Type 1 DiabetesNCT05872711
Low Carbohydrate Versus Mediterranean Diet in Adolescents With Type 1 Diabetes
A study testing Low carbohydrate diet in people with Type 1 Diabetes, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The goal of this clinical trial is to compare the effect of low carbohydrate diet versus Mediterranean diet on blood sugar values in adolescents with type 1 diabetes. The main question aims to answer whether a low carbohydrate diet is as effective as the Mediterranean diet for better glycaemic control in type 1… Read more about this study
- Who is it for?
- Ages 12 to 22 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Low carbohydrate diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- 19 Apr 2023to 1 Aug 2025
- 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 12 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Type 1 diabetes
- Connected to a continuous glucose monitoring (CGM)
Who cannot join
- History of eating disorder
- Family history of mental disorders
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba_Medical_Center
Ramat Gan, 52621
Orit p Hamiel, prof MD, +97235305015, orit.hamiel@sheba.health.gov.il
Elinor Mauda, BA, +97235305015, elinor.mauda@sheba.health.gov.il
About this study
Official title: Low Carbohydrate Versus Mediterranean Diet in Adolescents With Type 1 Diabetes: A Randomized Control Trial
The goal of this clinical trial is to compare the effect of low carbohydrate diet versus Mediterranean diet on blood sugar values in adolescents with type 1 diabetes.
The main question aims to answer whether a low carbohydrate diet is as effective as the Mediterranean diet for better glycaemic control in type 1 adolescents.
Read more
The investigators are also aiming to check whether low carbohydrate diet is safe and does not elevate cholesterol blood levels and whether the diet is adherable among youth with type 1 diabetes.
Participants with type 1 diabetes wearing a continuous glucose monitor and that will sign an informed consent will be randomly selected for 2 groups. One group will get the Mediterranean diet program and the other will get the low carbohydrate diet program, both for a duration of six months. Each participant will attend a cooking workshop at the beginning of the study. Blood work and stool samples will be taken at the beginning and 3 times through the study periodd. Each participant will attend meetings with the dietician thorough the period of the study.
Read the detailed description
Background and objective: Improved glycemic control of type 1 diabetes (T1DM), with low rates of adverse events was reported via an online community of children and adults who consume a of low carbohydrate diet (LCD). The investigators aim to compare the effects of a low carbohydrate diet (LCD) with those of a Mediterranean diet on glycemic control, lipid profile, bone metabolites and the microbiome profile in adolescents with type 1 diabetes.
Design A randomized, controlled trail. Families of adolescents in the Diabetes clinic in Edmond and Lily Safra Children's Hospital will be approached and offered to participate in a dietary intervention study. After participants will sign the informed consent, they will randomly be assigned into 2 diet treatment groups, the LCD (n=20) and the Mediterranean diet (n=20). Baseline nutrition teaching session and training and will be conducted for all participants and their parents. Participants will attend visit with the dietician at baseline, 2, 4, 8,12 weeks and will be given a 3-day food dairy to complete twice in that period. Measurements of weight, height, blood pressure, HbA1c, Time in range, number of hypoglycemia, lipid profile, creatinine, bone metabolites will be measured at baseline and 12 and 24 weeks and gut bacteria profile at baseline and at 24 weeks. Personality, quality of life, and socioeconomic questionnaires will be given to children and their parents.
Contribution of the suggested research:
In this research the investigators are aiming to show that LCD is as good as Mediterranean diet with improved glycemic control, safe, and adherable for adolescent with T1D.
- Conditions
- Type 1 Diabetes
- Being tested
- Low carbohydrate diet
- Keywords
- Adolescents, Glycemic targets, Low carbohydrate diet, Mediterranean diet
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low carbohydrate dietOther
In order to maintain equal intensity of treatment, each patient will get a cooking workshop and received a personalized diet regime at baseline, based on the randomly assigned diet. Format and quality of the materials are similar.
All diet plans are individualized and matched for energy intake personally . Participants will meet individually with the dietitian for diet instruction and support at week 1,2,4,7,10,12 and thereafter at 24 weeks for a total of seven frontal meetings. Twice during the first 12 weeks the dietician will conduct 10-15-minute motivational telephone calls with all the participants.
| Study group | Role | What they receive |
|---|---|---|
| Low carbohydrate diet | Experimental | The LCD will provide 50-80g of carbohydrate per day with no caloric restriction. The planned macronutrient compositions (percentages of the total calories) of the diet were: 15-20% carbohydrate (<80 g/day), 33% protein and 58% total fat. Receives: Other: Low carbohydrate diet |
| Mediterranean diet | Active comparator | The MED group was prescribed a moderate-fat MED, rich in vegetables and low in red meat, with poultry and fish preferred to beef and lamb. The primary sources of added fat were 30 to 45 g of olive oil and a handful of nuts (five to seven nuts <20g) per day. The planned macronutrient compositions of the diet were 40-50% carbohydrate, 25% protein and 35% total fat. The diet is based on the recommendations of Willett and Skerrett Receives: Other: Low carbohydrate diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of time in range (TIR) 70-180 mg/dl after following a LCD or a MD in adolescents with T1DM.
