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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03287726

Enrollment

Registered

2017-09-19

Start date

2017-11-16

Completion date

2020-12-31

Last updated

2021-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Probiotics, Appetite Regulation, Gastrointestinal microbiome, Caloric Restriction, Body weight maintenance, Body composition

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.

Interventions

DIETARY_SUPPLEMENTprobiotics

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.

DIETARY_SUPPLEMENTplacebo

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
body composition	9 months	air displacement plethysmography (BodPod, COSMED, Italy)

Secondary

Measure	Time frame	Description
appetite suppression	9 months	Online Visual Analogue Scale (VAS) for the measurement of subjective feelings of appetite (hunger, fullness, desire to eat, prospective consumption)
body composition	9 months	Bioelectrical impedance analysis (BIA)
resting metabolic rate	9 months	indirect calorimetry

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026