MicrobiotaNCT03327441
Benefits of Almond Consumption in Modulation of Intestinal Microbiome and Novel Disease Risk Biomarkers
A study testing Almonds and Omelette in people with Microbiota, run by University of Manitoba at 1 site in Canada.
Trial summary
The overall goal is to assess the health benefits of almond consumption on gut microbiome patterns and their association with circulating disease risk biomarkers, as well as the processes that control those pathways. Health benefits will be assessed relative to a omelette control. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Microbiota
- What is being tested?
- Almonds and Omelette
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2018to 31 Aug 2019
- 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
- Able to give written informed consent
- Men and women 18-75 yr
- Elevated waist circumferences (women greater than or equal to 80 cm, men greater than or equal to 94 cm)
- LDL-C greater than or equal to 2.8 mmol/L, or less than or equal to 4.9 mmol/L
- Non-smokers
- Possess a telephone or email address to enable regular contact
- Able to read, write and speak English
Who cannot join
- Pregnant female, or planning to become pregnant during the study period
- Weight gain or loss of at least 10lbs in previous three months
- Allergic to almonds, eggs, milk
- Exercising > 15 miles/wk or 4,000 kcal/wk
- Those currently taking (or have taken within the past 3 months) lipid-lowering medications (i.e., statins)
- Those currently taking (or have taken within the last 3 months) lipid-lowering supplements (i.e., omega-3 supplements, plant sterols/stanol foods and/or supplements, fibre, etc.)
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- Those currently taking (or have taken within the last 3 months) probiotic supplements and foods containing added probiotics (i.e., kefir, Activia, Kashi: Vive Probiotic Digestive Wellness Cereal)
- Previous history of diabetes, hypertension, gastrointestinal disease, liver or lung disease or cancer, hyperthyroidism or hypothyroidism, or lung disease.
- Alcohol use of >2 drinks/day
Trial locations and contacts
1 site in 1 country.
Canada1 site
Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
Winnipeg, Manitoba, R3T 6C5
About this study
Official title: Benefits of Almond Consumption in Modulation of Intestinal Microbiome and Novel Disease Risk Biomarkers: A Randomized Controlled Dietary Intervention Trial
The overall goal is to assess the health benefits of almond consumption on gut microbiome patterns and their association with circulating disease risk biomarkers, as well as the processes that control those pathways. Health benefits will be assessed relative to a omelette control.
Read the detailed description
Men and women with elevated waist circumference aged between 18-75 yrs will be recruited from the Winnipeg (Manitoba, Canada) area to participate in a two arm crossover, randomized study; each treatment period will be 4 weeks in length, with a 4 week washout period separating each treatment. Participants will be randomized to consume either i) almonds, or ii) omelettes at 15% of energy. Each of the treatment products will contain equal levels of calories.
- Conditions
- Microbiota
- Being tested
- Almonds, Omelette
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlmondsOther
Almonds will be provided as 15% energy
OmeletteOther
Omelettes will be provided as 15% energy
| Study group | Role | What they receive |
|---|---|---|
| Almonds | Experimental | Not described Receives: Other: Almonds |
| Omelette | Active comparator | Not described Receives: Other: Omelette |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal microbiome
Bacterial community alpha-diversity measured using richness and diversity indices including Chao1, Shannon, Inverse Simpson.
Bacterial community beta-diversity measured using weighted and unweighted UniFrac distances.
The most abundant Operational Taxonomic Units (OTUs) within the bacterial community identified based on the relative abundances of the OTUs within the community.
Bacterial community composition at the phylum and genus levels described based on the relative abundances of each taxa within the community.
Bacterial community functional capacity measured based on the relative abundances of collected predicted functions of the community members.
Ecological relationships between members of bacterial community assessed using correlation network modelling to identify keystone and foundation members of the bacterial community that have the highest number of positive (supportive) or negative (suppressive) connections (>15) with other members of community.
Measured: 4 weeks
Secondary outcomes (21)
Blood total cholesterol
Measured: 4 weeks
Blood low-density lipoprotein cholesterol
Measured: 4 weeks
Blood high-density lipoprotein cholesterol
Measured: 4 weeks
Blood triglycerides
Measured: 4 weeks
Interferon gamma
Measured: 4 weeks
Interleukin 1 beta
Measured: 4 weeks
Interleukin 6
Measured: 4 weeks
Tumor necrosis factor alpha
Measured: 4 weeks
Serum amyloid A
Measured: 4 weeks
C-reactive protein
Measured: 4 weeks
Vascular cell adhesion molecule 1
Measured: 4 weeks
Intercellular adhesion molecule 1
Measured: 4 weeks
7α-hydroxy-4-cholesten-3-one
Measured: 4 weeks
Fecal short chain fatty acids
Measured: 4 weeks
Fatty acid synthesis rate
Measured: 4 weeks
Cholesterol synthesis rate
Measured: 4 weeks
Cholesterol absorption rate
Measured: 4 weeks
Body mass index
Weight and height will be combined to report BMI in kg/m^2
Measured: 4 weeks
Waist circumference
Measured: 4 weeks
Hip circumference
Measured: 4 weeks
Blood pressure
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start1 Feb 2018
- Primary completion30 Apr 2019
- Study completion31 Aug 2019
Why it stopped: Decision of the funder: Almond Board of California
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrobiotaStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Almond Board of California
- Responsible party
- Sponsor
- Investigators
- Rotimi Aluko, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03327441
- Sponsor's protocol ID
- B2017:105
- Status last verified
- Apr 2021
- First submitted
- 23 Oct 2017
- Last updated
- 17 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Almond Consumption in Modulation of Intestinal Microbiome and Novel Disease Risk Biomarkers: A Randomized Controlled Dietary Intervention Trial
- ClinicalTrials.gov ID
- NCT03327441
- Acronym / sponsor ID
- B2017:105
- Conditions
- Microbiota
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Decision of the funder: Almond Board of California
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Almond Board of California
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 31 Oct 2017 (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.
