The Effect of Oats Containing 1.4g Beta Glucan on Fecal Bacterial Population(s) and Plasma Cholesterol in Healthy Adults With Elevated Cholesterol Levels

NCT03450395 | Completed

• 1 other identifier: PEP-1720
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Microbiome; Plasma Cholesterol; Prebiotic

Outcome Measures

Primary Outcomes (1)

• Fecal bacterial population(s)

  Increase/decrease in desirable fecal bacterial groups (specifically, but not limited to, Bifidobacterium spp. and Lactobacillus/Enterococcus spp.).

  Baseline and Week 6

Secondary Outcomes (13)

• Fecal Bile Salt Hydrolase

  Change from baseline and Week 6

• Fecal bile acid profile

  Change from baseline Week 6

• Fecal bacterial diversity change

  Change from baseline to Week 6

• Serum FGF-19

  Change from baseline to Week 6

• Plasma total Cholesterol

  Change from baseline to Week 6

Study Arms (2)

Cereal - Cream of Rice

PLACEBO COMPARATOR

40 g cream of rice

Other: Hot Cereal

Cereal - Oats containing beta-glucan

EXPERIMENTAL

40 g oats

Other: Hot Cereal

Interventions

Hot Cereal OTHER

Intervention involves consumption of one hot cereal in the beginning of each day

Cereal - Cream of Rice; Cereal - Oats containing beta-glucan

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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

You may not qualify if:

• 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).
• v. 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;
• 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;

Sponsors & Collaborators

• PepsiCo Global R&D: lead

Study Sites (1)

Atlantia Food Clinical Trials

Cork, T12 H2TK, Ireland

Location

Study Officials

• Timothy Dinan, MD, PhD

  Cork University Hospital & APC Microbiome Institute, University College Cork

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: March 1, 2018
• Study Start: January 28, 2018
• Primary Completion: August 16, 2018
• Study Completion: August 16, 2018
• Last Updated: December 5, 2019

Record last verified: 2019-12

Locations

IE (1)