A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial to Assess the Efficacy and Safety of 12 Weeks of Satiereal(R) Supplementation on Food Cravings and Preferences, Body Composition, Satiety and Appetite Regulatory Hormones, and Clinical Safety Markers in Overweight/Obese Individuals

A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial to Assess the Efficacy and Safety of 12 Weeks of Satiereal(R) Supplementation on Food Cravings and Preferences in Overweight/Obese Individuals

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000092897

Enrollment

Registered

2012-01-18

Start date

2012-07-30

Completion date

2015-04-23

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary purpose of the study is to assess the efficacy and safety of 12 Weeks supplementation of a novel extract of saffron stigma, Satiereal (Registered Trademark) on food cravings and preferences, body composition, satiety and appetite regulatory hormones, and clinical safety markers in overweight/obese individuals. We hypothesize that oral supplementation with Satiereal may reduce snacking and enhance satiety through its suggested mood-improving effect, and thus contribute to weight loss and/or maintenance.

Interventions

Satiereal is a single patented C sativus stigma extract (Inoreal Ltd, Plerin, France). Satiereal is notified and registered as food supplement in France by the National Trade and Fraud Authority (Direction Generale de la Concurrence, de la Consommation et de la Repression des Fraudes). 88.25 mg twice daily for 12 weeks. The supplement will come in a gelatin capsule

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

20 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

Healthy females with a body mass index (BMI) greater than 25 kg/m2 and less than 35 kg/m2.

Exclusion criteria

Exclusion criteria include recent pregnancy, history of cancer, diabetes (fasting blood glucose greater than 126mg/dL or hemoglobin A1c test greater than 6.5%), pathologic eating disorder, anxiety or depression, abnormal liver or kidney function, concomitant medication or psychotropic drugs or appetite suppressants, gastric surgery, or the use of any dietary supplement that might interfere with the results of the study.

Outcome results