Overweight and ObesitySNACKingNCT04223323
Effects of Almond Consumption on the Human Gastrointestinal Microbiota and Metabolic Health
A study testing Almonds and Pretzels in people with Overweight and Obesity, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
The proposed work will investigate the effect of almond consumption as a snack on human gastrointestinal microbiota and on metabolic health. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Almonds and Pretzels
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2020to 20 Dec 2023
- 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males \& Females
- 30-60 years of age
- BMI 25-34.9 kg/m^2
- Ability to drop off fecal sample within 15 minutes of defecation
Who cannot join
- Physician diagnosed metabolic or gastrointestinal diseases
- Fasting blood glucose >126 mg/dL
- Blood pressure >160/100 mm Hg
- Anemia
- Elevation in serum transaminases (i.e. >3 times the upper limit of normal)
- Evidence of liver disease, including primary biliary cirrhosis or gallbladder disease, constipation
Show all 18Show fewer
- Currently taking lipid-lowering medications, oral hypoglycemic agents, or insulin, or medications known to impact bowel function.
- Pregnant, breastfeeding or postmenopausal
- Smoker, tobacco use
- Allergic to nuts
- Consume > 2 alcoholic beverages/day
- Abuse drugs
- Have had > 5% weight change in the past month or > 10% change in the past year
- Have taken antibiotics during the previous 2 months
- Unable to consume the experimental treatments (almonds or pretzels)
- Bariatric surgery
- Gallbladder removal
- Allergic to lidocaine or other topical anesthetics
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Urbana-Champaign
Urbana, Illinois, 61801
About this study
Official title: SNACKing Study: Effects of Snacking on the Gastrointestinal Microbiota and Metabolism
The proposed work will investigate the effect of almond consumption as a snack on human gastrointestinal microbiota and on metabolic health.
Read the detailed description
This study is a randomized, controlled, investigator-blinded, parallel arm design with two treatment conditions. There will be a phone screening, in person pre-intervention testing, a one-week baseline period devoid of all nuts and seeds followed by a 12-week intervention period, and a post-testing appointment. Participants will be randomized to consume almonds or isocaloric snack for 12 weeks. Participants will provide stool samples during baseline testing and during the 12th week of the intervention.
- Conditions
- Overweight and Obesity
- Being tested
- Almonds, Pretzels
- Keywords
- Almond, Gastrointestinal microbiota, Metabolic health, Bile acid profiles
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlmondsDietary supplement
Participants in the intervention group will consume 2oz of almonds daily over the course of 12 weeks.
PretzelsDietary supplement
Participants in the control group will consume an isocaloric amount of pretzels daily over the course of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention arm consists of daily consumption of the investigator's intervention snack over the course of 12 weeks. Receives: Dietary Supplement: Almonds |
| Isocaloric Control | Placebo comparator | The control arm consists of daily consumption of an isocaloric snack over the course of 12 weeks. Receives: Dietary Supplement: Pretzels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in gastrointestinal microbiota composition
Determine the impact of daily consumption of almonds on the gastrointestinal microbiota compared to control (pretzels) by sequencing the V4 region of the 16S rRNA gene in fecal samples.
Measured: Baseline & 12-week mark
Changes in abundance of fecal Roseburia spp
Determine the impact of daily consumption of almonds on the abundance of Roseburia spp. compared to control (pretzels) by using quantitative real-time PCR.
Measured: Baseline & 12-week mark
Changes in abundance of fecal Butyryl CoA: Acetate CoA transferase
Determine the impact of daily consumption of almonds on the abundance of Butyryl CoA: Acetate CoA transferase gene compared to control (pretzels) by using quantitative real-time PCR.
Measured: Baseline & 12-week mark
Changes in gastrointestinal microbial-derived metabolite concentrations
Determine the impact of daily consumption of almonds on the concentration of microbial-derived metabolites compared to control (pretzels) by using gas-liquid chromatography. These metabolites include butyrate and secondary bile acids.
Measured: Baseline & 12-week mark
Secondary outcomes (3)
Changes in liver fat
Determine the impact of daily consumption of almonds on liver fat percentages compared to control (pretzels) by quantitative liver ultrasound.
Measured: Baseline & 12-week mark
Changes in glycemic control.
Determine the impact on oral glucose tolerance within intervention (almond) and control (pretzel) groups by using a mixed meal tolerance test.
Measured: Baseline & 12-week mark
Changes in secondary measures of gastrointestinal health.
