MicrobiomeNCT03450395
The Effect of Oats Containing 1.4g Beta Glucan on Fecal Bacterial Population(s) and Plasma Cholesterol in Healthy Adults With Elevated Cholesterol Levels
A study testing Hot Cereal in people with Microbiome and Plasma Cholesterol, run by PepsiCo Global R&D at 1 site in Ireland.
Trial summary
The objectives of this study are to examine fecal bacterial population(s) and plasma cholesterol levels elicited by 40g of Oats and Cream of Rice over 6 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Microbiome, Plasma Cholesterol, Prebiotic
- What is being tested?
- Hot Cereal
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteIreland
- Study dates
- 28 Jan 2018to 16 Aug 2018
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject has given written informed consent;
- Be between 18 and 65 years of age;
- Has a BMI of between 18.5 - 30 Kg/m2;
- Has a stable body weight (< 5% change) over the past 3-months;
- Have elevated cholesterol levels, with a total cholesterol level >5.5mmol/L and <7mmol/L; and LDL cholesterol level ≥3.4 mmol/L and ≤4.9 mmol/L.
- Is in general good health, as determined by the investigator;
Show all 15Show fewer
- Consumes a low to moderate fiber diet (9.9 - 25.1 g/day in males; 8.2 - 20.3 g/day in females);
- Regularly consumes breakfast;
- Avoid consuming prebiotic, probiotic or fiber rich supplements within 3 weeks prior to baseline visit, until the end of the study;
- Avoid consumption of any whole grain oat products, within 3 weeks prior to baseline visit, until the end of the study;
- Agrees to continue to consume the same dose of vitamin and/or mineral supplements, if applicable, for the duration of the study;
- Maintain current level of physical activity;
- Agree to keep detailed dietary and stool records;
- Willing to consume the investigational products daily for the duration of the study.
- Subject must have access to a microwave oven
Who cannot join
- Females are pregnant, lactating or wish to become pregnant during the study. Female subject is currently either of:
- non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal or any female who is surgically sterilized (via documented hysterectomy or bilateral tubal ligation). (For purposes of this study, postmenopausal is defined as one year without menses), OR
- child bearing potential, the subject is eligible to enter and participate in this study if she is not lactating and has a negative urine pregnancy test at the screening visit, visit 2 and upon completion of the study at visit 7. The subject must also agree to one of the following methods of contraception: i. Complete abstinence from intercourse two weeks prior to administration of study drug, throughout the clinical trial, until the completion of follow-up procedures or for two weeks following discontinuation of the study medication in cases where subject discontinues the study prematurely. (Subjects utilizing this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding 2 weeks when they present to the clinic for the Final Visit.) or, ii. has a male sexual partner who is surgically sterilized prior to the Screen Visit and is the only male sexual partner for that subject or, iii. sexual partner(s) is/are exclusively female or, iv. Oral contraceptives (either combined or progestogen only) with double-barrier method of contraception consisting of spermicide with either condom or diaphragm. (Women of child-bearing potential using an oral contraceptive in combination with a double-barrier method of contraception are required to continue to use this form of contraception for 1 week following discontinuation of study medication).
- Use of double-barrier contraception, specifically, a spermicide plus a mechanical barrier (e.g. male condom, female diaphragm). The subject must be using this method for at least 1 week following the end of the study or, vi. Use of any intrauterine device (IUD) or contraceptive implant with published data showing that the highest expected failure rate is less than 1% per year. The subject must have the device inserted at least 2 weeks prior to the first Screen Visit, throughout the study, and 2 weeks following the end of the study,
- Are hypersensitive to any of the components of the test products;
- Is Coeliac, or has an intolerance to gluten;
Show all 28Show fewer
- Has taken antibiotics within the previous 3 months;
- Has a history of drug and/or alcohol abuse at the time of enrolment;
- Consumes greater than 2 servings/day of alcohol (e.g. >28 g ethanol/day);
- Is a smoker;
- Has a fasting blood glucose level outside the range of 3.0 - 6.0 mmol/L;
- Has uncontrolled hypertension (systolic blood pressure ≥159 mm Hg or diastolic blood pressure ≥99 mm Hg);
- Has made any major dietary changes in the past 3 months;
- Planned major changes in life style (i.e. diet, dieting, exercise level, travelling) during the duration of the study;
- Has a diagnosed eating disorder;
- Is vegetarian/vegan diet or has food allergies or other issues with foods that would preclude intake of the study products;
