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Metabolic SyndromeNCT04128839

Impacts of Aronia on Inflammation and the Gut Microbiome

A study testing Aronia berry juice in people with Metabolic Syndrome and Inflammation, run by Montana State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The overall goal of this project is to determine the inflammation lowering impact of anthocyanin-rich Aronia berries. Inflammation is an underlying mechanism driving the development of several diseases. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
What is being tested?
Aronia berry juice
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteUnited States
Study dates
27 Apr 2019to 27 Dec 2021
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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • BMI 28-35 kg/m^2

Who cannot join

  • Antibiotics up to 90 days prior to enrollment
  • Anti-inflammatory medications
  • Allergy or intolerance to wheat or dairy
  • Hormone-based birth control (with exception of intrauterine device)
  • Pregnant
  • Heart disease
  • Other health conditions or concerns that may interfere with study participation

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Montana State University

    Bozeman, Montana, 59717

Other trials in United States

About this study

Official title: Determining the Gut Microbiota-dependent Impacts of Anthocyanin-rich Aronia Berries on Obese Individuals of Distinct Inflammatory Phenotypes

The overall goal of this project is to determine the inflammation lowering impact of anthocyanin-rich Aronia berries. Inflammation is an underlying mechanism driving the development of several diseases. While an elevation in immune signals in the systemic circulation is commonly attributed to adipose tissue, inflammation is not present in all obese individuals. Adipose tissue must become inflamed, and the inflammation trigger may come from other sources. Microorganisms (microbiome), host tissues, and immune cells residing in the gastrointestinal tract (GIT) are a key source of pro-inflammatory signals that may cause the host organism to become inflamed. Anthocyanins are bioactive compounds with established anti-inflammatory and microbiome altering properties. We hypothesize that the GIT microbiome is a key determinant of host inflammation than can be manipulated by anthocyanins-rich berries to lower inflammation. We assembled a cohort of individuals, characterized their GIT microbiome and performed anthropometric measurements, basal measures of metabolism and metabolic health, and triglyceridemic, metabolomic, and inflammation responses to a high-fat meal challenge.

Read the detailed description

Anthropometrics. Measurements were collected from participants using the validated segmental multifrequency bioelectrical impedance analysis (SECA mBCA 515, Hamburg, Germany). Fat mass (%) and estimated visceral adipose (L) were used for analysis.

High-Fat Meal Challenge. The high-fat meal contained salted butter (58.3 g, Tillamook) over 3 pieces of whole wheat toast (127.5 g; Wheat Montana). Total energy content of the meal was 714 kcal, with 43.1% from fat, with a macronutrient breakdown of 50 g fat, 54 g carbohydrate, and 12 g protein. Water was provided with the meal; caffeinated black tea was provided instead for participants who identified as habitual coffee consumers.

Blood Sampling. Participants were instructed to avoid alcohol consumption and strenuous physical activity in the 24 hours before their visit and to complete an overnight fast (10 - 12 hours) before blood collection. Participant blood samples were collected by a certified nurse or physician in the morning before ingestion of the meal and hourly for 4 hours after meal ingestion, totaling five time points. Whole blood in serum separating tubes was allowed to clot for 15 minutes before centrifugation at 1200 RPM for 15 minutes with resulting serum aliquoted and stored at -80ºC until analysis.

Determination of blood markers. Blood markers of metabolic syndrome were determined from whole blood run on Picollo Xpress Chemistry Analyzer lipid panels (Abaxis, Union City, USA). Serum insulin (INS) was determined using an insulin ELISA kit (MP Biomedicals, Solon, OH) performed according to manufacturer instructions. Cytokine measurement was performed using high-sensitivity multiplexing technology (Bio-Rad Bio-Plex 200 HTS) following procedures by Millipore (EMD Millipore Corporation, Billerica, USA). Classic systemic pro-inflammatory cytokines were measured and include granulocyte macrophage colony stimulating factor (GM-CSF), interleukin (IL)-1B, IL-6, tumor necrosis factor (TNF)-α. InterleukinI-17 and IL-23, both of which serve a pro-inflammatory and regulatory role in the gut mucosa, were also measured. Serum samples at each time point during the high-fat meal challenge were run in duplicate.

