ObesityNCT03287726
What is the Impact of Probiotics on Weight Loss Maintenance in Individuals With Obesity?
A study testing probiotics in people with Obesity, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
Weight loss maintenance is the biggest challenge in obesity management, with the majority of weight-reduced individuals experiencing weight regain. The intake of probiotics has been shown to help in weight loss, but its potential in maximizing weight loss maintenance remains unknown. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- probiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteNorway
- Study dates
- 16 Nov 2017to 31 Dec 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- class I or II obesity (30 kg/m2 < BMI > 40 kg/m2)
- weight stable (<2 kg variation in weight within the last 3 months)
- not currently dieting to lose weight
- dietary intervention of 1000 kcal energy restriction for 8 weeks using a powder based low energy diet product, followed by 4 week weight stabilization phase (re-introduction of food)
- women who are either post-menopausal, taking oral contraceptives or with a normal cycle (28 ± 2 days)
Who cannot join
- consumption of probiotics 6 months before taking part in the study
- pregnant
- breast-feeding
- drug or alcohol abuse within the last two years
- currently taking medication known to affect appetite or induce weight loss
- enrolled in another obesity treatment program
Show all 13Show fewer
- history of psychological disorders
- having had bariatric surgery
- metabolic diseases (such as hypo/hyperthyroidism and diabetes type 1 or 2)
- eating disorders
- lactose intolerance
- gastrointestinal (particularly cholelithiasis), kidney, liver, lung, cardiovascular disease
- malignancies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Potential Impact of Probiotics on Weight Loss Maintenance in Individuals With Obesity
Weight loss maintenance is the biggest challenge in obesity management, with the majority of weight-reduced individuals experiencing weight regain. The intake of probiotics has been shown to help in weight loss, but its potential in maximizing weight loss maintenance remains unknown. Therefore, the main aim of this study is to investigate the impact of probiotic consumption on weight loss maintenance. Secondary aims are to investigate if the intake of probiotics influences gut microbiota, cardio-metabolic profile, appetite and inflammatory markers.
- Conditions
- Obesity
- Being tested
- probiotics, placebo
- Keywords
- Probiotics, Appetite Regulation, Gastrointestinal microbiome, Caloric Restriction, Body weight maintenance, Body composition
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probioticsDietary supplement
NYCOPRO, a multistrain probiotic (7 strains of Lactobacilli and Bifidobacteria) sold in the Norwegian pharmacies. 2 capsules/day (one with lunch and one with dinner). 2 text messages daily as a reminder. Follow up meeting at ObeCe (St. Olavs hospital) every month with a research nurse, for weighing, blood pressure measurement and collection of probiotics dose for the following month.
placeboDietary supplement
Placebo 2 capsules/day (one with lunch and one with dinner). 2 text messages daily as a reminder. Follow up meeting at ObeCe (St. Olavs hospital) every month with a research nurse, for weighing, blood pressure measurement and collection of probiotics dose for the following month.
| Study group | Role | What they receive |
|---|---|---|
| probiotics | Experimental | Not described Receives: Dietary Supplement: probiotics |
| placebo | Placebo comparator | Not described Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
body composition
air displacement plethysmography (BodPod, COSMED, Italy)
Measured: 9 months
Secondary outcomes (3)
appetite suppression
Online Visual Analogue Scale (VAS) for the measurement of subjective feelings of appetite (hunger, fullness, desire to eat, prospective consumption)
Measured: 9 months
body composition
Bioelectrical impedance analysis (BIA)
Measured: 9 months
resting metabolic rate
indirect calorimetry
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start16 Nov 2017
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
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 ObesityStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Norwegian University of Life Sciences
- Responsible party
- Sponsor
- Investigators
- Torstein Baade Rø, phd prof, Study chair, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03287726
- Sponsor's protocol ID
- 2016/1297-10
- Status last verified
- Mar 2021
- First submitted
- 14 Sep 2017
- Last updated
- 4 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Martins C, Roekenes J, Salamati S, Gower BA, Hunter GR. Metabolic adaptation is an illusion, only present when participants are in negative energy balance. Am J Clin Nutr. 2020 Nov 11;112(5):1212-1218. doi: 10.1093/ajcn/nqaa220.
PubMed 32844188
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Potential Impact of Probiotics on Weight Loss Maintenance in Individuals With Obesity
- ClinicalTrials.gov ID
- NCT03287726
- Acronym / sponsor ID
- 2016/1297-10
- Conditions
- Obesity
- Keywords
- Probiotics, Appetite Regulation, Gastrointestinal microbiome, Caloric Restriction, Body weight maintenance, Body composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Norwegian University of Life Sciences
- Study start
- 16 Nov 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 19 Sep 2017 (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.
Weight loss maintenance is the biggest challenge in obesity management, with the majority of weight-reduced individuals experiencing weight regain. The intake of probiotics has been shown to help in weight loss, but its potential in maximizing weight loss maintenance remains unknown. Therefore, the main aim of this study is to investigate the impact of probiotic consumption on weight loss maintenance. Secondary aims are to investigate if the intake of probiotics influences gut microbiota, cardio-metabolic profile, appetite and inflammatory markers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| probiotics | Experimental | Dietary Supplement: probiotics |
| placebo | Placebo comparator | Dietary Supplement: placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- class I or II obesity (30 kg/m2 < BMI > 40 kg/m2)
- weight stable (<2 kg variation in weight within the last 3 months)
- not currently dieting to lose weight
- dietary intervention of 1000 kcal energy restriction for 8 weeks using a powder based low energy diet product, followed by 4 week weight stabilization phase (re-introduction of food)
- women who are either post-menopausal, taking oral contraceptives or with a normal cycle (28 ± 2 days)
Key exclusion criteria (13 listed)
- consumption of probiotics 6 months before taking part in the study
- pregnant
- breast-feeding
- drug or alcohol abuse within the last two years
- currently taking medication known to affect appetite or induce weight loss
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 |
|---|---|---|
| probioticsNYCOPRO, a multistrain probiotic (7 strains of Lactobacilli and Bifidobacteria) sold in the Norwegian pharmacies. 2 capsules/day (one with lunch and one with dinner). 2 text messages daily as a reminder. Follow up meeting at ObeCe (St. Olavs hospital) every month with a research nurse, for weighing, blood pressure measurement and collection of probiotics dose for the following month. | Dietary supplement | probiotics |
| placeboPlacebo 2 capsules/day (one with lunch and one with dinner). 2 text messages daily as a reminder. Follow up meeting at ObeCe (St. Olavs hospital) every month with a research nurse, for weighing, blood pressure measurement and collection of probiotics dose for the following month. | Dietary supplement | placebo |
Primary outcome
body composition
Time frame: 9 months
air displacement plethysmography (BodPod, COSMED, Italy)
3 secondary outcomes
appetite suppression
Time frame: 9 months
body composition
Time frame: 9 months
resting metabolic rate
Time frame: 9 months
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 4 Mar 2021.
- Results publication: PubMed 32844188Martins C, Roekenes J, Salamati S, Gower BA, Hunter GR. Metabolic adaptation is an illusion, only present when participants are in negative energy balance. Am J Clin Nutr. 2020 Nov 11;112(5):1212-1218. doi: 10.1093/ajcn/nqaa220.
- Individual participant dataSharing planned: Undecided
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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.
Torstein Baade Rø, phd prof study chair
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing probiotics in people with Obesity, run by Norwegian University of Science and Technology at 1 site in Norway.
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 5 inclusion and 13 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 4 Mar 2021. 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 Norway. 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 composition (time frame: 9 months). 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 NCT03287726, 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 4 Mar 2021.