- Taking a medication/supplement that the investigator believes would impart or treat constipation, including iron, Imodium, Colon Clean, chronic or regular laxatives use or dependency on laxatives; and fiber supplements, within 3 weeks prior to baseline visit, until the end of the study;
- Has an active gastrointestinal disorder or previous gastrointestinal surgery, other than an appendectomy
- If taking chronic medications (e.g., hypertensive medications), they must have been taking the product for at least two months prior to screening and agree to maintain the same dosage throughout the study;
- Subject is on any medication that has an effect on lowering cholesterol, such as use of beta blockers to treat hypertension or anxiety;
- Has a metabolic or gastrointestinal diseases (i.e., diarrhea, Crohn's disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, diabetes, hepatitis, HIV, cancer, etc.), with a history of such diseases;
- Has a condition or taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results; to include Statins (including atorvastatin (Lipitor and Torvast), fluvastatin (Lescol), lovastatin (Mevacor, Altocor, Altoprev), pitavastatin (Livalo, Pitava), pravastatin (Pravachol, Selektine, Lipostat), rosuvastatin (Crestor) and simvastatin (Zocor, Lipex)), Cholesterol Absorption Inhibitors (including Zetia (ezetimibe)), Niacin (nicotinic acid), Fibric acid derivatives (including Atromid-S (clofibrate), Lopid (gemfibrozil), and Tricor (fenofibrate)), Bile Acid Sequestrants (including cholestyramine, sold under the brand names Questran, Prevalite, and LoCholest, and colestipol (Colestid)) and Non Steroidal Anti-Inflammatory Drugs (NSAIDs), or have taken them in the past 28 days;
- Taking a cholesterol lowering supplement, including, example Plant sterols/stanols, Fish Oil supplements, vitamin B supplements (e.g. Niacin and Niacinamide), red rice yeast extract, oat beta glucan, pharmaceutical garlic or have taken them in the past month;
- Are severely immunocompromised (HIV positive, transplant patient, on antirejection medications, on a steroid for >30 days, or chemotherapy or radiotherapy within the last year);
- Experiences alarm features such as weight loss, rectal bleeding, recent change in bowel habit (<3 months) or abdominal pain;
- Have a malignant disease or any concomitant end-stage organ disease;
- Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial;
- Subjects may not be receiving treatment involving experimental drugs. If the subject has been in a recent experimental trial, these must have been completed not less than 60 days prior to this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Oats Containing 1.4g Beta Glucan on Fecal Bacterial Population(s) and Plasma Cholesterol in Healthy Adults With Elevated Cholesterol Levels: a Randomized, Single-blind, Placebo-controlled, Cross-over Study
The objectives of this study are to examine fecal bacterial population(s) and plasma cholesterol levels elicited by 40g of Oats and Cream of Rice over 6 weeks.
- Conditions
- Microbiome, Plasma Cholesterol, Prebiotic
- Being tested
- Hot Cereal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hot CerealOther
Intervention involves consumption of one hot cereal in the beginning of each day
| Study group | Role | What they receive |
|---|---|---|
| Cereal - Cream of Rice | Placebo comparator | 40 g cream of rice Receives: Other: Hot Cereal |
| Cereal - Oats containing beta-glucan | Experimental | 40 g oats Receives: Other: Hot Cereal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal bacterial population(s)
Increase/decrease in desirable fecal bacterial groups (specifically, but not limited to, Bifidobacterium spp. and Lactobacillus/Enterococcus spp.).
Measured: Baseline and Week 6
Secondary outcomes (13)
Fecal Bile Salt Hydrolase
(ng-μg/g)
Measured: Change from baseline and Week 6
Fecal bile acid profile
(ng-μg/g)
Measured: Change from baseline Week 6
Fecal bacterial diversity change
Increase/decrease in desirable fecal bacterial groups (specifically, but not limited to, Bifidobacterium spp. and Lactobacillus/Enterococcus spp.). Increase would be better.
Measured: Change from baseline to Week 6
Serum FGF-19
Fibroblast growth factor (pg/ml)
Measured: Change from baseline to Week 6
Plasma total Cholesterol
mmol/L, lower would be better
Measured: Change from baseline to Week 6
Change in Plasma HDL Cholesterol
mmol/L, higher would be better
Measured: Change from baseline to Week 6
Change in Plasma LDL Cholesterol
mmol/L, lower would be better
Measured: Change from baseline to Week 6
Change in Plasma Triglycerides
mmol/L lower would be better
Measured: Change from baseline to Week 6
Change in Plasma Propionate (propanoic acid)
(µM)
Measured: Change from baseline to Week 6
Stool frequency
Bowel movements recorded in daily diary
Measured: Changes from baseline through 6 weeks
Change in stool consistency
Bristol Stool Scale, for each bowel movement, select closest appearance from chart. 7 types ranging from watery to hard lumps
Measured: Changes from baseline through 6 weeks
Change in gastrointestinal symptoms
Pain, discomfort, bloating \& flatulence recorded using subjective GI symptom ranking questionnaire 6 point scale from none to severe for 4 measures: pain, discomfort, bloating, flatulence. No changes would be better.
