NIPH Clinical Trials Search

A randomized double-blind placebo-controlled trial for improving the intestinal environment in human

Basic Information

Recruitment status	Complete: follow-up complete
Health condition(s) or Problem(s) studied	Healthy adults
Date of first enrollment	2015/09/10
Target sample size	24
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	Period: 4 weeks Test food: Baker's yeast extract (0.5 g) Dose: three times a day (0.5 g for once) Usage: ingestion of the test food along with the water or hot water after each meals Period: 4 weeks Test food: Baker's yeast extract {Baker's yeast extract (0.08 g)+ dextrin (0.42 g)} Dose: three times a day (0.5 g for once) Usage: ingestion of the test food along with the water or hot water after each meals Period: 4 weeks Test food: Placebo (dextrin; 0.5 g) Dose: three times a day (0.5 g for once) Usage: ingestion of the test food along with the water or hot water after each meals

Outcome(s)

Primary Outcome	Intestinal bacterial flora (T-RFLP)
Secondary Outcome	1. Intestinal bacterial flora (real-time PCR) 2. T-regulatory cell (T-reg) 3. The Japanese Version of the Constipation Assessment Scale MT version (CAS-MT)

Key inclusion & exclusion criteria

Age minimum	20years-old
Age maximum	Not applicable
Gender	Male and Female
Include criteria
Exclude criteria	1. At least one previous medical history of malignant tumor, heart failure or myocardial infarction 2. Currently under the treatment for either atrial fibrillation, cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, digestive disease (include colonic diverticulosis, ulcerative colitis, Diverticular Disease of the Colon) or other chronic diseases 3. Currently taking medicines, herbal medicines 4. Usually taking Food for Specified Health Uses (FOSHU), Functional Labeling System on health foods, yogurt or lactic acid bacteria beverage, which are related with intestinal regulation. 5. Allergic to medicines or foods related to the test food of this trial 6. Usually taking supplements or nutrient function foods in daily 7. Pregnant, lactating, or planning to get pregnant during the trial period 8. Enrolled into other clinical trials within the last 3 months before agreeing to participate in this trial 9. Judged unsuitable for participating in this trial by physician