Effects of 300mg Lactium® supplementation on acute and chronic stress levels in healthy volunteers

Not Applicable

Recruiting

Conditions: acute and chronic stress

Registration Number: DRKS00010817

Lead Sponsor: Ingredia SA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

20 - 60 years old;
pre-menopausal women have to be on hormonal contraception (for 3 months or more);

Exclusion Criteria

- Smoking more than 5 cigarettes per day;
- Known allergies to ingredients of the test substances;
- Known addiction to drugs and/or alcohol;
- Hyper- or hypotension (systolic > 140 or < 90, diastolic > 90 or < 60) (except for those whose blood pressure is stable using medication for more than 3 months);
- Known hyper- or hypothyroidism unless treated and under control (stable for more than 3 months);
- Has taken dietary supplements or homoeopathic remedies in the two weeks prior to the first visit;
- Is on a strikt diet or practices sport, extensively;
- Any other current/acute diseases besides minor medical conditions (e.g. seasonal allergies);
- Perceived pathologically anxious subjects;
- Subjects having previously participated in the TSST;
- Subjects working on nightshift;
- Pregnant or lactating females or females planning pregnancy within the next 3 months;
- Post-menopausal women using hormonal medication for less than 3 months;
- Employee of the sponsor or CRO.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of this study is to evaluate the efficacy of a daily intake of 300mg Lactium over a period of 4 weeks on subjectively perceived stress during an acute stressful situation as compared to a control product. Efficacy is defined as a lower increase in the Visual Analog Scale Stress of the test group in response to the Trier Social Stress Test as compared to the control group.

Secondary Outcome Measures