Demonstration of the Prebiotic-like Effects of Camu-camu Consumption Against Obesity-related Disorders in Humans

October 3, 2022 updated by: André Marette, Laval University

Previous work of the investigators demonstrated the anti-obesity and anti-steatosis potential of the Amazonian fruit camu-camu (CC) in a mouse model of diet-induced obesity [1]. It was demonstrated that the prebiotic role of CC was directly linked to higher energy expenditure stimulated by the fruit since fecal transplantation from CC-treated mice to germ-free mice was sufficient to reproduce the effects.

The full protection against hepatic steatosis observed in CC-treated mice is of particular importance since nonalcoholic fatty liver disease (NAFLD) is one of the most common causes of chronic liver disease. Thirty percent of adults in developed countries have excess fat accumulation in the liver, and this figure can be as high as 80% in obese subjects. NAFLD is an umbrella term encompassing simple steatosis, as well as non-alcoholic steatohepatitis which can lead to cirrhosis and hepatocellular carcinoma in up to 20% of cases. Up to now, except for lifestyle changes, no effective drug treatment are available. Previous work has suggested that CC possesses anti-inflammatory properties and could acutely reduce blood pressure and glycemia after a single intake. While CC could represent a promising treatment for obesity and fatty liver, no studies have thoroughly tested this potential in humans. Therefore, a robust clinical proof of concept study is needed to provide convincing evidence for a microbiome-based therapeutic strategy to counteract obesity and its associated metabolic disorders.

The mechanism of action of CC could involve bile acid (BA) metabolism. BA are produced in the liver and metabolized in the intestine by the gut microbiota. Conversely, they can modulate gut microbial composition. BA and particularly, primary BA, are powerful regulators of metabolism. Indeed, mice treated orally with the primary BA α, β muricholic (αMCA, βMCA) and cholic acids (CA) were protected from diet-induced obesity and hepatic lipid accumulation. Interestingly, the investigators reported that administration of CC to mice increased the levels of αMCA, βMCA and CA. Primary BA are predominantly secreted conjugated to amino acids and that deconjugation rely on the microbial enzymatic machinery of gut commensals. The increased presence of the deconjugated primary BA in CC-treated mice indicate that a cluster of microbes selected by CC influence the BA pool composition. These data therefore point to an Interplay between BA and gut microbiota mediating the health effects of CC.

Polyphenols and in particular procyanidins and ellagitannins in CC can also be responsible for the modulation of BA that can impact on the gut microbiota. Indeed, it has been reported that ellagitannins containing food like walnuts modulate secondary BA in humans whereas procyanidins can interact with farnesoid X receptors and alter BA recirculation to reduce hypertriglyceridemia. These effects are likely mediated by the remodeling of the microbiota by the polyphenols.

In accordance with the hypothesis that the ultimate effect of CC is directly linked to a modification of the microbiota, fecal transplantation from CC-treated mice to germ-free mice was sufficient to recapitulate the lower weight gain and the higher energy expenditure seen in donor mice.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Québec, Canada, G1V 0A6
        • INAF, Université Laval

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI between 25 and 40 kg/m2
  • Fasting triglyceride > 1,35 mmol/L
  • Understanding of spoken and written french
  • Accept to follow study instructions

Exclusion Criteria:

