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

NCT ID: NCT03287726

Last Updated: 2021-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-16

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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probiotics

Group Type EXPERIMENTAL

probiotics

Intervention Type 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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type 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.

Interventions

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probiotics

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.

Intervention Type DIETARY_SUPPLEMENT

placebo

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Olavs Hospital

OTHER

Sponsor Role collaborator

Norwegian University of Life Sciences

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Torstein Baade Rø, phd prof

Role: STUDY_CHAIR

Norwegian University of Science and Technology

Locations

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St Olavs Hospital

Trondheim, , Norway

Site Status

Countries

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Norway

References

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Martins C, Roekenes J, Salamati S, Gower BA, Hunter GR. Metabolic adaptation is an illusion, only present when participants are in negative energy balance. Am J Clin Nutr. 2020 Nov 11;112(5):1212-1218. doi: 10.1093/ajcn/nqaa220.

Reference Type RESULT
PMID: 32844188 (View on PubMed)

Other Identifiers

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2016/1297-10

Identifier Type: -

Identifier Source: org_study_id

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