Mildly Hypercholesterolemic SubjectsNCT01571869
Pilot Study in the Cholesterol Absorption Reduction After Consumption of Low-fat, Drinkable Fermented Milk Enriched With Plant Sterols
A study testing 1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unit in people with Mildly Hypercholesterolemic Subjects, run by Danone Global Research & Innovation Center at 1 site in Canada.
Trial summary
The objective of this study is to compare efficacy of a plant sterol enriched yogurt given at different moments of the day in lowering blood cholesterol of hypercholesterolemic. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Mildly Hypercholesterolemic Subjects
- What is being tested?
- 1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unit
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2005to Apr 2006
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male and post-menopausal female aged 40-80 years;
- BMI between 22 and 32 kg/m2,
- Non-smoker, Stabilized LDL-c over 3.0 mmol/L,
- Not taking any medication known to affect lipid metabolism for at least the previous 3 month period,
- Agree to follow the dietary recommendations in the context of their hypercholesterolemia,
- Have to give written consent to take part in the study
Who cannot join
- Thyroid disease, diabetes mellitus, kidney disease or liver disease, Hypertension (95<SBP>140 mmHg and/or 45<DBP>90 mmHg),
- Previous history of symptomatic vascular disease, TG level > 2,8 g/l,
- History of metabolic or gastrointestinal disease with the exception of appendicectomy,
- Consumption of large amounts of alcohol,
- Having undergone general anesthesia in the month prior to pre-selection,
- Receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters,
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- Having serious or acute disease likely to influence study results or involved in life time,
- Presenting allergy or hypersensitivity to milk proteins, or refusing to consume them,
- Refusing to stop his/her consumption of enriched plant sterol trade products during the study,
- In a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject,
- For female subjects: likely to change her hormonal substitutive treatment,
- Currently in an exclusion period following participation in another clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of a Meal on the Efficacy of Plant Sterol Given at Different Times of the Day in Management of Hypercholesterolemia
The objective of this study is to compare efficacy of a plant sterol enriched yogurt given at different moments of the day in lowering blood cholesterol of hypercholesterolemic.
- Conditions
- Mildly Hypercholesterolemic Subjects
- Being tested
- 1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unit, 2- Low fat drinkable fermented dairy product without plant sterols (control)
- Keywords
- Plant sterol - hypercholesterolemia - dairy - meal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unitOther
1-Intervention with test product (morning, evening or snack)
2- Low fat drinkable fermented dairy product without plant sterols (control)Other
2 - Intervention with control product (morning and/or evening)
| Study group | Role | What they receive |
|---|---|---|
| 1 = Tested product | Experimental | Not described Receives: Other: 1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unit |
| 2 = Control product | Placebo comparator | Not described Receives: Other: 2- Low fat drinkable fermented dairy product without plant sterols (control) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2012 (estimated)
- Study startApr 2005
- Primary completionDec 2005
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Global Research & Innovation Center
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01571869
- Sponsor's protocol ID
- NU142
- Status last verified
- Dec 2016
- First submitted
- 3 Apr 2012
- Last updated
- 7 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of a Meal on the Efficacy of Plant Sterol Given at Different Times of the Day in Management of Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT01571869
- Acronym / sponsor ID
- NU142
- Conditions
- Mildly Hypercholesterolemic Subjects
- Keywords
- Plant sterol - hypercholesterolemia - dairy - meal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Danone Global Research & Innovation CenterIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Dec 2005 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 5 Apr 2012 (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.
The objective of this study is to compare efficacy of a plant sterol enriched yogurt given at different moments of the day in lowering blood cholesterol of hypercholesterolemic.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 = Tested product | Experimental | Other: 1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unit |
| 2 = Control product | Placebo comparator | Other: 2- Low fat drinkable fermented dairy product without plant sterols (control) |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- male and post-menopausal female aged 40-80 years;
- BMI between 22 and 32 kg/m2,
- Non-smoker, Stabilized LDL-c over 3.0 mmol/L,
- Not taking any medication known to affect lipid metabolism for at least the previous 3 month period,
- Agree to follow the dietary recommendations in the context of their hypercholesterolemia,
Key exclusion criteria (12 listed)
- Thyroid disease, diabetes mellitus, kidney disease or liver disease, Hypertension (95<SBP>140 mmHg and/or 45<DBP>90 mmHg),
- Previous history of symptomatic vascular disease, TG level > 2,8 g/l,
- History of metabolic or gastrointestinal disease with the exception of appendicectomy,
- Consumption of large amounts of alcohol,
- Having undergone general anesthesia in the month prior to pre-selection,
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 |
|---|---|---|
| 1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unit1-Intervention with test product (morning, evening or snack) | Other | 1 = Tested product |
| 2- Low fat drinkable fermented dairy product without plant sterols (control)2 - Intervention with control product (morning and/or evening) | Other | 2 = Control product |
Primary outcome
Not reported in the source record.
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 7 Dec 2016.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unit in people with Mildly Hypercholesterolemic Subjects, run by Danone Global Research & Innovation Center at 1 site in Canada.
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 6 inclusion and 12 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 7 Dec 2016. 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 Canada. 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.
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 7 Dec 2016.