NCT03853603

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

February 15, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 25, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2019

Completed
Last Updated

August 14, 2019

Status Verified

August 1, 2019

Enrollment Period

6 months

First QC Date

February 12, 2019

Last Update Submit

August 13, 2019

Conditions

Weight Loss

Keywords

lipid profile12,13-diHOME

Outcome Measures

Primary Outcomes (1)

  • Body weight

    electronic scale

    day 85

Secondary Outcomes (7)

  • Body fat (%)

    Day 85

  • BCM/ECM index

    Day 85

  • Waist-hip ratio (WHR)

    Day 85

  • Sagittal abdominal diameter (SAD) [cm]

    Day 85

  • Concentration of lipid profile in serum

    Day 85

  • +2 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Maltodextrin

Dietary Supplement: Placebo

Santa herba extract

ACTIVE COMPARATOR

Santa herba extract

Dietary Supplement: Santa herba

Interventions

Santa herbaDIETARY_SUPPLEMENT

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

Santa herba extract
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age25 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BioTeSys GmbH

Esslingen am Neckar, 73728, Germany

Location

Related Publications (1)

  • 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.

    PMID: 34255555DERIVED

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Daniel Menzel, MD

    BioTeSys GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2019

First Posted

February 25, 2019

Study Start

February 15, 2019

Primary Completion

August 12, 2019

Study Completion

August 12, 2019

Last Updated

August 14, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)