Stool Sample Collection. Collection kits were provided and participants were asked to follow included instructions for the self-collection of a stool sample in the 24 hours before their blood collection visit. After initial collection into a sterile disposable commode, a small portion of the sample was transferred into a sterile Eppendorf tube and transported to researchers. Samples were prepared and aliquoted in an anaerobic chamber then frozen at -80ºC until analysis.

Genomic DNA Extraction and Microbial Analysis. Extraction of bulk DNA from fecal samples was performed using Powersoil DNA Isolation Kit (Mo Bio Laboratories, Inc.) and bead beating. DNA was shipped overnight to the University of Michigan, Michigan Microbiome Project for Illumina MiSeq amplicon sequencing of the 16S rRNA V4 region. After DNA quantification, V4 amplicon libraries were generated with dual-index barcoded primers, then by library purification, pooling, and MiSeq paired-end sequencing. Raw sequencing reads were processed and curated using MOTHUR software (Version 1.35.1) following the MOTHUR standard operating procedure for the MiSeq platform39. In brief review, paired-end reads were assembled into contiguous sequences and screened for length and quality. The remaining contigs were aligned to the SILVA ribosomal RNA database (Release 132), a comprehensive collection of aligned rRNA sequences. Potentially chimeric sequences were identified and removed using the UCHIME algorithm in MOTHUR. Taxonomic classifications were assigned using the Bayesian classifier of the Ribosomal Database Project. Non-target reads were removed, and operational taxonomic units (OTUs) were assigned using VSEARCH distance-based clustering at the 97% similarity threshold. Alpha-, and β- diversity indices were generated using the vegan package in R40. An OTU-based data matrix was constructed for participants included in the ppTG phenotype.

Metabolomic Analysis. Frozen serum samples were thawed and 20μL was placed in a clean tube. 80μL of HPLC grade methanol was added to the sample after which it was vortexed briefly and placed in a -80 C freezer for 2 hours. After two hours, the sample was centrifuged at 20,000g for 10 minutes. The metabolite supernatant was collected and concentrated in a Speed Vac to dryness while the protein pellet was discarded. Samples were then stored at -80 C until ready for LCMS analysis at which time they were reconstituted with 40μL of methanol:water (50:50) and placed in a clean mass spectrometry vial. Analysis was completed on an Agilent 6538 Q-TOF MS coupled to an Agilent 1290 UHPLC using a 130A, 1.7μm, 2.1mm X 10mm Acquity BEH-HILIC HPLC column. Samples were ionized via electrospray ionization and runs were completed in positive mode. Mobile phase A was 15mmol/L ammonium formate and mobile phase B was ACN using a 10-40% A gradient over 6 minutes. Flow was kept at 400µL/minute and the column compartment temperature was set at 30 C. MSMS analysis was completed using the same LC conditions while targeting specific ions using retention time and m/z values from previous MS runs. After LCMS analysis completion, raw data files were converted to .xml files using MSConvert. Data was then mined with mzMine using an intensity minimum value of 1,000 based on a visual inspection of the total ion chromatogram to remove noise. Blank samples were also ran and the resulting features were removed from the biological data if present at a ratio under 5:1 in the sample compared to the blank. Mined data was then input into MetaboAnalyst for statistical analysis. Tandem MS data was analyzed with Sirius software to identify features.

Being tested
Aronia berry juice, Sham comparator
Keywords
gut microbiome, metabolome, postprandial hypertriglyceridemia, low-grade inflammation, visceral adipose tissue
Medical subject headings
Metabolic Syndrome, Inflammation, Hypertriglyceridemia, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aronia berry juiceDietary supplement

    A juice blend of three different cultivars was used: Viking, MacKenzie and Autumn Magic. Raw juice was heat pasteurized before provided to participants. Participants consumed 100 mL of juice per day.

  • Sham comparatorOther

    The placebo was flavor, color, and carbohydrate-matched to aronia juice. The placebo consisted of 28.8 g black cherry Koolaid mix (no sugar added), 128.5 g sorbitol, 74.5 g glucose, 77.9 g fructose, 4 oz lemon juice, 16 drops of blue food coloring, and enough water to create 1 L of solution. Participants consumed 100 mL of juice per day.