Time spent in range (TIR) 70-180 mg/dl assessed by CGM was downloaded at each visit with the dietician. Severe hypoglycemia was defined as an episode requiring assistance and was confirmed by documentation of a blood glucose value less than 54 mg per deciliter
Measured: The change of TIR between baseline and after six months
Secondary outcomes (7)
Evaluation of the influence of LCD vs. MD on HbA1c.
Blood test for Hba1c will be taken at baseline and 24 weeks. Insulin dose and glycemic variability will be taken at each visit with the dietician from=n the pump and sensor downloads.
Measured: The change between baseline and after six months
Assessment of the impact of dietary changes after an LCD vs. MD on gut dysbiosis
Three stool samples will be take from each participant, and kept in -80c until being investigated in a lab
Measured: The change between baseline and after six months
Assessment of the impact of both diets on bone turnover measures.
Blood samples will be taken from the participants after a 12-hr fast at baseline,12 and 24 weeks. Bone markers: procollagen type 1 amino-terminal propeptide (P1NP) and bone resorption C-terminal telopeptide of type 1 collagen (CTx1) as well as cholesterol, LDL cholesterol, triglyceride and HDL cholesterol.
Measured: The change of bone turnover at baseline and after six months
Assessment of the impact of dietary changes after an LCD vs. MD on quality of life.
Quality of life questionnaire for type 1 diabetes adolescents will be given at baseline and after 6 months. A higher score reflects a better equality of life.
Measured: The change between baseline and after six months in the quality of life.
Change in BMI after LCD vs. MD
Measured height and weight will be taken at baseline and after 6 months of intervention in both arms and will be calculated into BMI. The outcome is the change in BMI at baseline and at the end of the intervention.
Measured: BMI change at baseline and after six months
Change in diet LCD vs. MED
FFQ (food frequency questionnaire) will be given at baseline and after 6 months to both arms, change of micronutrients and macronutrients will be calculated according to the questionnaire
Measured: Baseline and after six months
Change in LDL cholesterol
Blood test will be taken at baseline and after six months of intervention. Change in LDL cholesterol before and after the diets.
Measured: Baseline and after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start19 Apr 2023
- Primary completion31 Oct 2024 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study design is a randomized, parallel assignment clinical trial without blinding (open label) due to the impracticality of blinding diets
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Orit Hamiel, Sheba Medical Center
- Investigators
- Orit Pinhas-Hamiel, MD, Principal investigator, Head oh Pediatric Endocrinology Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872711
- Sponsor's protocol ID
- SHEBA-18-5537-OH-CTIL
- Status last verified
- May 2023
- First submitted
- 3 May 2023
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lennerz BS, Barton A, Bernstein RK, Dikeman RD, Diulus C, Hallberg S, Rhodes ET, Ebbeling CB, Westman EC, Yancy WS Jr, Ludwig DS. Management of Type 1 Diabetes With a Very Low-Carbohydrate Diet. Pediatrics. 2018 Jun;141(6):e20173349. doi: 10.1542/peds.2017-3349. Epub 2018 May 7.
PubMed 29735574Schmidt S, Christensen MB, Serifovski N, Damm-Frydenberg C, Jensen JB, Floyel T, Storling J, Ranjan A, Norgaard K. Low versus high carbohydrate diet in type 1 diabetes: A 12-week randomized open-label crossover study. Diabetes Obes Metab. 2019 Jul;21(7):1680-1688. doi: 10.1111/dom.13725. Epub 2019 Apr 21.
PubMed 30924570
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Carbohydrate Versus Mediterranean Diet in Adolescents With Type 1 Diabetes: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05872711
- Acronym / sponsor ID
- SHEBA-18-5537-OH-CTIL
- Conditions
- Type 1 Diabetes
- Keywords
- Adolescents, Glycemic targets, Low carbohydrate diet, Mediterranean diet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 19 Apr 2023 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 24 May 2023 (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.
The goal of this clinical trial is to compare the effect of low carbohydrate diet versus Mediterranean diet on blood sugar values in adolescents with type 1 diabetes.
The main question aims to answer whether a low carbohydrate diet is as effective as the Mediterranean diet for better glycaemic control in type 1 adolescents.
The investigators are also aiming to check whether low carbohydrate diet is safe and does not elevate cholesterol blood levels and whether the diet is adherable among youth with type 1 diabetes.
Participants with type 1 diabetes wearing a continuous glucose monitor and that will sign an informed consent will be randomly selected for 2 groups. One group will get the Mediterranean diet program and the other will get the low carbohydrate diet program, both for a duration of six months. Each participant will attend a cooking workshop at the beginning of the study. Blood work and stool samples will be taken at the beginning and 3 times through the study periodd. Each participant will attend meetings with the dietician thorough the period of the study.
