OverweightNCT04130321
Demonstration of the Prebiotic-like Effects of Camu-camu Consumption Against Obesity-related Disorders in Humans
A study testing Camu camu in people with Overweight and Microtia, run by Laval University at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Microtia, Endotoxemia
- What is being tested?
- Camu camu
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- 31 Oct 2020to 21 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI between 25 and 40 kg/m2
- Fasting triglyceride > 1,35 mmol/L
- Understanding of spoken and written french
- Accept to follow study instructions
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Overweight, Microtia, Endotoxemia, Metabolic Syndrome, Insulin Resistance, Non-Alcoholic Fatty Liver Disease
- Being tested
- Camu camu, Placebo
- Medical subject headings
- Overweight, Congenital Microtia, Endotoxemia, Metabolic Syndrome, Insulin Resistance, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camu camuDietary supplement
3 capsules of camu camu powder (500 mg / capsule) daily during 12 weeks
PlaceboDietary supplement
3 capsules of placebo daily during 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Camu camu | Experimental | Not described Receives: Dietary Supplement: Camu camu |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gut Microbiota Composition and Diversity
Global variation of the fecal microbiota
Measured: 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)
Measured: Change between the beginning and the end of each treatment (12 weeks each)
Secondary outcomes (20)
Change in Endotoxemia
Plasma Lipopolysaccharides (LPS) and Lipopolysaccharide Binding Protein (LBP)
Measured: Change between the beginning and the end of each treatment (12 weeks each)
Change in Intestinal permeability
Plasma zonulin
Measured: Change between the beginning and the end of each treatment (12 weeks each)
Change in Inflammation state of the tissue
Fecal calprotectin and chromogranin
Measured: 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
Measured: 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))
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: Change between the beginning and the end of each treatment (12 weeks each)
Change in Glucose homeostasis
Evaluation of glycated haemoglobin
Measured: 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
Measured: 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)
Measured: Change between the beginning and the end of each treatment (12 weeks each)
Change in anthropometric measurements
Evaluation of waist circumference
Measured: Change between the beginning and the end of each treatment (12 weeks each)
Change in body composition
Evaluation of body composition by osteodensitometry
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: Change between the beginning and the end of each treatment (12 weeks each)
Change in blood pressure
Evaluation of systolic and diastolic blood pressure
Measured: Change between the beginning and the end of each treatment (12 weeks each)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start31 Oct 2020
- Primary completion21 Apr 2022
- Study completion21 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, André Marette, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04130321
- Sponsor's protocol ID
- CAMU 2020-3350
- Status last verified
- Oct 2022
- First submitted
- 3 Oct 2019
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Agrinier AL, Morissette A, Daoust L, Gignac T, Marois J, Varin TV, Pilon G, Larose E, Gagnon C, Desjardins Y, Anhe FF, Carreau AM, Vohl MC, Marette A. Camu-camu decreases hepatic steatosis and liver injury markers in overweight, hypertriglyceridemic individuals: A randomized crossover trial. Cell Rep Med. 2024 Aug 20;5(8):101682. doi: 10.1016/j.xcrm.2024.101682.
PubMed 39168095
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demonstration of the Prebiotic-like Effects of Camu-camu Consumption Against Obesity-related Disorders in Humans
- ClinicalTrials.gov ID
- NCT04130321
- Acronym / sponsor ID
- CAMU 2020-3350
- Conditions
- Overweight, Microtia, Endotoxemia, Metabolic Syndrome, Insulin Resistance, Non-Alcoholic Fatty Liver Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 31 Oct 2020 (actual)
- Primary completion
- 21 Apr 2022 (actual)
- Study completion
- 21 Apr 2022 (actual)
- First posted
- 17 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Camu camu | Experimental | Dietary Supplement: Camu camu |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI between 25 and 40 kg/m2
- Fasting triglyceride > 1,35 mmol/L
- Understanding of spoken and written french
- Accept to follow study instructions
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Camu camu3 capsules of camu camu powder (500 mg / capsule) daily during 12 weeks | Dietary supplement | Camu camu |
| Placebo3 capsules of placebo daily during 12 weeks | Dietary supplement | Placebo |
Primary outcome
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 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)
20 secondary outcomes
Change in Endotoxemia
Time frame: 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)
Change in Inflammation state of the tissue
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
Time frame: 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)
Change in stool consistency
Time frame: 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)
Change in Glucose homeostasis
Time frame: 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)
Change in Glucose homeostasis
Time frame: 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)
Change in anthropometric measurements
Time frame: 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)
Change in body composition
Time frame: 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)
Change in liver health
Time frame: 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)
Change in circulating levels of plasma metabolites
Time frame: 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)
Change in blood pressure
Time frame: Change between the beginning and the end of each treatment (12 weeks each)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Derived from this study: PubMed 39168095Agrinier AL, Morissette A, Daoust L, Gignac T, Marois J, Varin TV, Pilon G, Larose E, Gagnon C, Desjardins Y, Anhe FF, Carreau AM, Vohl MC, Marette A. Camu-camu decreases hepatic steatosis and liver injury markers in overweight, hypertriglyceridemic individuals: A randomized crossover trial. Cell Rep Med. 2024 Aug 20;5(8):101682. doi: 10.1016/j.xcrm.2024.101682.
Related trials for Overweight
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Camu camu in people with Overweight and Microtia, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gut Microbiota Composition and Diversity (time frame: Change between the beginning and the end of each treatment (12 weeks each)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04130321, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2022.