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Completed

NCT Number: NCT00880958

Effects of Supplement Containing Various Probiotics and Fermentation Products on Obesity

The purpose of this study is to determine the effect of supplement combined various probiotics and fermentation products on body mass index, body fat mass, abdominal circumference, visceral fat mass, intestinal flora, and serum biochemical parameters in overweight subjects.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hiroshima University

Hiroshima, 734-8551, Japan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy as based on medical history and physical examination
  • BMI between 25 and 30 kg/m2
  • Willing not to serve as blood donor during the study
  • Informed consent signed

Exclusion criteria

  • Food allergy
  • Female subjects who are pregnant or nursing a child
  • Participation in any clinical trial up to 90 days before Day 01 of this study
  • Renal or hepatic dysfunction
  • Heart disease
  • Under medication
  • Subjects who are taking functional food designed for weight loss or serum lipid reduction

Treatment and study plan

Mixture of various probiotics and fermentation products

Dietary Supplement

Placebo

Dietary Supplement

Primary outcomes

  1. Body mass index

    Time frame: 16 weeks

Secondary outcomes

  1. Body fat mass

    Time frame: Week -4, Week 0, Week 4, Week 12

  2. Abdominal circumference

    Time frame: Week -4, Week 0, Week 4, Week 12

  3. Visceral fat area by CT scan

    Time frame: Week 0, Week 12

  4. Intestinal flora

    Time frame: Week 0, Week 12

  5. Serum lipid profile

    Time frame: Week -4, Week 0, Week 4, Week 12

  6. Serum adiponectin and leptin levels

    Time frame: Week 0, Week 12

  7. Fasting serum glucose and HbA1c levels

    Time frame: Week -4, Week 0, Week 4, Week 12

Sponsors and collaborators

Lead sponsor

Hiroshima University

Other

Collaborators

  • Biostir, Inc.
  • MIONA Co., Ltd.

Registry information

Official study title

Effects of Supplement Containing Various Probiotics and Fermentation Products on Obesity: a Double-Blind, Randomized Controlled Trial

Important dates

Study start
2009
Study completion
2009
First posted
Apr 14, 2009
Registry last updated
Oct 29, 2009

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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