Study groups in NCT04128839
Study groupRoleWhat they receive
Aronia juice (ARO)ExperimentalA juice blend of three different cultivars was used: Viking, MacKenzie and Autumn Magic. Raw juice was heat pasteurized before provided to participants. Participants consumed 100 mL of juice per day for duration of intervention period (28-30 days)
Receives: Dietary Supplement: Aronia berry juice
Placebo juice (PLA)Sham comparatorThe placebo juice was flavor, color, and carbohydrate-matched to experimental Aronia juice. PLA consisted of 28.8 g black cherry Koolaid mix (no sugar added), 128.5 g sorbitol, 74.5 g glucose, 77.9 g fructose, 4 oz lemon juice, 16 drops of blue food coloring, and enough water to create 1 L of solution. Participants consumed 100 mL of juice per day for duration of intervention period (28-30 days)
Receives: Other: Sham comparator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Inflammation state

    Serum levels of a eight cytokine panel: interleukin (IL)-1B, IL-6, IL-10, IL-17, IL-23, tumor necrosis factor-alpha (TNF-a), granulocyte macrophage-colony stimulating factor (GM-CSF), interferon gamma (IFNy)

    Measured: 1 day

  2. Gut microbiome

    Taxonomic composition of the gut microbiome measured from 16s rRNA sequencing of stool samples

    Measured: 1 day

  3. Gut Metabolome

    Stool sample metabolome

    Measured: 1 day

  4. Postprandial TG Response to a High-fat Meal Challenge

    TG concentrations before, 1, 2, 4, and 6 hours following consumption of a meal containing 50 g of fat (toast with butter)

    Measured: 1 day

  5. Postprandial Inflammation Response to a High-fat Meal Challenge

    Cytokine panel (IL-1B, IL-6, IL-10, IL-17, IL-23, TNF-a, GM-CSF, and IFNy) before, 1, 2, 4, and 6 hours following consumption of a meal containing 50 g of fat (toast with butter)

    Measured: 1 day

  6. Postprandial Metabolomic Response to a High-fat Meal Challenge

    Serum metabolome before, 1, 2, 4, and 6 hours following consumption of a meal containing 50 g of fat (toast with butter)

    Measured: 1 day

  7. Glycemic control

    Hemoglobin A1c (% glycosylation)

    Measured: 1 day

  8. Fasting glucose

    Fasting serum glucose (mM)

    Measured: 1 day

  9. Fasting insulin

    Fasting serum insulin (pmol/l)

    Measured: 1 day

  10. Lipid panel

    Fasting serum TG, LDL, HDL, and total cholesterol

    Measured: 1 day

  11. Fasting metabolites

    Serum metabolome measured after an overnight fast

    Measured: 1 day

  12. Self-reported physical activity

    Self report of the number of days each week in which aerobic, strength, and stretching type exercises are performed

    Measured: 1 day

  13. Blood pressure

    Resting systolic and diastolic blood pressure (mmHg)

    Measured: 1 day

  14. Body composition

    Body composition (% fat, %lean)

    Measured: 1 day

  15. Height

    Height (m)

    Measured: 1 day

  16. Weight

    Weight (kg)

    Measured: 1 day

  17. Waist circumference

    Waist circumference (cm)

    Measured: 1 day

  18. Visceral adipose tissue

    Volume of visceral adipose tissue (l)

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2019
  2. Study start27 Apr 2019
  3. Primary completion30 Sep 2019
  4. Study completion27 Dec 2021

Resources

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
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04128839
Sponsor's protocol ID
USDA-NIFA 2017-67018-26367
Status last verified
Jan 2024
First submitted
14 Oct 2019
Last updated
16 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wilson SM, Maes AP, Yeoman CJ, Walk ST, Miles MP. Determinants of the postprandial triglyceride response to a high-fat meal in healthy overweight and obese adults. Lipids Health Dis. 2021 Sep 20;20(1):107. doi: 10.1186/s12944-021-01543-4.

    PubMed 34544430

Questions about this trial

What is this clinical trial studying?

A study testing Aronia berry juice in people with Metabolic Syndrome and Inflammation, run by Montana State University 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 1 inclusion and 7 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 16 Jan 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?

Inflammation state (time frame: 1 day). The study lists 18 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 NCT04128839, 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 16 Jan 2024.

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