The overall goal is to assess the health benefits of almond consumption on gut microbiome patterns and their association with circulating disease risk biomarkers, as well as the processes that control those pathways. Health benefits will be assessed relative to a omelette control.
Detailed description
Men and women with elevated waist circumference aged between 18-75 yrs will be recruited from the Winnipeg (Manitoba, Canada) area to participate in a two arm crossover, randomized study; each treatment period will be 4 weeks in length, with a 4 week washout period separating each treatment. Participants will be randomized to consume either i) almonds, or ii) omelettes at 15% of energy. Each of the treatment products will contain equal levels of calories.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Almonds | Experimental | Other: Almonds |
| Omelette | Active comparator | Other: Omelette |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able to give written informed consent
- Men and women 18-75 yr
- Elevated waist circumferences (women greater than or equal to 80 cm, men greater than or equal to 94 cm)
- LDL-C greater than or equal to 2.8 mmol/L, or less than or equal to 4.9 mmol/L
- Non-smokers
Key exclusion criteria (9 listed)
- Pregnant female, or planning to become pregnant during the study period
- Weight gain or loss of at least 10lbs in previous three months
- Allergic to almonds, eggs, milk
- Exercising > 15 miles/wk or 4,000 kcal/wk
- Those currently taking (or have taken within the past 3 months) lipid-lowering medications (i.e., statins)
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 |
|---|---|---|
| AlmondsAlmonds will be provided as 15% energy | Other | Almonds |
| OmeletteOmelettes will be provided as 15% energy | Other | Omelette |
Primary outcome
Gastrointestinal microbiome
Time frame: 4 weeks
Bacterial community alpha-diversity measured using richness and diversity indices including Chao1, Shannon, Inverse Simpson. Bacterial community beta-diversity measured using weighted and unweighted UniFrac distances. The most abundant Operational Taxonomic Units (OTUs) within the bacterial community identified based on the relative abundances of the OTUs within the community. Bacterial community composition at the phylum and genus levels described based on the relative abundances of each taxa within the community. Bacterial community functional capacity measured based on the relative abundances of collected predicted functions of the community members. Ecological relationships between members of bacterial community assessed using correlation network modelling to identify keystone and foundation members of the bacterial community that have the highest number of positive (supportive) or negative (suppressive) connections (>15) with other members of community.
21 secondary outcomes
Blood total cholesterol
Time frame: 4 weeks
Blood low-density lipoprotein cholesterol
Time frame: 4 weeks
Blood high-density lipoprotein cholesterol
Time frame: 4 weeks
Blood triglycerides
Time frame: 4 weeks
Interferon gamma
Time frame: 4 weeks
Interleukin 1 beta
Time frame: 4 weeks
Interleukin 6
Time frame: 4 weeks
Tumor necrosis factor alpha
Time frame: 4 weeks
Serum amyloid A
Time frame: 4 weeks
C-reactive protein
Time frame: 4 weeks
Vascular cell adhesion molecule 1
Time frame: 4 weeks
Intercellular adhesion molecule 1
Time frame: 4 weeks
7α-hydroxy-4-cholesten-3-one
Time frame: 4 weeks
Fecal short chain fatty acids
Time frame: 4 weeks
Fatty acid synthesis rate
Time frame: 4 weeks
Cholesterol synthesis rate
Time frame: 4 weeks
Cholesterol absorption rate
Time frame: 4 weeks
Body mass index
Time frame: 4 weeks
Waist circumference
Time frame: 4 weeks
Hip circumference
Time frame: 4 weeks
Blood pressure
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: Decision of the funder: Almond Board of California). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
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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.
Rotimi Aluko, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Almonds and Omelette in people with Microbiota, run by University of Manitoba 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 7 inclusion and 9 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: stopped early, as of the sponsor's last update on 17 Mar 2023. 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. 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 was stopped early (reason given: Decision of the funder: Almond Board of California). Results are not available in the source record.
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?
Gastrointestinal microbiome (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2023.