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Effects of health food products on weight loss in Japanese volunteers whose obesity classification is 1 or 2 as defined by the Japan Society for the Study of Obesity

Effects of health food products on weight loss in Japanese volunteers whose obesity classification is 1 or 2 as defined by the Japan Society for the Study of Obesity - Effects of health food products on weight loss in Japanese obese volunteers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000028927
Enrollment
90
Registered
2017-09-05
Start date
2017-09-13
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity classification 1 and 2 as defined by the Japan Society for the Study of Obesity

Interventions

Subjects will consume one of the 4 test diets. Test diet A (low-carbohydrate, energy-restricted meal or snack
approx. 1400 kcal/day with approx. 25% of &quot
available carbohydrates&quot
[saccharides]) will be ingested 6 times/day for 8 weeks. Test diet B (moderately low-carbohydrate meal or snack
approx. 1400 kcal/day with approx. 40% of available carbohydrates) will be ingested 4 times/day for 8 weeks. Test diet C (low-carbohydrate, energy-restricted meal
approx. 250 kcal/meal with approx. 30% of available carbohydrates) will substitute one of 3 meals daily for 4 weeks. Test diet D (hummus 120 g
approx. 260-400 kcal/120 g with approx. 15% of available carbohydrates in average) will be ingested daily together with regular meals for 4 weeks.

Sponsors

InCROM Inc.
Lead Sponsor
InCROM Inc. InCROM Plus Inc.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Japanese adults who voluntarily give written informed consent; who wish to lose weight by ingesting health food products; whose BMI is >= 25.0 and < 35.0 when giving informed consent, i.e., obesity classification 1 or 2 as defined by the Japan Society for the Study of Obesity; and who are capable of recording body weight and other health-related data using the specified smartphone application

Exclusion criteria

Exclusion criteria: Diabetic patients History of previous or present illness that interferes with ethical conduct of the research as determined by the investigator, e.g., hepatic or renal disorder; cardiovascular, respiratory, endocrine, metabolic, nervous, or psychological disease (except hypertension and dyslipidemia) Known drug or food allergy History of previous or present drug or alcohol dependence

Design outcomes

Primary

MeasureTime frame
Changes in body weight and BMI from baseline (before start of test diets) to end of test diets and 8 week thereafter, and changes in body weight and BMI from end of test diets to 8 weeks thereafter

Secondary

MeasureTime frame
Changes over time in body weight, BMI, vital signs and clinical laboratory tests

Countries

Japan

Contacts

Public ContactHisayoshi Daito

Heishinkai Medical Group Incorporated, OCROM Clinic Director

hisayoshi.daito@heishinkai.com06-6330-8810

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026