Targeting Obesity With the Probiotic Lactiplantibacillus Plantarum IMC 510 (PRO-Weight-Control Study)

NCT05358301 | Completed DMC

• 1 other identifier: PRO-Weight-Control
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

In recent decades, the prevalence of obesity has reached epidemic proportions, with the number of overweight or obese individuals continuing to increase worldwide. Advances in recent research have allowed a better characterization of the etiology of obesity, demonstrating the involvement of the gut microbiota. In fact, while signals from the brain influence gut function, the gut microbiota has been shown to modulate brain functions involved in the regulation of stress, depression and anxiety, which are closely linked to obesity. Oral administration of probiotics has been proposed as a valid way to modulate the gut ecosystem to promote weight reduction. Preliminary data showed that obese rats treated with probiotics containing the probiotic strain Lactiplantibacillus Plantarum IMC 510 exhibited significantly lower weight and food intake than untreated obese rats. Although exercise and diet are the first lines of intervention to be recommended, there are often failures or poor outcomes. There is currently increased interest in alternative and effective shorter-term, non-pharmacological approaches to weight control that involve the use of natural active ingredients. Thus, the aim of this intervention study is to investigate whether a probiotic supplementation with Lactiplantibacillus Plantarum IMC 510 could be beneficial for the weight reduction of people with obesity.

Conditions

Obesity

Keywords

obesity; probiotic; Lactiplantibacillus Plantarum; gut microbiota; clinical trial

Outcome Measures

Primary Outcomes (1)

• Body weight

  Changes of body weight from baseline assessed through a balance

  2 months

Secondary Outcomes (23)

• Fat mass

  2 months

• Fat-free mass

  2 months

• Total body water

  2 months

• White blood cells

  2 months

• Red blood cells

  2 months

Study Arms (2)

Probiotic

EXPERIMENTAL

Probiotic food supplement produced by SYNBIOTEC S.r.l.

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

Placebo food supplement.

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

Probiotic food supplement produced by SYNBIOTEC S.r.l. Each capsule of SYNBIO®slim contains the probiotic strain Lactiplantibacillus Plantarum IMC 510 at a concentration of 15 billion live cells (CFU/capsule). The assumption is of n°1 capsule/day, preferably at breakfast, for 3 months. The capsules can be opened and their content can be dispersed in a cold liquid or at intake temperature or in semi-solid food. Always store in original container or in a clean covered container, out of the reach of children. When stored in a dry, clean environment, out of direct sunlight, the product has a shelf-life of at least 24 months. Samples of probiotic supplement in closed and sealed boxes will be provided to subjects participating at the beginning of the study, in quantities sufficient for the entire duration of the study (90 capsules for 3 months).

Probiotic

Placebo DIETARY_SUPPLEMENT

N°1 capsule/day of placebo food supplement (i.e., capsules without added probiotics), with the same intake modalities as probiotic.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women 18-65 years of age
• Obesity (BMI \>30 kg/m2, class I, II, III) and overweight (BMI 25-29.9 kg/m2)
• Willingness to cooperate during the study and ability to follow guidelines
• Willingness to complete questionnaires and diaries associated with the study and to complete all clinical visits
• Willingness to discontinue functional foods and dietary supplements with probiotics, laxatives and body weight control substances
• Ability to provide informed consent

You may not qualify if:

• Continued use of probiotics in the two months prior to treatment
• Use of other treatments (medications or nutritional programs) that affect body weight, food intake and/or energy expenditure
• Postmenopausal women
• Pregnant or lactating
• Enrolled in another obesity treatment program

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Careggi: lead

Study Sites (1)

Unit of Clinical Nutrition, University Hospital of Careggi

Florence, 50134, Italy

Location

Related Publications (10)

• Albanese D, De Filippo C, Cavalieri D, Donati C. Explaining diversity in metagenomic datasets by phylogenetic-based feature weighting. PLoS Comput Biol. 2015 Mar 27;11(3):e1004186. doi: 10.1371/journal.pcbi.1004186. eCollection 2015 Mar.

