ObesityKetomaintainNCT04382183
Impact of Ketogenic Diets in Preventing Relapse in Obesity Management
A study testing Ketogenic weight loss maintenance diet and Isocaloric balanced weight loss maintenance diet in people with Obesity, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
Low-carb ketogenic diets have become extremely popular because of large weight loss in the short-term. Yet their potential benefits in preventing long-term weight regain have not been assessed in large scale studies. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Ketogenic weight loss maintenance diet and Isocaloric balanced weight loss maintenance diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteNorway
- Study dates
- 3 Aug 2020to 10 Dec 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- weight stable over the last three months (<2 kg)
- not currently dieting to lose weight
- inactive lifestyle (less than 150 min of physical activity weekly.
- Given that some of the variables of interest have been shown to be affected by the phase of menstrual cycle in normally ovulating women, namely appetite and resting metabolic rate, only women taking oral contraceptives, with regular menstrual cycles or post-menopausal will be included in the study
Who cannot join
- pregnancy
- breast-feeding
- drug or alcohol abuse within the last two years
- clinically significant illness including diabetes, gastrointestinal (particularly cholelithiasis), kidney (GFR <60) or liver disease, osteoporosis (T-score <-2.5) and osteopenia (T-score <-1.5)
- treatment with antiosteoporotic drug
- depression or other psychological disorders
Show all 11Show fewer
- eating disorders
- milk intolerance
- current medication known to affect appetite/metabolism or induce weight loss.
- a planned surgery during the study period
- participating in another research study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy, Feasibility, and Safety of Ketogenic Diets in Preventing Relapse in Obesity Management
Low-carb ketogenic diets have become extremely popular because of large weight loss in the short-term. Yet their potential benefits in preventing long-term weight regain have not been assessed in large scale studies.
The aim of this study is to determine the effect of a low-carbohydrate (CHO) ketogenic diet, compared with an isocaloric balanced diet, on the maintenance of weight loss. The secondary aim is to investigate the impact of both diets on appetite. Adults with obesity (30<BMI<40 kg/m2), will first undergo 4 weeks of a very-low energy diet aimed at inducing 5-10% weight loss and then will be randomized to two different weight maintenance diets for 1 year. One will be a low-CHO ketogenic diet (50 g CHO/day) plant-based (e.g. with less animal protein and more plant-based), and the other a diet following the Norwegian Health Directorate recommendations. Only conventional foods will be used in both diets.
- Conditions
- Obesity
- Being tested
- Ketogenic weight loss maintenance diet, Isocaloric balanced weight loss maintenance diet
- Keywords
- Diet, Ketogenic, Weight Loss, Body Weight
- Medical subject headings
- Obesity, Weight Loss, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic weight loss maintenance dietBehavioural
The ketogenic weight loss maintenance group will undergo in a ketogenic diet (50 g CHO/day) plant-based for 1 year.
Isocaloric balanced weight loss maintenance dietBehavioural
The isocaloric balanced weight loss maintenance group will undergo in a diet following the recommendations from the Norwegian Health Directorate for 1 year.
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic weight loss maintenance diet | Experimental | The ketogenic weight loss maintenance group will undergo in a ketogenic diet (50 g CHO/day) plant-based for 1 year. Receives: Behavioral: Ketogenic weight loss maintenance diet |
| Isocaloric balanced weight loss maintenance diet | Experimental | The isocaloric balanced weight loss maintenance group will undergo in a diet following the standard Norwegian Health Directorate recommendations for 1 year. Receives: Behavioral: Isocaloric balanced weight loss maintenance diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight regain
Body weight will be measured at baseline, at week 5, at 6 months, and at 1 year
Measured: Body weight changes at 1-year intervention
Secondary outcomes (2)
Fasting lipid profile
Blood sampling in fasting to measure lipid profile (plasma concentration of total cholesterol, triglycerides, high-density lipids (HDL), low-density lipids (LDL) at baseline, at 6 months, and at 1 year
Measured: Lipid profile changes at 1-year intervention
Bone mineral density
Bone mineral density will be measured by Dual-energy X-ray absorptiometry (DXA) at baseline, at 6 months, and at 1 year
Measured: Bone mineral density changes at 1-year intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start3 Aug 2020
- Primary completion10 Dec 2021
- Study completion10 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Torstein Baade Rø, MD PhD, Study director, NTNU Faculty of Medicine and Health Sciences, IKOMBirger Henning Endreseth, Professor, Study director, St. Olvas Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04382183
- Sponsor's protocol ID
- 2020/50405
- Acronym
- Ketomaintain
- Status last verified
- Apr 2022
- First submitted
- 28 Apr 2020
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy, Feasibility, and Safety of Ketogenic Diets in Preventing Relapse in Obesity Management
- ClinicalTrials.gov ID
- NCT04382183
- Acronym / sponsor ID
- Ketomaintain / 2020/50405
- Conditions
- Obesity
- Keywords
- Diet, Ketogenic, Weight Loss, Body Weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 11 May 2020 (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.
