An interventional study of Camu camu and Placebo in Overweight, Microtia and Endotoxemia, sponsored by Laval University. Completed at 1 site in Canada. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-04.
Sponsored by Laval University · Not applicable, Interventional, and Prevention
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.
3,599 studies on the registry are indexed under Overweight; 852 are open to participants now.
This study's enrollment of 35 is below the median of 78 across 3,120 interventional studies indexed under Overweight.
Browse Overweight studies →Laval University is the lead sponsor of 380 studies on the registry; 67 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dietary Supplement: Camu camu
Dietary Supplement: Placebo
Drug pages: Myrciaria dubia · Camu-camu fruit
3 capsules of camu camu powder (500 mg / capsule) daily during 12 weeks
3 capsules of placebo daily during 12 weeks
Change in Gut Microbiota Composition and Diversity
Global variation of the fecal microbiota
Time frame: Change between the beginning and the end of each treatment (12 weeks each)
Change in fat accumulation in the liver
Evaluation of fat accumulation by magnetic resonance imaging (MRI)
Time frame: Change between the beginning and the end of each treatment (12 weeks each)
Change in Endotoxemia
Plasma Lipopolysaccharides (LPS) and Lipopolysaccharide Binding Protein (LBP)
Time frame: Change between the beginning and the end of each treatment (12 weeks each)
Change in Intestinal permeability
Plasma zonulin
Time frame: Change between the beginning and the end of each treatment (12 weeks each)
Change in Inflammation state of the tissue
Fecal calprotectin and chromogranin
Time frame: 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
Measure short chain fatty acids in the feces
Time frame: Change between the beginning and the end of each treatment (12 weeks each)
Change in gut health
Evaluation of gastrointestinal symptoms using a standardized questionnaire (the gastrointestinal symptom rating scale (GSRS))
Time frame: Change between the beginning and the end of each treatment (12 weeks each)
Change in stool consistency
Evaluation of stool consistency using a standardized questionnaire (Bristol stool chart)
Time frame: Change between the beginning and the end of each treatment (12 weeks each)
Change in Glucose homeostasis
Evaluation of plasma glucose using a 3-hour oral glucose tolerance test
Time frame: Change between the beginning and the end of each treatment (12 weeks each)
Change in Glucose homeostasis
Evaluation of insulin concentration using a 3-hour oral glucose tolerance test
Time frame: Change between the beginning and the end of each treatment (12 weeks each)
Change in Glucose homeostasis
Evaluation of c-peptide concentration using a 3-hour oral glucose tolerance test
Time frame: Change between the beginning and the end of each treatment (12 weeks each)
Change in Glucose homeostasis
Evaluation of glycated haemoglobin
Time frame: Change between the beginning and the end of each treatment (12 weeks each)
Change in Lipid profile
Evaluation of plasma triglycerides (TG), Total cholesterol, LDL, HDL, Apolipoprotein B and free fatty acids
Time frame: Change between the beginning and the end of each treatment (12 weeks each)
Change in anthropometric measurements
Evaluation of BMI (measured with weight change and height throughout the protocol)
Time frame: Change between the beginning and the end of each treatment (12 weeks each)
Change in anthropometric measurements
Evaluation of waist circumference
Time frame: Change between the beginning and the end of each treatment (12 weeks each)
Change in body composition
Evaluation of body composition by osteodensitometry
Time frame: Change between the beginning and the end of each treatment (12 weeks each)
Change in chronic inflammation
Evaluation of plasma high sensitive C-Reactive Protein (hs-CRP)
Time frame: Change between the beginning and the end of each treatment (12 weeks each)
Change in liver health
Evaluation of aspartate transaminase and alanine aminotransferase (AST and ALT)
Time frame: Change between the beginning and the end of each treatment (12 weeks each)
Change in gene expression levels
Transcriptomic analyses to investigate underlying mechanisms of action
Time frame: Change between the beginning and the end of each treatment (12 weeks each)
Change in circulating levels of plasma metabolites
Evaluation of camu-camu derived metabolites, short chain fatty acids, branched chain fatty acids, bile acids, phenolic compounds
Time frame: Change between the beginning and the end of each treatment (12 weeks each)
Change in camu camu-derived metabolites present in stool
Evaluation of metabolome: camu-camu derived metabolites, short chain fatty acids, branched chain fatty acids, bile acids, phenolic compounds
Time frame: Change between the beginning and the end of each treatment (12 weeks each)
Change in blood pressure
Evaluation of systolic and diastolic blood pressure
Time frame: Change between the beginning and the end of each treatment (12 weeks each)
Ran from Oct 2020 to primary completion in Apr 2022, 17 months.
Of 1,300 non-industry interventional studies with no phase under Overweight, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 38. This study's 17 months is close to that.
Counting every sponsor, half of 1,411 studies reached it within 17 months; a quarter within 8 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Myrciaria dubia · Camu-camu fruit