NCT01931930

Brief Summary

In the current study the effects of proprietary Perilla frutescens leaf extract in comparison to Maltodextrin, a fully digestible carbohydrate (placebo control), on gastrointestinal discomfort and bowel function were investigated. The study was performed double-blind and placebo-controlled with a 4 week intervention period. Study products were taken two times daily (each one capsule before breakfast and dinner).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 30, 2013

Completed
Last Updated

August 30, 2013

Status Verified

August 1, 2013

Enrollment Period

4 months

First QC Date

August 23, 2013

Last Update Submit

August 29, 2013

Conditions

Abdominal Pain/ DiscomfortSlightly Constipation

Keywords

Gastrointestinal discomfortPerilla frutescensbloatingabdominal discomforthuman studyhealthy subjects

Outcome Measures

Primary Outcomes (1)

  • daily gastrointestinal symptoms

    The following gastrointestinal were rated and reported by the study participants on a daily based. Bloating, rumbling, feeling of fullness, passage of gas, abdominal discomfort (pain and cramps). The rating was done based on a number scale. 0 not at all and 4 extremely.

    was assessed daily during 4 week intervention

Secondary Outcomes (4)

  • validated questionnaires

    assessed at visit 1 (before) and at visit 2 (after 4 week intervention)

  • stool consistency

    reported at days with stool during 4 week intervention

  • Adverse events

    assessed at visit 1 (before) and at visit 2 (after 4 week intervention)

  • Stool frequency

    reported at days with stool during 4 week intervention

Study Arms (2)

Perilla extract

EXPERIMENTAL

Experimental arm: Perilla extract

Dietary Supplement: Perilla extract

Maltodextrin

PLACEBO COMPARATOR

Placebo arm: Maltodextrin

Dietary Supplement: Maltodextrin

Interventions

Perilla extractDIETARY_SUPPLEMENT
Perilla extract
MaltodextrinDIETARY_SUPPLEMENT
Maltodextrin

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers without clinical diagnosed diseases with relevant effect on the gastrointestinal system or on visceral motility.
  • BMI: 19-30 kg/m2
  • Reduced bowel movements defined as an average of \>1 and ≤ 3.5 stools per week for at least the previous 6 months
  • Gastrointestinal symptoms of at least 5 points
  • Male or female
  • Age ≥ 30 and ≤ 70 years
  • Nonsmoker
  • Written consent to participate in the study
  • Able and willing to follow the study protocol procedures

You may not qualify if:

  • Subject under prescription for medication for digestive symptoms such as anti-spasmodic, laxatives and anti-diarrheic drugs or other digestive auxiliaries
  • Relevant history, presence of any medical disorder or intake of medication / dietary supplements, potentially interfering with this trial at screening
  • Subjects with stool frequency of ≤ 1 stool every 7 days or \> 3,5 stools per week
  • Subjects not willing to avoid pre- and probiotics for the duration of the study
  • Intake of antibiotics in the last 4 weeks and laxatives in the last 2 weeks
  • Change of dietary habits within the 4 weeks prior to screening (for instance start of a diet high in fibers)
  • Pregnant subject or subject planning to become pregnant during the study; breast-feeding subject.
  • Subjects with history of drug, alcohol or other substances abuse, or other factors limiting their ability to co-operate during the study.
  • Participants anticipating a change in their lifestyle or physical activity levels since this may also influence the results.
  • Known food intolerance or allergy.
  • Subject involved in any clinical or food study within the preceding month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BioTeSys GmbH

Esslingen am Neckar, 73728, Germany

Location

Related Publications (1)

  • Buchwald-Werner S, Fujii H, Reule C, Schoen C. Perilla extract improves gastrointestinal discomfort in a randomized placebo controlled double blind human pilot study. BMC Complement Altern Med. 2014 May 27;14:173. doi: 10.1186/1472-6882-14-173.

    PMID: 24885816DERIVED

MeSH Terms

Interventions

maltodextrin

Study Officials

  • Daniel Menzel, PhD

    BioTeSys GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2013

First Posted

August 30, 2013

Study Start

July 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

August 30, 2013

Record last verified: 2013-08

Locations

DE(1)