Effects of Seaweeds Combined With Probiotics on Intestinal Function of Healthy Subjects

NCT01651741 | Completed DMC

• 1 other identifier: 911029-1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of this study are to investigate the effect of seaweeds which is one of the main ingredients of Korean traditional food 'Kimchi' and probiotics on intestinal function of healthy subjects.

Conditions

Healthy

Keywords

Intestinal Microbiota; Probiotics; Seaweed; Healthy Subject

Outcome Measures

Primary Outcomes (1)

• Change of intestinal microflora (7 strains of Lactic acid bacteria)

  1. To investigate the changes of intestinal microbes before and after experiment, feces should be collected. 2. The feces will be analyzed by the method of DGGE (denaturing gradient gel electrophoresis - PCR of DNA).

  Visit 1(0week), Visit 2(4week)

Secondary Outcomes (3)

• Daily assessment of bowel function scores

  Visit 1(0week), Visit 2(4week), Visit 3(6week)

• KGSRS (Korean gastrointestinal symptom rating scale)

  Visit 1(0week), Visit 2(4week), Visit 3(6week)

• WHOQOL (The World Health Organization Quality of Life) - BREF

  Visit 1(0week), Visit 2(4week), Visit 3(6week)

Study Arms (2)

Seaweed and Duolac7S

EXPERIMENTAL

Seaweed: Real Seaweed granule, Duolac7S: Real probiotics

Dietary Supplement: Seaweed and Duolac7S

Seaweed and Duolac7S-P

PLACEBO COMPARATOR

Seaweed: Real Seaweed granule, Duolac7S-P: Placebo probiotics

Dietary Supplement: Seaweed and Duolac7S-P

Interventions

Seaweed and Duolac7S DIETARY_SUPPLEMENT

Seaweed and probiotics is composed of seaweed and Duolac7S. Seaweed: 1. Form: brown granule 2. Dosage and frequency: 1 pack (3 g), 2 packs per day (30 min after morning, and evening meal) 3. Duration: 4 weeks of treatment period Duolac7S: 1. The probiotics, Duolac7S, consist of 7 bacteria. 2. Ingredients: Lactobacillus acidophilus, L. plantarum, L. rhamnosus, Bifidobacterium breve, B. lactis, B. longum, Streptococcus thermophilus. 3. Dosage and frequency: 1 capsule (5✕1,000,000,000 bacteria/capsule \[7✕100,000,000 viable cells/strain\]), 2 capsules per day (30 min after morning and evening meal) 4. Duration: 4 weeks of treatment period

Also known as: Seaweed and probiotics

Seaweed and Duolac7S

Seaweed and Duolac7S-P DIETARY_SUPPLEMENT

Seaweed and probiotics is composed of seaweed and Duolac7S-P(Placebo Duolac7S). Seaweed: 1. Form: brown granule 2. Dosage and frequency: 1 pack (3 g), 2 packs per day (30 min after morning, and evening meal) 3. Duration: 4 weeks of treatment period Duolac7S-P: Duolac7S placebo has the same form, color and flavor as experimental intervention (Duolac7S). The dosage, frequency and duration is also the same as experimental intervention (Duolac7S).

Also known as: Seaweed and placebo probiotics

Seaweed and Duolac7S-P

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 18 - 75, with a elementary-school diploma or higher, must be literate
• One who does not have any diseases or clinical symptoms related to digestive system
• One whose every question of KGSRS is under 3 points
• One who agree on not taking other therapies during the trial
• During the past 5 yrs, no history of organic lesion proven by colonoscopy
• One who agree on consent form

You may not qualify if:

• Patients who have abdominal operation in the past (exception: appendectomy, caesarean section, tubal ligation, laparoscopic cholecystectomy, hysterectomy and abdominal wall hernia repair)
• Patients who have history of serious diseases (cholangitis, pancreatitis, enteritis, ulcer, bleeding, cancer, etc.)
• Before participating clinical trial, one who took over-the-count medication affecting GI motility
• One who took antibiotics, herbal medicine or probiotics within 2 wks before participating the trial
• Pregnant woman
• One who disagree on the consent form

Sponsors & Collaborators

• Korea Institute of Planning & Evalution for Technology of Food, Agriculture, Forestry & Fisherie: lead

Study Sites (1)

Kyung Hee University Hospital at Gangdong

Seoul, Gangdong-gu, 134-727, South Korea

Location

Related Publications (2)

• Jeong JH, Jo YN, Kim HJ, Jin DE, Kim DO, Heo HJ. Black soybean extract protects against TMT-induced cognitive defects in mice. J Med Food. 2014 Jan;17(1):83-91. doi: 10.1089/jmf.2013.3023.

  PMID: 24456358 DERIVED

• Ko SJ, Kim J, Han G, Kim SK, Kim HG, Yeo I, Ryu B, Park JW. Laminaria japonica combined with probiotics improves intestinal microbiota: a randomized clinical trial. J Med Food. 2014 Jan;17(1):76-82. doi: 10.1089/jmf.2013.3054.

  PMID: 24456357 DERIVED

Related Links

• This is the URL of the site in which the clinical trial will be conducted.

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Jae-Woo Park, KMD, PhD

  Department of Internal Medicine, College of Oriental Medicine, Kyung Hee University, 1 Hoegi-dong, Dongdaemun-gu, Seoul 130-701, Republic of Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 25, 2012
• First Posted: July 27, 2012
• Study Start: May 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: September 24, 2013

Record last verified: 2013-09

Locations

KR (1)