ProSat - Effect of Probiotics on Satiety

University of Copenhagen

Status: Completed

Conditions: Obesity; Appetite Regulation

Treatments: Dietary Supplement: placebo; Dietary Supplement: probiotic

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00826761

B257

Details and patient eligibility

About

The aim of the ProSat study is to examine the effects of a probiotic capsule containing one of two doses (low and high dose) of Lb. Casei on subjective appetite sensation, ad libitum energy intake, and appetite hormone response in a single meal test and to determine whether the acute effects persist after daily supplementation of the probiotic capsule.

Enrollment: 22 patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy men and women
• Normal to slight overweight (BMI: 22-28 kg/m2)
• 20-45 years of age

Exclusion criteria

• Smoking
• Daily medicine use (oral contraceptives excluded)
• Use of pre- and probiotic supplements and foods
• Blood donation 3 months prior to the study
• Hb<8mmol/l
• Chronic illnesses such as hyperlipidemia, diabetes inflammatory diseases
• Pregnancy or breastfeeding
• Elite athletes (>10 hours hard exercise/week)
• Vegetarians

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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22 participants in 3 patient groups, including a placebo group

1

Active Comparator group

Description:

High dose Lb. casei

Treatment:

Dietary Supplement: probiotic

2

Active Comparator group

Description:

Low dose Lb. Casei

Treatment:

Dietary Supplement: probiotic

3

Placebo Comparator group

Treatment:

Dietary Supplement: placebo