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

Mibelle

Status: Completed

Conditions: Weight Loss

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Santa herba

Study type: Interventional

Funder types: Industry

Identifiers

NCT03853603

BTS1235/18

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: Female

Ages: 25 to 60 years old

Volunteers: Accepts 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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Maltodextrin

Treatment:

Dietary Supplement: Placebo

Santa herba extract

Active Comparator group

Description:

Santa herba extract

Treatment:

Dietary Supplement: Santa herba