Back to results

Clinical Study to Investigate the Effects of a Food Supplement Santa Herba Extract on Weight Loss in Overweight Women

Primary Purpose

Weight Loss

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Santa herba

Placebo

About this trial

This is an interventional basic science trial for Weight Loss focused on measuring lipid profile, 12,13-diHOME

Eligibility Criteria

25 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Subject is able and willing to follow the study protocol procedures to sign the Informed Consent Form prior to screening evaluations
Overweight and obese women with BMI 25 - 35 kg/m2 (limits included)
Age: 25 - 60 years
Subject is in good physical and mental health as established by medical history, physical examination, electrocardiogram, vital signs, results of biochemistry, haematology

Exclusion Criteria:

Relevant history or presence of any medical disorder potentially interfering with this study (heavy depression, diabetes, active cancer, severe liver disease, heavy cardiovascular diseases (e.g. stroke, heart attack))
Chronic intake of medication/dietary supplements with impact on body weight or body composition or lipid modifying products (e.g. protein shakes, statins, omega-3 fatty acids, etc.) 2 months prior to screening or during the study; stable doses of e.g. hypertensive therapy and thyroid gland hormones are acceptable.
Change in hormonal contraceptive during or at least 3 months before the study
Consumption of any dietary supplement / fortified food (with exception of vitamin D and mineral supplements e.g. Ca, Mg)
Low body fat mass measured at screening with BIA ( bioelectrical impedance analysis ) (Cut off-value: <36% body fat).
Weight loss intervention or recent body weight change > 4.5 kg during last 3 months
Diet high in vegetables and fruits ≥ 5 portions per day
Vegan lifestyle
Smoker > 10 cigarettes / day
Gastrointestinal diseases/conditions (colitis ulcerosa, Crohn's disease, peptic ulcers, celiac disease)

Sites / Locations

BioTeSys GmbH

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Santa herba extract

Arm Description

Maltodextrin

Santa herba extract

Outcomes

Primary Outcome Measures

Body weight

electronic scale

Secondary Outcome Measures

Body fat (%)

Body fat mass in kilograms (kg) and weight in kilograms (kg) will be combined to report Percent body fat in (kg/kg)*100 (%)

BCM/ECM index

Body cell mass (BCM) in kg and extracellular mass (ECM) in kg will be combined to report BCM/ECM index

Waist-hip ratio (WHR)

Waist circumference in centimetre (cm) and hip circumference in centimetre (cm) will be combined to report WHR in cm/cm

Sagittal abdominal diameter (SAD) [cm]

Sagittal abdominal diameter (SAD) or "supine abdominal height" is a simple anthropometric measure shown to be a marker of insulin resistance. SAD is measured after normal expiration at the level of iliac crest while in the supine position with bent knees on a firm examination table and without clothes in the measurement area. The measurement is performed with the Holtain-Kahn abdominal caliper.

Concentration of lipid profile in serum

Concentration of Cholesterol [mg/dL], triglycerides [mg/dL], LDL-cholesterol [mg/dL], HDL-cholesterol [mg/dL]

Concentration of Lipokin in plasma

12,13-diHOME (12,13-Dihydroxyoctadec-9-enoic acid) [pmol/mL]

Questionnaire about Appetite (AEBQ)

The Adult Eating Behavior Questionnaire (Hunot et al. 2016) about perception of hunger and satiety including ravenousness appetite and snacking habits will be performed throughout the study. AEBQ is a questionnaire measuring 8 different appetitive traits. Enjoyment of food Emotional over-eating Emotional under-eating Food fussiness Food responsiveness Slowness in eating Hunger Satiety responsiveness Scale: 5-point Likert scale: Strongly disagree =1 Disagree =2 Neitheragree nor disagree =3 Agree =4 Strongly agree =5

Full Information

NCT ID

NCT03853603

First Posted

February 12, 2019

Last Updated

August 13, 2019

Sponsor

Mibelle AG

1. Study Identification

Unique Protocol Identification Number

NCT03853603

Brief Title

Clinical Study to Investigate the Effects of a Food Supplement Santa Herba Extract on Weight Loss in Overweight Women

Official Title

Clinical Study to Investigate the Effects of a Food Supplement With Santa Herba Extract on Weight Loss and Modulation of Appetite-related Biomarkers in Overweight Women - a Randomized, Placebo-controlled Parallel Study

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

February 15, 2019 (Actual)

