7월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • RHMNUT0055

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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