Detailed description
Background and objective: Improved glycemic control of type 1 diabetes (T1DM), with low rates of adverse events was reported via an online community of children and adults who consume a of low carbohydrate diet (LCD). The investigators aim to compare the effects of a low carbohydrate diet (LCD) with those of a Mediterranean diet on glycemic control, lipid profile, bone metabolites and the microbiome profile in adolescents with type 1 diabetes.
Design A randomized, controlled trail. Families of adolescents in the Diabetes clinic in Edmond and Lily Safra Children's Hospital will be approached and offered to participate in a dietary intervention study. After participants will sign the informed consent, they will randomly be assigned into 2 diet treatment groups, the LCD (n=20) and the Mediterranean diet (n=20). Baseline nutrition teaching session and training and will be conducted for all participants and their parents. Participants will attend visit with the dietician at baseline, 2, 4, 8,12 weeks and will be given a 3-day food dairy to complete twice in that period. Measurements of weight, height, blood pressure, HbA1c, Time in range, number of hypoglycemia, lipid profile, creatinine, bone metabolites will be measured at baseline and 12 and 24 weeks and gut bacteria profile at baseline and at 24 weeks. Personality, quality of life, and socioeconomic questionnaires will be given to children and their parents.
Contribution of the suggested research:
In this research the investigators are aiming to show that LCD is as good as Mediterranean diet with improved glycemic control, safe, and adherable for adolescent with T1D.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study design is a randomized, parallel assignment clinical trial without blinding (open label) due to the impracticality of blinding diets
| Arm | Type | Receives |
|---|---|---|
| Low carbohydrate diet | Experimental | Other: Low carbohydrate dietThe LCD will provide 50-80g of carbohydrate per day with no caloric restriction. The planned macronutrient compositions (percentages of the total calories) of the diet were: 15-20% carbohydrate (<80 g/day), 33% protein and 58% total fat. |
| Mediterranean diet | Active comparator | Other: Low carbohydrate dietThe MED group was prescribed a moderate-fat MED, rich in vegetables and low in red meat, with poultry and fish preferred to beef and lamb. The primary sources of added fat were 30 to 45 g of olive oil and a handful of nuts (five to seven nuts <20g) per day. The planned macronutrient compositions of the diet were 40-50% carbohydrate, 25% protein and 35% total fat. The diet is based on the recommendations of Willett and Skerrett |
Who may qualify
- Ages
- 12 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Type 1 diabetes
- Connected to a continuous glucose monitoring (CGM)
Key exclusion criteria (2 listed)
- History of eating disorder
- Family history of mental disorders
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 |
|---|---|---|
| Low carbohydrate dietIn order to maintain equal intensity of treatment, each patient will get a cooking workshop and received a personalized diet regime at baseline, based on the randomly assigned diet. Format and quality of the materials are similar. All diet plans are individualized and matched for energy intake personally . Participants will meet individually with the dietitian for diet instruction and support at week 1,2,4,7,10,12 and thereafter at 24 weeks for a total of seven frontal meetings. Twice during the first 12 weeks the dietician will conduct 10-15-minute motivational telephone calls with all the participants. | Other | Low carbohydrate diet, Mediterranean diet |
Primary outcome
Change of time in range (TIR) 70-180 mg/dl after following a LCD or a MD in adolescents with T1DM.
Time frame: The change of TIR between baseline and after six months
Time spent in range (TIR) 70-180 mg/dl assessed by CGM was downloaded at each visit with the dietician. Severe hypoglycemia was defined as an episode requiring assistance and was confirmed by documentation of a blood glucose value less than 54 mg per deciliter
7 secondary outcomes
Evaluation of the influence of LCD vs. MD on HbA1c.
Time frame: The change between baseline and after six months
Assessment of the impact of dietary changes after an LCD vs. MD on gut dysbiosis
Time frame: The change between baseline and after six months
Assessment of the impact of both diets on bone turnover measures.
Time frame: The change of bone turnover at baseline and after six months
Assessment of the impact of dietary changes after an LCD vs. MD on quality of life.
Time frame: The change between baseline and after six months in the quality of life.
Change in BMI after LCD vs. MD
Time frame: BMI change at baseline and after six months
Change in diet LCD vs. MED
Time frame: Baseline and after six months
Change in LDL cholesterol
Time frame: Baseline and after 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Results publication: PubMed 29735574Lennerz BS, Barton A, Bernstein RK, Dikeman RD, Diulus C, Hallberg S, Rhodes ET, Ebbeling CB, Westman EC, Yancy WS Jr, Ludwig DS. Management of Type 1 Diabetes With a Very Low-Carbohydrate Diet. Pediatrics. 2018 Jun;141(6):e20173349. doi: 10.1542/peds.2017-3349. Epub 2018 May 7.
- Results publication: PubMed 30924570Schmidt S, Christensen MB, Serifovski N, Damm-Frydenberg C, Jensen JB, Floyel T, Storling J, Ranjan A, