BEFORE Study, Efficacy of Refigura

NCT03557424 | Completed Phase 4

• 1 other identifier: BEFORE-Study
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

The BEFORE study ((B) EFficacy Of REfigura) is designed to demonstrate the efficacy of REFIGURA®. It is a double-blind, randomized, monocentric study.

Conditions

Overweight and Obesity; Weight Loss; Efficacy, Self

Keywords

Polyglucosamine; Glucomannan; Weight reduction; Weight loss; without change in lifestyle

Outcome Measures

Primary Outcomes (1)

• Changes in Bodyweight

  Changes in bodyweight during the study (weight reduction in kg). Comparison of the values obtained on day1 with results from day 65.

  Every two weeks (Start, 2 weeks, 4 weeks, 6 weeks, 8 Weeks)

Secondary Outcomes (3)

• Changes in BMI

  Every two weeks (Start, 2 weeks, 4 weeks, 6 weeks, 8 Weeks)

• Safety: occurence of adverse events

  Every week (from week 1 to week 10)

• Changes in blood pressure

  Every two weeks (Start, 2 weeks, 4 weeks, 6 weeks, 8 Weeks)

Study Arms (3)

Polyglucosamine Glucomannan normal dose

EXPERIMENTAL

Patients received the single dose Polyglucosamine und Glucomannan (0,5 g resp. 1 g per Stick) three times per day over 65 days. The drug is administered as a powder which is dissolved in water. The solution is taken orally.

Drug: Polyglucosamine Glucomannan normal dose (Verum)

Polyglucosamine Glucomannan high dose

EXPERIMENTAL

Patients received the higher dose of Polyglucosamine und Glucomannan (1 g resp. 1,34 g per Stick) three times per day over 65 days. The drug is administered as a powder which is dissolved in water. The solution is taken orally.

Drug: Polyglucosamine Glucomannan high dose (Verum)

Placebo

PLACEBO COMPARATOR

Patients received Placebo three times per day over 65 days. The Placebo is administered according to the respective Intervention (Drug: Placebo Comparator: Placebo) as a powder which is dissolved in water. The solution is taken orally.

Drug: Placebo Comparator: Placebo

Interventions

Polyglucosamine Glucomannan normal dose (Verum) DRUG

Patients received Verum three times a day for 65 days. The patients had to dissolve the powder included in one sachet in 250 ml water and drink the solution 15 minutes before each meal. It was recorded whether the patients changed their Lifestyle (their dietary habits and doing sports) during the study.

Also known as: Polyglucosamine Glucomannan normal dose

Polyglucosamine Glucomannan normal dose

Polyglucosamine Glucomannan high dose (Verum) DRUG

Patients received Verum 2 three times a day for 65 days. The patients had to dissolve the powder included in one sachet in 250 ml water and drink the solution 15 minutes before each meal. It was recorded whether the patients changed their Lifestyle (their dietary habits and doing sports) during the study.

Also known as: Polyglucosamine Glucomannan high dose

Polyglucosamine Glucomannan high dose

Placebo Comparator: Placebo DRUG

Patients received Placebo three times a day for 65 days. The patients had to dissolve the powder included in one sachet in 250 ml water and drink the solution 15 minutes before each meal. It was recorded whether the patients changed their Lifestyle (their dietary habits and doing sports) during the study.

Placebo

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 20-50 years
• Body mass index (BMI) ≥ 30 kg/m² or
• BMI between 25 and ˂ 30 kg/m² and simultaneous existence of at least one of the following factors:
• Overweight-related health disorder (e.g. Hypertension, type 2 Diabetes m.)
• Abdominal Obesity
• A disease aggravated by obesity
• High psychosocial pressure of suffering

You may not qualify if:

• Pregnancy (examination with the help of a pregnancy test using urine Lab Test at V2) and lactation
• Alcohol, drugs and drug abuse
• Limited compliance (pre-questionnaire examination)
• History of malignant tumors
• (chronic) Inflammatory diseases of the gastrointestinal tract
• Gastroparesis (stomach paralysis) in the anamnesis
• Signs of an intestinal closure (arising or existing mechanical or paralytic Ileus) in the anamnesis
• Gastric bridging surgery or gastric reduction
• Hypersensitivity or allergy to the ingredients
• Untreated or inadequately treated hypertension
• Diabetes mellitus (examination with the help of a urine tests)
• Treatment with diuretics or insulin
• Cortisone, which has a systemic effect
• Smokers who want to start weaning during the trial
• Untreated or insufficiently treated thyriodale disorders (if the patient is stable in the opinion of the physician, he may participate in the study)

Sponsors & Collaborators

• Heilpflanzenwohl AG: lead

Study Sites (1)

MIT Gesundheit GmbH

Kleve, North Rhine-Westphalia, 47533, Germany

Location

MeSH Terms

Conditions

Overweight; Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: double-blind, randomized
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Three armed, parallel, double blind, Placebo-controlled, interventional study

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 15, 2018
• Study Start: April 26, 2017
• Primary Completion: April 16, 2018
• Study Completion: April 16, 2018
• Last Updated: June 15, 2018

Record last verified: 2018-06

Locations

DE (1)