Measured: Changes from baseline through 6 weeks
Quality of Life Score
SF-36 questionnaire (SF= Short form)
Measured: Changes from baseline through 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start28 Jan 2018
- Primary completion16 Aug 2018
- Study completion16 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrobiomeStudies 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
- Crossover
- Model description
- For each of the two periods, a hot breakfast cereal will be consumed once daily for a duration of 6 weeks each. There will be a 4 week washout period in between each test substance.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timothy Dinan, MD, PhD, Principal investigator, Cork University Hospital & APC Microbiome Institute, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450395
- Sponsor's protocol ID
- PEP-1720
- Status last verified
- Dec 2019
- First submitted
- 29 Jan 2018
- Last updated
- 5 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oats Containing 1.4g Beta Glucan on Fecal Bacterial Population(s) and Plasma Cholesterol in Healthy Adults With Elevated Cholesterol Levels: a Randomized, Single-blind, Placebo-controlled, Cross-over Study
- ClinicalTrials.gov ID
- NCT03450395
- Acronym / sponsor ID
- PEP-1720
- Conditions
- Microbiome, Plasma Cholesterol, Prebiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 28 Jan 2018 (actual)
- Primary completion
- 16 Aug 2018 (actual)
- Study completion
- 16 Aug 2018 (actual)
- First posted
- 1 Mar 2018 (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 objectives of this study are to examine fecal bacterial population(s) and plasma cholesterol levels elicited by 40g of Oats and Cream of Rice over 6 weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- For each of the two periods, a hot breakfast cereal will be consumed once daily for a duration of 6 weeks each. There will be a 4 week washout period in between each test substance.
| Arm | Type | Receives |
|---|---|---|
| Cereal - Cream of Rice | Placebo comparator | Other: Hot Cereal40 g cream of rice |
| Cereal - Oats containing beta-glucan | Experimental | Other: Hot Cereal40 g oats |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Subject has given written informed consent;
- Be between 18 and 65 years of age;
- Has a BMI of between 18.5 - 30 Kg/m2;
- Has a stable body weight (< 5% change) over the past 3-months;
- Have elevated cholesterol levels, with a total cholesterol level >5.5mmol/L and <7mmol/L; and LDL cholesterol level ≥3.4 mmol/L and ≤4.9 mmol/L.
Key exclusion criteria (28 listed)
- Females are pregnant, lactating or wish to become pregnant during the study. Female subject is currently either of:
- Are hypersensitive to any of the components of the test products;
- Is Coeliac, or has an intolerance to gluten;
- Has taken antibiotics within the previous 3 months;
- Has a history of drug and/or alcohol abuse at the time of enrolment;
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 |
|---|---|---|
| Hot CerealIntervention involves consumption of one hot cereal in the beginning of each day | Other | Cereal - Cream of Rice, Cereal - Oats containing beta-glucan |
Primary outcome
Fecal bacterial population(s)
Time frame: Baseline and Week 6
Increase/decrease in desirable fecal bacterial groups (specifically, but not limited to, Bifidobacterium spp. and Lactobacillus/Enterococcus spp.).
13 secondary outcomes
Fecal Bile Salt Hydrolase
Time frame: Change from baseline and Week 6
Fecal bile acid profile
Time frame: Change from baseline Week 6
Fecal bacterial diversity change
Time frame: Change from baseline to Week 6
Serum FGF-19
Time frame: Change from baseline to Week 6
Plasma total Cholesterol
Time frame: Change from baseline to Week 6
Change in Plasma HDL Cholesterol
Time frame: Change from baseline to Week 6
Change in Plasma LDL Cholesterol
Time frame: Change from baseline to Week 6
Change in Plasma Triglycerides
Time frame: Change from baseline to Week 6
Change in Plasma Propionate (propanoic acid)
Time frame: Change from baseline to Week 6
Stool frequency
Time frame: Changes from baseline through 6 weeks
Change in stool consistency
Time frame: Changes from baseline through 6 weeks
Change in gastrointestinal symptoms
Time frame: Changes from baseline through 6 weeks
Quality of Life Score
Time frame: Changes from baseline through 6 weeks
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 5 Dec 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Microbiome
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Active, not recruiting
SweetSpot - The Effect of Non-nutritive Sweeteners on Health
Healthy Adult
Recruiting
Effect of Anti-inflammatory Diet in Systemic Lupus Erythematous
Systemic Lupus Erthematosus (SLE)
Enrolling by invitation
Dance-Based Exercise for Cancer-Related Fatigue in Breast Cancer Patients
Breast Neoplasms
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.
Timothy Dinan, MD, PhD principal investigator
Cork University Hospital & APC Microbiome Institute, University College Cork
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hot Cereal in people with Microbiome and Plasma Cholesterol, run by PepsiCo Global R&D at 1 site in Ireland.
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 15 inclusion and 28 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 5 Dec 2019. 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 Ireland. 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?
Fecal bacterial population(s) (time frame: Baseline and Week 6). 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 5 Dec 2019.