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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03287726
• Other study ID #: 2016/1297-10
• Status: Completed
• Phase: N/A
• Start date: November 16, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2021
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Dietary Supplement:
• 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.
• 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.

Locations

Country	Name	City	State
Norway	St Olavs Hospital	Trondheim

Sponsors (3)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Norwegian University of Life Sciences, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	body composition	air displacement plethysmography (BodPod, COSMED, Italy)	9 months
Secondary	appetite suppression	Online Visual Analogue Scale (VAS) for the measurement of subjective feelings of appetite (hunger, fullness, desire to eat, prospective consumption)	9 months
Secondary	body composition	Bioelectrical impedance analysis (BIA)	9 months
Secondary	resting metabolic rate	indirect calorimetry	9 months