  • Smoking
  • Medication affecting glucose metabolism, blood lipid levels or blood pressure
  • Metabolic disorders requiring treatment
  • Diabetic subjects presenting HbA1c >6.5% or fasting glycemia >7 mmol/L
  • Consumption of fruit or polyphenol supplements in the last 3 months
  • Allergy or intolerance for camu camu or for an ingredient of the placebo
  • Alcohol consumption of > 2 drinks / day
  • Weight change > 5% of body weight in the last 3 months
  • Major surgical operation in the last 3 months or planned in the next months
  • Pregnant or breastfeeding women or women planning pregnancy in the next months
  • Antibiotics intake in the last 3 months
  • Regular probiotics intake in the last 3 months
  • Gastrointestinal malabsorption
  • Cirrhosis
  • Chronic kidney disease
  • Concomitant participation in another clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
3 capsules of placebo daily during 12 weeks
Experimental: Camu camu
3 capsules of camu camu powder (500 mg / capsule) daily during 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Gut Microbiota Composition and Diversity
Time Frame: Change between the beginning and the end of each treatment (12 weeks each)
Global variation of the fecal microbiota
Change between the beginning and the end of each treatment (12 weeks each)
Change in fat accumulation in the liver
Time Frame: Change between the beginning and the end of each treatment (12 weeks each)
Evaluation of fat accumulation by magnetic resonance imaging (MRI)
Change between the beginning and the end of each treatment (12 weeks each)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Endotoxemia
Time Frame: Change between the beginning and the end of each treatment (12 weeks each)
Plasma Lipopolysaccharides (LPS) and Lipopolysaccharide Binding Protein (LBP)
Change between the beginning and the end of each treatment (12 weeks each)
Change in Intestinal permeability
Time Frame: Change between the beginning and the end of each treatment (12 weeks each)
Plasma zonulin
Change between the beginning and the end of each treatment (12 weeks each)
Change in Inflammation state of the tissue
Time Frame: Change between the beginning and the end of each treatment (12 weeks each)
Fecal calprotectin and chromogranin
Change between the beginning and the end of each treatment (12 weeks each)
Change in Short chain and branched chain fatty acids in the feces
Time Frame: Change between the beginning and the end of each treatment (12 weeks each)
Measure short chain fatty acids in the feces
Change between the beginning and the end of each treatment (12 weeks each)
Change in gut health
Time Frame: Change between the beginning and the end of each treatment (12 weeks each)
Evaluation of gastrointestinal symptoms using a standardized questionnaire (the gastrointestinal symptom rating scale (GSRS))
Change between the beginning and the end of each treatment (12 weeks each)
Change in stool consistency
Time Frame: Change between the beginning and the end of each treatment (12 weeks each)
Evaluation of stool consistency using a standardized questionnaire (Bristol stool chart)
Change between the beginning and the end of each treatment (12 weeks each)
Change in Glucose homeostasis
Time Frame: Change between the beginning and the end of each treatment (12 weeks each)
Evaluation of plasma glucose using a 3-hour oral glucose tolerance test
Change between the beginning and the end of each treatment (12 weeks each)
Change in Glucose homeostasis
Time Frame: Change between the beginning and the end of each treatment (12 weeks each)
Evaluation of insulin concentration using a 3-hour oral glucose tolerance test
Change between the beginning and the end of each treatment (12 weeks each)
Change in Glucose homeostasis
Time Frame: Change between the beginning and the end of each treatment (12 weeks each)
Evaluation of c-peptide concentration using a 3-hour oral glucose tolerance test
Change between the beginning and the end of each treatment (12 weeks each)
Change in Glucose homeostasis
Time Frame: Change between the beginning and the end of each treatment (12 weeks each)
Evaluation of glycated haemoglobin
Change between the beginning and the end of each treatment (12 weeks each)
Change in Lipid profile
Time Frame: Change between the beginning and the end of each treatment (12 weeks each)
Evaluation of plasma triglycerides (TG), Total cholesterol, LDL, HDL, Apolipoprotein B and free fatty acids
Change between the beginning and the end of each treatment (12 weeks each)
Change in anthropometric measurements
Time Frame: Change between the beginning and the end of each treatment (12 weeks each)
Evaluation of BMI (measured with weight change and height throughout the protocol)
Change between the beginning and the end of each treatment (12 weeks each)
Change in anthropometric measurements
Time Frame: Change between the beginning and the end of each treatment (12 weeks each)
Evaluation of waist circumference
Change between the beginning and the end of each treatment (12 weeks each)
Change in body composition
Time Frame: Change between the beginning and the end of each treatment (12 weeks each)
Evaluation of body composition by osteodensitometry
Change between the beginning and the end of each treatment (12 weeks each)
Change in chronic inflammation
Time Frame: Change between the beginning and the end of each treatment (12 weeks each)
Evaluation of plasma high sensitive C-Reactive Protein (hs-CRP)
Change between the beginning and the end of each treatment (12 weeks each)
Change in liver health
Time Frame: Change between the beginning and the end of each treatment (12 weeks each)
Evaluation of aspartate transaminase and alanine aminotransferase (AST and ALT)
Change between the beginning and the end of each treatment (12 weeks each)
Change in gene expression levels
Time Frame: Change between the beginning and the end of each treatment (12 weeks each)
Transcriptomic analyses to investigate underlying mechanisms of action
Change between the beginning and the end of each treatment (12 weeks each)
Change in circulating levels of plasma metabolites
Time Frame: Change between the beginning and the end of each treatment (12 weeks each)
Evaluation of camu-camu derived metabolites, short chain fatty acids, branched chain fatty acids, bile acids, phenolic compounds
Change between the beginning and the end of each treatment (12 weeks each)
Change in camu camu-derived metabolites present in stool
Time Frame: Change between the beginning and the end of each treatment (12 weeks each)
Evaluation of metabolome: camu-camu derived metabolites, short chain fatty acids, branched chain fatty acids, bile acids, phenolic compounds
Change between the beginning and the end of each treatment (12 weeks each)
Change in blood pressure
Time Frame: Change between the beginning and the end of each treatment (12 weeks each)
Evaluation of systolic and diastolic blood pressure
Change between the beginning and the end of each treatment (12 weeks each)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2020

Primary Completion (Actual)

April 21, 2022

Study Completion (Actual)

April 21, 2022

Study Registration Dates

First Submitted

October 3, 2019

First Submitted That Met QC Criteria

October 15, 2019

First Posted (Actual)

October 17, 2019

Study Record Updates

Last Update Posted (Actual)

October 4, 2022

Last Update Submitted That Met QC Criteria

October 3, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • CAMU 2020-3350

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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