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Completed

NCT Number: NCT03853603

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

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.

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Key information

Age range

25 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

BioTeSys GmbH

Esslingen am Neckar, 73728, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Santa herba

Dietary Supplement

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

Placebo

Dietary Supplement

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

Primary outcomes

  1. Body weight

    Time frame: day 85

    electronic scale

Secondary outcomes

  1. Body fat (%)

    Time frame: Day 85

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

  2. BCM/ECM index

    Time frame: Day 85

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

  3. Waist-hip ratio (WHR)

    Time frame: Day 85

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

  4. Sagittal abdominal diameter (SAD) [cm]

    Time frame: Day 85

    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.

  5. Concentration of lipid profile in serum

    Time frame: Day 85

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

  6. Concentration of Lipokin in plasma

    Time frame: Day 85

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

  7. Questionnaire about Appetite (AEBQ)

    Time frame: Day 85

    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

Sponsors and collaborators

Lead sponsor

Mibelle AG

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 25, 2019
Registry last updated
Aug 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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