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Completed

NCT Number: NCT00826761

ProSat - Effect of Probiotics on Satiety

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.

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Key information

Conditions

Obesity Appetite Regulation Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Human Nutrition

Frederiksberg, Denmark

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Probiotic

Dietary Supplement

One capsule per meal test (high dose or low dose)

Placebo

Dietary Supplement

1 capsuel every morning

Primary outcomes

  1. Glucose; Insulin; GLP-1; CCK; PYY; grehlin; PP; amylin; LPS; TNF-alfa; hsCRP; fibrinogen

    Time frame: 2013

Secondary outcomes

  1. Subjective appetite measurements; Spontaneous food intake

    Time frame: 2012

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Novonesis

Registry information

Official study title

Probiotics and Satiety - Acute Effects and Persistence of Acute Effects

Acronym: ProSat

Important dates

Study start
2009
Primary completion
2009
First posted
Jan 22, 2009
Registry last updated
Jun 15, 2012

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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