ISRCTN41452843已完成不适用
A study to investigate the effect of probiotics in combination with fish oil on metabolic risk factors in overweight and obese subjects following caloric restriction diet
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cultech Ltd
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Adults aged = 18 years
- •2. BMI between 25 to 35 kg/m2
- •3. Participants are willing to give written informed consent
- •4. Participants who are willing to follow the caloric restricted diet for 8 weeks of the study period
- •5. Participants who are willing to avoid the use of other weight loss products during the study period
- •6. Participants who are willing to provide blood samples
- •7. Participants who are willing to avoid other probiotic, fish oil or oily fish use for the duration of the study
排除标准
- •1. Participants who have BMI = 24.9 kg/m2 and = 36 kg/m2
- •2. Participants who are unable/unwilling to give written informed consent
- •3. Participants who are not prepared to provide blood samples as required
- •4. Participants with known or suspected food allergy or intolerance to one of the intervention products' components.
- •5. Participants who refuse to stop taking any probiotics supplements, dairy probiotic product (yoghurt with biocultures, Acidophilus milk, kefir, Actimel, Yakult, etc) and omega 3/fish oil supplements apart from the intervention products during the study period
- •6. Participants who have undergone bariatric surgery
- •7. Participants with three months of weight instability before study enrolment or known history of eating disorders (anorexia nervosa, bulimia nervosa)
- •8. Participants with diabetes mellitus 1st and 2nd type
- •9. Participants with personal history of severe chronic diseases (cancer, HIV, kidney failure, liver damage, diagnosed gastrointestinal disorders, arthritis, chronic respiratory failure, etc)
- •10. Pregnant or breastfeeding women or intending to become pregnant within next 3 months
- •11. Participants who had taken antibiotics within 4 weeks prior to enrolment
- •12. Participants with alcohol intakes > 14 units/week or 3 units/day
- •13. Participants fitted with any electronic implantable device (contraindicated for bioelectrical impedance analysis)
研究者
相似试验
已完成
不适用
A study to investigate the effect of probiotics on faecal flora - does administration of the probiotic 'Acidophilus' reduce counts of Enterobacteriaceae in the intestines of healthy volunteers?ISRCTN26317136Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
已完成
不适用
Effect of probiotics following antibiotic therapyOral antibiotic therapyInfections and InfestationsISRCTN16359093Cultech Ltd78
已完成
不适用
A study to investigate effects of Probiotics (Bifidobacteria) ingestion on visceral fat area in overweight adult: a randomized, double blind, placebo controlled study.oneJPRN-UMIN000023919KSO Corporation80
招募中
3 期
Study the effects of probiotic supplementation on polycystic ovary syndromePolycystic ovary syndome.Polycystic ovarian syndromeIRCT20180404039187N3Tabriz University of Medical Sciences84
已完成
3 期
A trial of the effect of probiotics on the development of atopy and eczema in childreACTRN12607000518460niversity of Otago510