Determine the impact of daily consumption of almonds on gastrointestinal health compared to control (pretzels) by measuring fecal pH; other microbial fermentation end products and microbial-derived bile acids using gas-liquid chromatography; and alpha- and beta- diversity measures of the gut microbiota community structure using 16S microbiota analyses.
Measured: Baseline & 12-week mark
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start10 Feb 2020
- Primary completion20 Dec 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- Almond Board of California
- Responsible party
- Sponsor
- Investigators
- Hannah D Holscher, PhD RD, Principal investigator, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04223323
- Sponsor's protocol ID
- 20154
- Acronym
- SNACKing
- Status last verified
- Dec 2024
- First submitted
- 12 Nov 2019
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SNACKing Study: Effects of Snacking on the Gastrointestinal Microbiota and Metabolism
- ClinicalTrials.gov ID
- NCT04223323
- Acronym / sponsor ID
- SNACKing / 20154
- Conditions
- Overweight and Obesity
- Keywords
- Almond, Gastrointestinal microbiota, Metabolic health, Bile acid profiles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- Almond Board of California
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 10 Jan 2020 (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 proposed work will investigate the effect of almond consumption as a snack on human gastrointestinal microbiota and on metabolic health.
Detailed description
This study is a randomized, controlled, investigator-blinded, parallel arm design with two treatment conditions. There will be a phone screening, in person pre-intervention testing, a one-week baseline period devoid of all nuts and seeds followed by a 12-week intervention period, and a post-testing appointment. Participants will be randomized to consume almonds or isocaloric snack for 12 weeks. Participants will provide stool samples during baseline testing and during the 12th week of the intervention.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: AlmondsThe intervention arm consists of daily consumption of the investigator's intervention snack over the course of 12 weeks. |
| Isocaloric Control | Placebo comparator | Dietary Supplement: PretzelsThe control arm consists of daily consumption of an isocaloric snack over the course of 12 weeks. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males \& Females
- 30-60 years of age
- BMI 25-34.9 kg/m^2
- Ability to drop off fecal sample within 15 minutes of defecation
Key exclusion criteria (18 listed)
- Physician diagnosed metabolic or gastrointestinal diseases
- Fasting blood glucose >126 mg/dL
- Blood pressure >160/100 mm Hg
- Anemia
- Elevation in serum transaminases (i.e. >3 times the upper limit of normal)
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 |
|---|---|---|
| AlmondsParticipants in the intervention group will consume 2oz of almonds daily over the course of 12 weeks. | Dietary supplement | Intervention |
| PretzelsParticipants in the control group will consume an isocaloric amount of pretzels daily over the course of 12 weeks. | Dietary supplement | Isocaloric Control |
Primary outcome
Changes in gastrointestinal microbiota composition
Time frame: Baseline & 12-week mark
Determine the impact of daily consumption of almonds on the gastrointestinal microbiota compared to control (pretzels) by sequencing the V4 region of the 16S rRNA gene in fecal samples.
Changes in abundance of fecal Roseburia spp
Time frame: Baseline & 12-week mark
Determine the impact of daily consumption of almonds on the abundance of Roseburia spp. compared to control (pretzels) by using quantitative real-time PCR.
Changes in abundance of fecal Butyryl CoA: Acetate CoA transferase
Time frame: Baseline & 12-week mark
Determine the impact of daily consumption of almonds on the abundance of Butyryl CoA: Acetate CoA transferase gene compared to control (pretzels) by using quantitative real-time PCR.
Changes in gastrointestinal microbial-derived metabolite concentrations
Time frame: Baseline & 12-week mark
Determine the impact of daily consumption of almonds on the concentration of microbial-derived metabolites compared to control (pretzels) by using gas-liquid chromatography. These metabolites include butyrate and secondary bile acids.
3 secondary outcomes
Changes in liver fat
Time frame: Baseline & 12-week mark
Changes in glycemic control.
Time frame: Baseline & 12-week mark
Changes in secondary measures of gastrointestinal health.
Time frame: Baseline & 12-week mark
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 6 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Hannah D Holscher, PhD RD principal investigator
University of Illinois at Urbana-Champaign
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 Pretzels in people with Overweight and Obesity, run by University of Illinois at Urbana-Champaign at 1 site in United States.
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 18 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 6 Dec 2024. 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 United States. 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?
Changes in gastrointestinal microbiota composition (time frame: Baseline & 12-week mark). The study lists 4 primary outcomes in all. 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 6 Dec 2024.