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Completed

NCT Number: NCT04130321

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Camu camu

Dietary Supplement

3 capsules of camu camu powder (500 mg / capsule) daily during 12 weeks

Placebo

Dietary Supplement

3 capsules of placebo daily during 12 weeks

Primary outcomes

  1. 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

  2. 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)

Secondary outcomes

  1. 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)

  2. Change in Intestinal permeability

    Time frame: Change between the beginning and the end of each treatment (12 weeks each)

    Plasma zonulin

  3. 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

  4. 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

  5. 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))

  6. 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)

  7. 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

  8. 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

  9. 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

  10. Change in Glucose homeostasis

    Time frame: Change between the beginning and the end of each treatment (12 weeks each)

    Evaluation of glycated haemoglobin

  11. 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

  12. 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)

  13. Change in anthropometric measurements

    Time frame: Change between the beginning and the end of each treatment (12 weeks each)

    Evaluation of waist circumference

  14. 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

  15. 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)

  16. 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)

  17. 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

  18. 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

  19. 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

  20. 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

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 17, 2019
Registry last updated
Oct 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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