Effect of Omega-3 and Probiotic Dietary Supplements on Elevated High Sensitivity C-reactive Protein (Hs-CRP) as a Marker of Low-grade Inflammation

NCT04126330 | Completed

• 1 other identifier: Provita19
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

Study objectives: Immunity, Inflammation, and Brain Function To determine the effect of supplements with probiotics, Omega-3 and Vitamin D on the inflammatory marker highly sensitive CRP (primary outcome), markers of inflammation (secondary outcome), and gastrointestinal barrier function (secondary outcome) in elderly and obese cohorts that exhibit elevated inflammation at baseline. Mobility To determine the effect of supplements with probiotics, Omega-3 and Vitamin D on joints, bones, and muscles by means of the WOMAC questionnaire, sit/stand test (muscle function) and CTX-I (cartilage degradation) as secondary endpoints in elderly and obese cohorts that exhibit elevated inflammation at baseline.

Conditions

Inflammation

Outcome Measures

Primary Outcomes (1)

• hs-CRP

  Decrease in overall body inflammation measured by at least 15% reduction in hs-CRP levels in blood

  baseline, 4 weeks (mid-study), 8 weeks (study end)

Study Arms (4)

Probiotics and Omega-3/vitamin D Supplements- Elderly

EXPERIMENTAL

Dietary Supplement: Probiotic, Omega-3, Vitamin D supplement

Placebo- Elderly

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Probiotics and Omega-3/vitamin D Supplements- Obese

EXPERIMENTAL

Dietary Supplement: Probiotic, Omega-3, Vitamin D supplement

Placebo- Obese

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Probiotic, Omega-3, Vitamin D supplement DIETARY_SUPPLEMENT

The first supplement we would like to assess is named VNP and is composed by Omega-3 Active and vitamin D. It contains a total of 1100 mg fish oils: 640 mg Omega-3 and with 300 mg eicosapentaenoic acid (EPA), 220 mg docosahexaenoic acid (DHA) plus 200 IU Vitamin D per daily dose (2 capsules). The second supplement we investigate is four-strain probiotics combination based on the commercially available formulation HOWARU® by DuPont; two capsules containing 10 billion CFU total (supplied by Pfizer but manufactured by Danisco, DuPont). The probiotic specific composition, contains equal amounts of each strain per capsule (1.25 x 109 CFU each): Bifidobacterium lactis Bi-07, Lactobacillus paracasei Lpc-37, Lactobacillus acidophilus NCFM, Bifidobacterium lactis Bl-04. One capsule contains 5 billion CFU (Swedish milliards).

Probiotics and Omega-3/vitamin D Supplements- Elderly; Probiotics and Omega-3/vitamin D Supplements- Obese

Placebo DIETARY_SUPPLEMENT

Placebo generated for probiotic and omega-3/vitamin D supplements

Placebo- Elderly; Placebo- Obese

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old for elderly arms
• years old for obese arms
• screening hs-CRP of 1.5-6 mg/L for elderly
• screening hs-CRP of 2-10 mg/L for obese
• BMI 18.5-27 for elderly
• BMI 28-40 for obese
• Signed informed consent prior to any study related procedures
• Prospect to start the study the latest 6 weeks after the screening visit although preferably as soon as they receive the screening results
• Willing to abstain from regular consumption of probiotic supplements, products containing probiotic bacteria
• Willing to fast at least 5 hours during the sugar-permeability-test and receive a standardised breakfast (e.g. Cereal bar) or other standardised meal
• Accepting to drink at least 1.5 litres of provided water in one day, during the two time points where the sugar test is performed

You may not qualify if:

• Diagnosis of type 1 and/or type 2 diabetes
• More than 4 hours/week exercise habits
• Immobile, defined as the inability to participate in all study related procedures
• Dietary intake of fatty fish, fish oils containing omega-3 or pure omega- 3 supplements more than 2 times/week
• History of complicated gastrointestinal surgery
• Diagnosed Inflammatory Bowel Disease (IBD)
• Current diagnosis of psychiatric disease/s or syndromes
• Any condition which could interfere with the intestinal barrier function (e.g. gluten sensitivity, lactose intolerance, celiac disease, IBS, IBD) as decided by the principal investigators´ discretion
• Drinking more than 9 standard cups of alcohol per week and/or more than 3 standard cups of alcohol per occasion.
• Regular smoking, use of snuff, nicotine or e-cigarette use
• Any disorder which according to the principal investigator can have an anti-inflammatory effect and/or can affect the intestinal barrier function, or that can impact an adequate analysis of the study outcomes
• After being included in the study, starting with a medication/treatment or medical intervention that could potentially influence the study participation and/or the study analysis (e.g. the event of a fracture)
• Radical change in diet (e.g. becoming vegetarian or if they discover that they are lactose intolerant) during the study period
• Allergic to fish
• Allergic to milk- or soy protein

Sponsors & Collaborators

• Örebro University, Sweden: lead
• University of Hohenheim: collaborator
• Pfizer: collaborator

Study Sites (1)

Örebo University

Örebro, 703 62, Sweden

Location

MeSH Terms

Conditions

Inflammation

Interventions

Probiotics; Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Robert JM Brummer, Prof MD PhD

  Örebro University, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Gastroenterology and Clinical Nutrition, Director Nutrition-Gut-Brain Interactions Research Centre

Model Details: proof-of-concept, randomized double-blinded placebo-controlled parallel study

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: October 15, 2019
• Study Start: September 11, 2019
• Primary Completion: May 15, 2020
• Study Completion: December 15, 2020
• Last Updated: February 24, 2021

Record last verified: 2021-02

Locations

SE (1)