Weight Regain After Consumption of Food Supplement and In... | NCT03554525

Studies
Weight Regain After Consumption of Food Supplement and Interventional Diet Program

NCT03554525

Sponsor

Instituto de Investigación Hospital Universitario La Paz

Status

Completed

Last Update Posted

Apr 17, 2019Actual

Enrollment

120Actual

Phase

Phase 3

Conditions

Obesity
Overweight
Weight Loss
Body Weight Changes
Weight Change, Body

Interventions

Fat-binder damm
Placebo

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2017Actual

Primary Completion Date

Dec 1, 2018Actual

Completion Date

Dec 1, 2018Actual

First Submitted Date

Apr 6, 2018

First Submission Date that Met QC Criteria

May 31, 2018

First Posted Date

Jun 13, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2019

Last Update Posted Date

Apr 17, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Effect of the dietary supplement (FAT-BINDER DAMM) on weight regain after 9 months of control weight program

Detailed Description

60 participants will consume experimental product every day 3 sticks of the dietary supplement (1.4 grams/stick) during 12 months: 2 sticks should be consumed before lunch and 1 stick before dinner. During the 12 first weeks, each volunteer will be included on a low weight program (PPP) with an individual hypocaloric diet planning and regular physical adapted activity (PPP period). When PPP period is over, volunteers will continue consuming the product for 9 months more (Post-PPP period).
60 participants will consume everyday 3 placebo sticks (1.4 grams/stick) during 12 months: 2 sticks should be consumed before lunch and 1 stick before dinner. During the first 12 weeks, each volunteer will be included on a low weight program (PPP) with an individual hypocaloric diet planning and regular physical adapted activity (PPP period ). When PPP period is over, volunteers will continue consuming the product for 9 months more.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental product : FAT-BINDER DAMM	Experimental	3 sticks of the dietary supplement (1.4 grams/stick) during 12 months: 2 sticks should be consumed before lunch and 1 stick before dinner.	Dietary Supplement: Fat-binder damm
Control product : PLACEBO	Placebo Comparator	3 sticks of the dietary supplement (1.4grams/stick) during 12 months: 2 sticks should be consumed before lunch and 1 stick before dinner.	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fat-binder damm	Dietary Supplement	3 sticks every day during 12 months	Experimental product : FAT-BINDER DAMM

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Weight Regain	Change from baseline in kilograms	12 months

Secondary Outcomes

Measure	Description	Time Frame
Body Mass Index (weight/height^2)	Change from baseline in kg/m^2	12 months
Fat mass percentage	Change from baseline in percentage

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men and women ranging from 18 to 65 years old.
BMI ≥27 and <40 kg/m2. Overweight type II, obesity type I and II
Social or familiar environment that prevents from accomplishing the dietary treatment.
Willingness to follow a balanced hypocaloric diet in order to lose weight and perform regular physical adapted activity.
Adequate cultural level and understanding of the clinical trial.
Signed informed consent.

Exclusion Criteria:

Individuals diagnosed with Diabetes Mellitus type I.
Individuals diagnosed with Diabetes Mellitus type II on pharmacological treatment.
Individuals with dyslipidemia on pharmacological treatment.
Individuals with hypertension on pharmacological treatment uncontrolled.
Individuals allergic to yeast.
Individuals with chronic diseases (hepatic, kidney…).
Individuals who have participated in the last 6 months in a program or clinical trial to lose weight.
Individuals receiving at least the preceding 2 months a pharmacological treatment that modifies the lipid profile (for example, statins, fibrates, diuretics, corticosteroids, ADOs).
Pregnant or breastfeeding women.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carmen Gómez Candela, PhD, MS	Hospital Universitario La Paz	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute for Health Research IdiPAZ		Madrid		28046	Spain

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D050177	Overweight
D015431	Weight Loss
D001836	Body Weight Changes

Ancestor Terms

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

Browse Leaves

Not provided

Browse Branches

Not provided