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OpenTrials
Completed

NCT Number: NCT03287726

What is the Impact of Probiotics on Weight Loss Maintenance in Individuals With Obesity?

Weight loss maintenance is the biggest challenge in obesity management, with the majority of weight-reduced individuals experiencing weight regain. The intake of probiotics has been shown to help in weight loss, but its potential in maximizing weight loss maintenance remains unknown. Therefore, the main aim of this study is to investigate the impact of probiotic consumption on weight loss maintenance. Secondary aims are to investigate if the intake of probiotics influences gut microbiota, cardio-metabolic profile, appetite and inflammatory markers.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Olavs Hospital

Trondheim, Norway

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • class I or II obesity (30 kg/m2 < BMI > 40 kg/m2)
  • weight stable (<2 kg variation in weight within the last 3 months)
  • not currently dieting to lose weight
  • dietary intervention of 1000 kcal energy restriction for 8 weeks using a powder based low energy diet product, followed by 4 week weight stabilization phase (re-introduction of food)
  • women who are either post-menopausal, taking oral contraceptives or with a normal cycle (28 ± 2 days)

Exclusion criteria

  • consumption of probiotics 6 months before taking part in the study
  • pregnant
  • breast-feeding
  • drug or alcohol abuse within the last two years
  • currently taking medication known to affect appetite or induce weight loss
  • enrolled in another obesity treatment program
  • history of psychological disorders
  • having had bariatric surgery
  • metabolic diseases (such as hypo/hyperthyroidism and diabetes type 1 or 2)
  • eating disorders
  • lactose intolerance
  • gastrointestinal (particularly cholelithiasis), kidney, liver, lung, cardiovascular disease
  • malignancies

Treatment and study plan

Probiotics

Dietary Supplement

NYCOPRO, a multistrain probiotic (7 strains of Lactobacilli and Bifidobacteria) sold in the Norwegian pharmacies. 2 capsules/day (one with lunch and one with dinner). 2 text messages daily as a reminder. Follow up meeting at ObeCe (St. Olavs hospital) every month with a research nurse, for weighing, blood pressure measurement and collection of probiotics dose for the following month.

Placebo

Dietary Supplement

Placebo 2 capsules/day (one with lunch and one with dinner). 2 text messages daily as a reminder. Follow up meeting at ObeCe (St. Olavs hospital) every month with a research nurse, for weighing, blood pressure measurement and collection of probiotics dose for the following month.

Primary outcomes

  1. body composition

    Time frame: 9 months

    air displacement plethysmography (BodPod, COSMED, Italy)

Secondary outcomes

  1. appetite suppression

    Time frame: 9 months

    Online Visual Analogue Scale (VAS) for the measurement of subjective feelings of appetite (hunger, fullness, desire to eat, prospective consumption)

  2. body composition

    Time frame: 9 months

    Bioelectrical impedance analysis (BIA)

  3. resting metabolic rate

    Time frame: 9 months

    indirect calorimetry

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Norwegian University of Life Sciences
  • St. Olavs Hospital

Registry information

Official study title

Evaluation of the Potential Impact of Probiotics on Weight Loss Maintenance in Individuals With Obesity

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Sep 19, 2017
Registry last updated
Mar 4, 2021

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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