NCT03287726

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 19, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

November 16, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

March 4, 2021

Status Verified

March 1, 2021

Enrollment Period

3.1 years

First QC Date

September 14, 2017

Last Update Submit

March 3, 2021

Conditions

Obesity

Keywords

ProbioticsAppetite RegulationGastrointestinal microbiomeCaloric RestrictionBody weight maintenanceBody composition

Outcome Measures

Primary Outcomes (1)

  • body composition

    air displacement plethysmography (BodPod, COSMED, Italy)

    9 months

Secondary Outcomes (3)

  • appetite suppression

    9 months

  • body composition

    9 months

  • resting metabolic rate

    9 months

Study Arms (2)

probiotics

EXPERIMENTAL
Dietary Supplement: probiotics

placebo

PLACEBO COMPARATOR
Dietary Supplement: placebo

Interventions

probioticsDIETARY_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.

probiotics
placeboDIETARY_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.

placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Olavs Hospital

Trondheim, Norway

Location

Related Publications (1)

  • 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.

    PMID: 32844188RESULT

MeSH Terms

Conditions

Obesity

Interventions

Probiotics

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Torstein Baade Rø, phd prof

    Norwegian University of Science and Technology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2017

First Posted

September 19, 2017

Study Start

November 16, 2017

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

March 4, 2021

Record last verified: 2021-03

Locations

NO(1)