Randomized Versus PlaceboNCT02228746
Effect of the Alpha-galacto-oligasaccharides on Weight Loss in Overweight or Moderately Obeses Adults : A Randomized Controlled Double Blinded Trial Versus Placebo
A study testing Alpha-galacto-oligosaccharides in people with Randomized Versus Placebo and Controlled, run by Olygose at 1 site in France.
Trial summary
Clinical intervention on overweight or moderately obeses adults. The objective of this trial is to demonstrate the superior eficacy of Alphagos to placebo on weight loss during a low-calorie diet of 12 weeks. The superiority is judged on body weight. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Randomized Versus Placebo, Controlled, Double Blind
- What is being tested?
- Alpha-galacto-oligosaccharides
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2013to Aug 2014
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body Mass Index > or equal 25 and < 35
- Use of effective contraception in women of childbearing age
Who cannot join
- Pregnant women (positive pregnancy test) or breastfeeding
- Anti-hypertensive or cholesterol treatment
- HIV infection or HCV
- Hepatic and/or severe renal failure
- Heart attack within 6 months prior the selection
- Heart failure known
Show all 11Show fewer
- Inflammatory disease known
- Cancer or have had cancer within 3 years prior to the study except for basal cell skin cancers
- Diabetes defined by blood glucose greater than or equal to 1.26 g/L
- Gastrointestinal disease known
- Bariatric surgery
Trial locations and contacts
1 site in 1 country.
France1 site
Centre d'Investigation Clinique Paris-Est/ Bâtiment Antonin Gosset Hôpital de la Pitié Salpêtrière- 56 Boulevard Vincent Auriol
Paris, 75013
About this study
Clinical intervention on overweight or moderately obeses adults. The objective of this trial is to demonstrate the superior eficacy of Alphagos to placebo on weight loss during a low-calorie diet of 12 weeks. The superiority is judged on body weight. Change in cardiometabolic risk factors through the intervention have been evaluated as secondary endpoints
- Conditions
- Randomized Versus Placebo, Controlled, Double Blind
- Being tested
- Alpha-galacto-oligosaccharides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha-galacto-oligosaccharidesDietary supplement
6g of alpha-galacto-oligosaccharides in a 100 mL flavored drink
| Study group | Role | What they receive |
|---|---|---|
| Alpha-galacto-oliosaccharides | Experimental | Not described Receives: Dietary Supplement: Alpha-galacto-oligosaccharides |
| Placebo | Placebo comparator | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight (kg) between day 0 and week 12
Measured: Day 0, Day 7, Month 1, Month 2, Month 3
Secondary outcomes (6)
Feeding behaviour
Changes in feeding behaviour will be studied by :
- visual analogue scales rating for hunger, satiety, fullness, desire to eat, prospective consumption during preload-test meal paradigm (standardized breakfast and lunch test)
- level of circulating peptides involved in the regulation of controlling food intake during a kinetic after a standardized breakfast (samples 30, 60, 120, 180 and 240 min after the start of standardized breakfast)
- food intake during the lunch test
Measured: Between day 0 and week 12
Lean body mass
Measured: Between day 0 and week 12
Waist circumference
Measured: Day 0, day 7, Month1, Month 2, Month 3
Hip circumference
Measured: Day 0, Day 7, Month 1, Month 2, Month 3
Waist to hip circumference ratio
Measured: Between Day 0 and week 12
Body Fat
Measured: Day 7, Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2014 (estimated)
- Study startSep 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Randomized Versus PlaceboStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olygose
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institute of Cardiometabolism and Nutrition, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02228746
- Sponsor's protocol ID
- 2012-A01610--43
- Status last verified
- Aug 2014
- First submitted
- 28 Apr 2014
- Last updated
- 29 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Alpha-galacto-oligasaccharides on Weight Loss in Overweight or Moderately Obeses Adults : A Randomized Controlled Double Blinded Trial Versus Placebo
- ClinicalTrials.gov ID
- NCT02228746
- Acronym / sponsor ID
- 2012-A01610--43
- Conditions
- Randomized Versus Placebo, Controlled, Double Blind
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- OlygoseIndustry (pharma, biotech, devices)
- Collaborators
- Institute of Cardiometabolism and Nutrition, France
- Study start
- Sep 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 29 Aug 2014 (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.
Clinical intervention on overweight or moderately obeses adults. The objective of this trial is to demonstrate the superior eficacy of Alphagos to placebo on weight loss during a low-calorie diet of 12 weeks. The superiority is judged on body weight. Change in cardiometabolic risk factors through the intervention have been evaluated as secondary endpoints
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alpha-galacto-oliosaccharides | Experimental | Dietary Supplement: Alpha-galacto-oligosaccharides |
| Placebo | Placebo comparator | – |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body Mass Index > or equal 25 and < 35
- Use of effective contraception in women of childbearing age
Key exclusion criteria (11 listed)
- Pregnant women (positive pregnancy test) or breastfeeding
- Anti-hypertensive or cholesterol treatment
- HIV infection or HCV
- Hepatic and/or severe renal failure
- Heart attack within 6 months prior the 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 |
|---|---|---|
| Alpha-galacto-oligosaccharides6g of alpha-galacto-oligosaccharides in a 100 mL flavored drink | Dietary supplement | Alpha-galacto-oliosaccharides |
Primary outcome
Body weight (kg) between day 0 and week 12
Time frame: Day 0, Day 7, Month 1, Month 2, Month 3
6 secondary outcomes
Feeding behaviour
Time frame: Between day 0 and week 12
Lean body mass
Time frame: Between day 0 and week 12
Waist circumference
Time frame: Day 0, day 7, Month1, Month 2, Month 3
Hip circumference
Time frame: Day 0, Day 7, Month 1, Month 2, Month 3
Waist to hip circumference ratio
Time frame: Between Day 0 and week 12
Body Fat
Time frame: Day 7, Month 3
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 29 Aug 2014.
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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 Alpha-galacto-oligosaccharides in people with Randomized Versus Placebo and Controlled, run by Olygose at 1 site in France.
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 2 inclusion and 11 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 29 Aug 2014. 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 France. 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?
Body weight (kg) between day 0 and week 12 (time frame: Day 0, Day 7, Month 1, Month 2, Month 3). 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 29 Aug 2014.