Primary Completion Date

August 12, 2019 (Actual)

Study Completion Date

August 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mibelle AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Aim of the study is to investigate the effect of a 12-week supplementation of Santa Herba Extract on body weight in overweight and obese subjects. Additionally appetite related marker as well as marker of white adipose tissue browning will be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Weight Loss

Keywords

lipid profile, 12,13-diHOME

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Maltodextrin

Arm Title

Santa herba extract

Arm Type

Active Comparator

Arm Description

Santa herba extract

Intervention Type

Dietary Supplement

Intervention Name(s)

Santa herba

Intervention Description

Santa herba dry extract; 400 mg/day. 2 capsules/day; 1 capsule twice daily with the main meals (lunch and dinner)

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

Maltodextrin; 400 mg/day. 2 capsules/day; 1 capsule twice daily with the main meals (lunch and dinner)

Primary Outcome Measure Information:

Title

Body weight

Description

electronic scale

Time Frame

day 85

Secondary Outcome Measure Information:

Title

Body fat (%)

Description

Body fat mass in kilograms (kg) and weight in kilograms (kg) will be combined to report Percent body fat in (kg/kg)*100 (%)

Time Frame

Day 85

Title

BCM/ECM index

Description

Body cell mass (BCM) in kg and extracellular mass (ECM) in kg will be combined to report BCM/ECM index

Time Frame

Day 85

Title

Waist-hip ratio (WHR)

Description

Waist circumference in centimetre (cm) and hip circumference in centimetre (cm) will be combined to report WHR in cm/cm

Time Frame

Day 85

Title

Sagittal abdominal diameter (SAD) [cm]

Description

Time Frame

Day 85

Title

Concentration of lipid profile in serum

Description

Concentration of Cholesterol [mg/dL], triglycerides [mg/dL], LDL-cholesterol [mg/dL], HDL-cholesterol [mg/dL]

Time Frame

Day 85

Title

Concentration of Lipokin in plasma

Description

12,13-diHOME (12,13-Dihydroxyoctadec-9-enoic acid) [pmol/mL]

Time Frame

Day 85

Title

Questionnaire about Appetite (AEBQ)

Description

Time Frame

Day 85

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject is able and willing to follow the study protocol procedures to sign the Informed Consent Form prior to screening evaluations Overweight and obese women with BMI 25 - 35 kg/m2 (limits included) Age: 25 - 60 years Subject is in good physical and mental health as established by medical history, physical examination, electrocardiogram, vital signs, results of biochemistry, haematology Exclusion Criteria: Relevant history or presence of any medical disorder potentially interfering with this study (heavy depression, diabetes, active cancer, severe liver disease, heavy cardiovascular diseases (e.g. stroke, heart attack)) Chronic intake of medication/dietary supplements with impact on body weight or body composition or lipid modifying products (e.g. protein shakes, statins, omega-3 fatty acids, etc.) 2 months prior to screening or during the study; stable doses of e.g. hypertensive therapy and thyroid gland hormones are acceptable. Change in hormonal contraceptive during or at least 3 months before the study Consumption of any dietary supplement / fortified food (with exception of vitamin D and mineral supplements e.g. Ca, Mg) Low body fat mass measured at screening with BIA ( bioelectrical impedance analysis ) (Cut off-value: <36% body fat). Weight loss intervention or recent body weight change > 4.5 kg during last 3 months Diet high in vegetables and fruits ≥ 5 portions per day Vegan lifestyle Smoker > 10 cigarettes / day Gastrointestinal diseases/conditions (colitis ulcerosa, Crohn's disease, peptic ulcers, celiac disease)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel Menzel, MD

Organizational Affiliation

BioTeSys GmbH

Official's Role

Principal Investigator

Facility Information:

Facility Name

BioTeSys GmbH

City

Esslingen

ZIP/Postal Code

73728

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34255555

Citation

Modinger Y, Schon C, Wilhelm M, Pickel C, Grothe T. A Food Supplement with Antioxidative Santa Herba Extract Modulates Energy Metabolism and Contributes to Weight Management. J Med Food. 2021 Nov;24(11):1235-1242. doi: 10.1089/jmf.2021.0016. Epub 2021 Jul 13.

Results Reference

derived

Learn more about this trial

Clinical Study to Investigate the Effects of a Food Supplement Santa Herba Extract on Weight Loss in Overweight Women

We'll reach out to this number within 24 hrs