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Completed

NCT Number: NCT01931930

Effect of Perilla Extract on Improvement on Gastrointestinal Discomfort

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).

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Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BioTeSys GmbH

Esslingen am Neckar, 73728, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Perilla extract

Dietary Supplement

Maltodextrin

Dietary Supplement

Primary outcomes

  1. daily gastrointestinal symptoms

    Time frame: was assessed daily during 4 week intervention

    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.

Secondary outcomes

  1. validated questionnaires

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

    Three validated questionnaires were used. Two of them were specially designed to evaluate gastrointestinal symptoms and quality of life of people with constipation. The third questionnaire was a validated questionnaire to report stress levels and related changes of stress levels.

    • Patient assessment of constipation symptoms (PAC SYM)
    • Patents assessment of constipation quality of life (PAC QOL)
    • Perceived stress questionnaire (PSQ20)
  2. stool consistency

    Time frame: reported at days with stool during 4 week intervention

    The stool consistency was rated referring to the Bristol stool scale. A scale indicated with pictures how the stool consistency can be rated.

  3. Adverse events

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

    All adverse events which might be linked to the study product were reported. As the tested study product is a food product being safe for consumption as food no specific parameter to define safety were defined.

  4. Stool frequency

    Time frame: reported at days with stool during 4 week intervention

    The stool frequency was reported on each day with bowel movement.

Sponsors and collaborators

Lead sponsor

Amino Up Chemicals Co., Ltd.

Industry

Registry information

Official study title

Effect of Perilla Extract on Improvement of Intestinal Discomfort and Bowel Function in Healthy Volunteers With Gastrointestinal Discomfort

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Aug 30, 2013
Registry last updated
Aug 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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