Mildly Hypercholesterolemic SubjectsNCT02376660

Effect of Oats on Lipid Profile

A study testing Oats in people with Mildly Hypercholesterolemic Subjects, run by PepsiCo Global R&D.

Completed

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

Trial summary

A randomized control trial to assess the effect of oats on lipid profile of mildly hypercholesterolemic subjects. Subjects consumed 35g of oats twice daily (total of 70g / day) in place of carbohydrates as part of their usual diet. 70 grams of oats provide 3 grams of soluble fiber. Read more about this study

Who is it for?: Ages 20 to 50 years
Conditions the study is for: Mildly Hypercholesterolemic Subjects
What is being tested?: Oats
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: No sites listed yet
Study dates: Dec 2012to Aug 2013
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 20 to 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Men and women between 20 and 50 years old
Total Cholesterol: ≥ 200 mg/dL and < 240mg/dL
Availability and willingness to follow study protocol
Stable body weight for previous 3 months (not more than 5% weight change)

Who cannot join

Subjects already on lipid lowering drugs
LDL-c > 190 mg/dL
Total cholesterol <200 mg/dL and >240 mg/dL
Subjects with serum creatinine levels > 1.3 mg/dL (female) or 1.4 mg/dL (male), nephropathy, evidence of hepatic disease or history of alcohol abuse
Baseline Triglycerides: > 300 mg/dL
Diabetes (Type 1 or Type 2) as diagnosed by a physician

Show all 15Show fewer

Uncontrolled hyperthyroidism (as per physician's discretion)
Uncontrolled hypertension (as per physician's discretion)
Acute infections or chronic debilitating diseases like tuberculosis, malignancy, HIV infection etc. Any life threatening serious disorder of the liver, kidneys, heart, lungs or other organs by history
Irritable bowel syndrome by history
Unwillingness to give written informed consent for participation in the study.
Pregnancy \& lactation (by history)
Severe end organ damage
Subjects with allergy to oats
Heavy smokers (smoking more than 5 cigarettes per day)

About this study

Official title: A Randomized Controlled Trial to Evaluate the Efficacy of 3 g of Soluble Fiber From Oats on the Lipid Profile of Men and Women With Elevated Lipid Levels Aged Between 20 and 50 Years

Conditions: Mildly Hypercholesterolemic Subjects
Being tested: Oats

What participants receive

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

OatsOther

Study groups in NCT02376660
Study group	Role	What they receive
Oats	Experimental	70 grams oats Receives: Other: Oats
usual diet and exercise	Placebo comparator	usual diet and exercise

What is being measured

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

reduction of total cholesterol
Measured: 4 weeks

Secondary outcomes (3)

LDL-c
Measured: 4 weeks
Triglycerides
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.

Dec 2012Aug 2013

First posted3 Mar 2015 (estimated)
Study startDec 2012
Primary completionAug 2013
Study completionAug 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Mildly Hypercholesterolemic SubjectsStudies 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: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02376660
Sponsor's protocol ID: PEP-1205
Status last verified: Feb 2015
First submitted: 25 Feb 2015
Last updated: 3 Mar 2015
Results posted: No
Data monitoring committee: No

Publications

Gulati S, Misra A, Pandey RM. Effects of 3 g of soluble fiber from oats on lipid levels of Asian Indians - a randomized controlled, parallel arm study. Lipids Health Dis. 2017 Apr 4;16(1):71. doi: 10.1186/s12944-017-0460-3.
PubMed 28376899

Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Trial to Evaluate the Efficacy of 3 g of Soluble Fiber From Oats on the Lipid Profile of Men and Women With Elevated Lipid Levels Aged Between 20 and 50 Years
ClinicalTrials.gov ID: NCT02376660
Acronym / sponsor ID: PEP-1205
Conditions: Mildly Hypercholesterolemic Subjects
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: PepsiCo Global R&DIndustry (pharma, biotech, devices)
Study start: Dec 2012
Primary completion: Aug 2013 (actual)
Study completion: Aug 2013 (actual)
First posted: 3 Mar 2015 (estimated)
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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Oats	Experimental	Other: Oats70 grams oats
usual diet and exercise	Placebo comparator	–usual diet and exercise

Who may qualify

Ages: 20 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Men and women between 20 and 50 years old
Total Cholesterol: ≥ 200 mg/dL and < 240mg/dL
Availability and willingness to follow study protocol
Stable body weight for previous 3 months (not more than 5% weight change)

Key exclusion criteria (15 listed)

Subjects already on lipid lowering drugs
LDL-c > 190 mg/dL
Total cholesterol <200 mg/dL and >240 mg/dL
Subjects with serum creatinine levels > 1.3 mg/dL (female) or 1.4 mg/dL (male), nephropathy, evidence of hepatic disease or history of alcohol abuse
Baseline Triglycerides: > 300 mg/dL

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
Oats	Other	Oats

Primary outcome

reduction of total cholesterol
Time frame: 4 weeks

3 secondary outcomes

LDL-c
Time frame: 4 weeks
Triglycerides
Time frame: 4 weeks
Blood pressure
Time frame: 4 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 3 Mar 2015.
Derived from this study: PubMed 28376899Gulati S, Misra A, Pandey RM. Effects of 3 g of soluble fiber from oats on lipid levels of Asian Indians - a randomized controlled, parallel arm study. Lipids Health Dis. 2017 Apr 4;16(1):71. doi: 10.1186/s12944-017-0460-3.

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.

Anoop Misra, MD, MBBS principal investigator

Fortis Clinical Research Limited

Questions about this trial

What is this clinical trial studying?

A study testing Oats in people with Mildly Hypercholesterolemic Subjects, run by PepsiCo Global R&D.

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 15 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 3 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

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?

reduction of total cholesterol (time frame: 4 weeks). 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 NCT02376660, 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 3 Mar 2015.