  PMID: 25815895 BACKGROUND

• Borgeraas H, Johnson LK, Skattebu J, Hertel JK, Hjelmesaeth J. Effects of probiotics on body weight, body mass index, fat mass and fat percentage in subjects with overweight or obesity: a systematic review and meta-analysis of randomized controlled trials. Obes Rev. 2018 Feb;19(2):219-232. doi: 10.1111/obr.12626. Epub 2017 Oct 18.

  PMID: 29047207 BACKGROUND

• Chung HJ, Yu JG, Lee IA, Liu MJ, Shen YF, Sharma SP, Jamal MA, Yoo JH, Kim HJ, Hong ST. Intestinal removal of free fatty acids from hosts by Lactobacilli for the treatment of obesity. FEBS Open Bio. 2016 Jan 18;6(1):64-76. doi: 10.1002/2211-5463.12024. eCollection 2016 Jan.

  PMID: 27047743 BACKGROUND

• Dinan TG, Cryan JF. Melancholic microbes: a link between gut microbiota and depression? Neurogastroenterol Motil. 2013 Sep;25(9):713-9. doi: 10.1111/nmo.12198.

  PMID: 23910373 BACKGROUND

• Gomes AC, de Sousa RG, Botelho PB, Gomes TL, Prada PO, Mota JF. The additional effects of a probiotic mix on abdominal adiposity and antioxidant Status: A double-blind, randomized trial. Obesity (Silver Spring). 2017 Jan;25(1):30-38. doi: 10.1002/oby.21671.

  PMID: 28008750 BACKGROUND

• Segata N, Izard J, Waldron L, Gevers D, Miropolsky L, Garrett WS, Huttenhower C. Metagenomic biomarker discovery and explanation. Genome Biol. 2011 Jun 24;12(6):R60. doi: 10.1186/gb-2011-12-6-r60.

  PMID: 21702898 BACKGROUND

• Verdenelli MC, Ghelfi F, Silvi S, Orpianesi C, Cecchini C, Cresci A. Probiotic properties of Lactobacillus rhamnosus and Lactobacillus paracasei isolated from human faeces. Eur J Nutr. 2009 Sep;48(6):355-63. doi: 10.1007/s00394-009-0021-2. Epub 2009 Apr 14.

  PMID: 19365593 BACKGROUND

• John GK, Wang L, Nanavati J, Twose C, Singh R, Mullin G. Dietary Alteration of the Gut Microbiome and Its Impact on Weight and Fat Mass: A Systematic Review and Meta-Analysis. Genes (Basel). 2018 Mar 16;9(3):167. doi: 10.3390/genes9030167.

  PMID: 29547587 BACKGROUND

• Sanchez M, Darimont C, Panahi S, Drapeau V, Marette A, Taylor VH, Dore J, Tremblay A. Effects of a Diet-Based Weight-Reducing Program with Probiotic Supplementation on Satiety Efficiency, Eating Behaviour Traits, and Psychosocial Behaviours in Obese Individuals. Nutrients. 2017 Mar 15;9(3):284. doi: 10.3390/nu9030284.

  PMID: 28294985 BACKGROUND

• Sanders ME. Probiotics and microbiota composition. BMC Med. 2016 Jun 2;14(1):82. doi: 10.1186/s12916-016-0629-z.

  PMID: 27250499 BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

Probiotics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Francesco Sofi, Prof.

  Unit of Clinical Nutrition, University hospital of Careggi, Florence, italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: By keeping both the experimenters and the participants blind, bias is less likely to influence the results of the experiment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Nutrition

Model Details: Randomized double-blind parallel controlled trial

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: May 3, 2022
• Study Start: January 7, 2022
• Primary Completion: June 30, 2022
• Study Completion: October 31, 2022
• Last Updated: February 2, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)