Low-carb ketogenic diets have become extremely popular because of large weight loss in the short-term. Yet their potential benefits in preventing long-term weight regain have not been assessed in large scale studies.
The aim of this study is to determine the effect of a low-carbohydrate (CHO) ketogenic diet, compared with an isocaloric balanced diet, on the maintenance of weight loss. The secondary aim is to investigate the impact of both diets on appetite. Adults with obesity (30<BMI<40 kg/m2), will first undergo 4 weeks of a very-low energy diet aimed at inducing 5-10% weight loss and then will be randomized to two different weight maintenance diets for 1 year. One will be a low-CHO ketogenic diet (50 g CHO/day) plant-based (e.g. with less animal protein and more plant-based), and the other a diet following the Norwegian Health Directorate recommendations. Only conventional foods will be used in both diets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketogenic weight loss maintenance diet | Experimental | Behavioral: Ketogenic weight loss maintenance dietThe ketogenic weight loss maintenance group will undergo in a ketogenic diet (50 g CHO/day) plant-based for 1 year. |
| Isocaloric balanced weight loss maintenance diet | Experimental | Behavioral: Isocaloric balanced weight loss maintenance dietThe isocaloric balanced weight loss maintenance group will undergo in a diet following the standard Norwegian Health Directorate recommendations for 1 year. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- weight stable over the last three months (<2 kg)
- not currently dieting to lose weight
- inactive lifestyle (less than 150 min of physical activity weekly.
- Given that some of the variables of interest have been shown to be affected by the phase of menstrual cycle in normally ovulating women, namely appetite and resting metabolic rate, only women taking oral contraceptives, with regular menstrual cycles or post-menopausal will be included in the study
Key exclusion criteria (11 listed)
- pregnancy
- breast-feeding
- drug or alcohol abuse within the last two years
- clinically significant illness including diabetes, gastrointestinal (particularly cholelithiasis), kidney (GFR <60) or liver disease, osteoporosis (T-score <-2.5) and osteopenia (T-score <-1.5)
- treatment with antiosteoporotic drug
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 |
|---|---|---|
| Ketogenic weight loss maintenance dietThe ketogenic weight loss maintenance group will undergo in a ketogenic diet (50 g CHO/day) plant-based for 1 year. | Behavioural | Ketogenic weight loss maintenance diet |
| Isocaloric balanced weight loss maintenance dietThe isocaloric balanced weight loss maintenance group will undergo in a diet following the recommendations from the Norwegian Health Directorate for 1 year. | Behavioural | Isocaloric balanced weight loss maintenance diet |
Primary outcome
Body weight regain
Time frame: Body weight changes at 1-year intervention
Body weight will be measured at baseline, at week 5, at 6 months, and at 1 year
2 secondary outcomes
Fasting lipid profile
Time frame: Lipid profile changes at 1-year intervention
Bone mineral density
Time frame: Bone mineral density changes at 1-year intervention
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 Apr 2022.
- Individual participant dataSharing planned: No
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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, MD PhD study director
NTNU Faculty of Medicine and Health Sciences, IKOM
Birger Henning Endreseth, Professor study director
St. Olvas Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketogenic weight loss maintenance diet and Isocaloric balanced weight loss maintenance diet 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 4 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 Apr 2022. 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. 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 regain (time frame: Body weight changes at 1-year intervention). 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 Apr 2022.