Interest in the Medium Term of an Infrared Reflexotherapy on Overweight or Class I Obese People (REFLEX-IR)

Pasteur Institute of Lille (IPL)

Status: Terminated

Conditions: Assess the Effect of an IR Reflexotherapy on Overweight and Class I Obese People

Treatments: Device: IR Reflexotherapy; Behavioral: Dietary care

Study type: Interventional

Funder types: Other

Identifiers

NCT02000037

2013-A00800-45

Details and patient eligibility

About

The study aim is to Assess the Effect of an IR Reflexotherapy on Overweight and Class I Obese People.

Enrollment: 87 patients

Sex: All

Ages: 30 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• BMI between 27 and 35 kg/m2 (included),
• Aged 30 to 60 years old (included),
• Stable weight: no variation of 3 kg in the las 3 months,
• Signed the consent form,
• Able to follow the study,
• Health insured.

Exclusion criteria

• History of coronary disease (in the last 6 months),
• Progressive illness at the time of the study (cancer, neurodegenerative disease...),
• Diabetics (treated or not),
• Fasting blood total cholesterol equal or over 2.5 g/L (treated or not),
• Fasting blood triglycerides equal or over 2.0 g/L (treated or not),
• Fasting blood glucose equal or over 1.26 g/L,
• Peripheral neuropathy (polyneuritis, diabetic neuropathy) or central neuropathy (hemiplegia),
• Infectious cutaneous condition or allergies (to the contact point of the device),
• History of stroke,
• Severe heart disease,
• Epilepsy,
• Reduced motility,
• Diagnosed eating disorder,
• Followed a diet in the last 90 days in order to lose weight,
• Took weight loss assistance drug (Orlistat) in the last month or is likely to take one during the study,
• Psychiatric disorder incompatible with the study,
• Mental illness,
• Neurological disorder,
• Chronic somatic disease,
• Addiction or nicotine withdrawal,
• Under psychoactive drug ,
• Alcool consumption over 3 glasses a day,
• Pregnant or breastfeeding women,
• Women that are likely to get pregnant during the study,
• Is unable to understand or follow the protocol
• Is deprived of liberty
• Is under judicial protection

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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87 participants in 3 patient groups

Dietary care

Active Comparator group

Description:

Treatment is composed of a dietary care (with advices on physical activity) given by a professional (dietician of the Nutrition Department of the Institut Pasteur de Lille).

Treatment:

Behavioral: Dietary care

IR reflexotherapy + dietary care

Experimental group

Description:

Treatment is composed of : * IR reflexotherapy sessions given by a trained professional ; * dietary care (with advices on physical activity) given by a professional (dietician of the Nutrition Department of the Institut Pasteur de Lille).

Treatment:

Device: IR Reflexotherapy

Behavioral: Dietary care

IR Reflexotherapy

Experimental group

Description:

Treatment is composed of IR reflexotherapy sessions given by a trained professional.

Treatment:

Device: IR Reflexotherapy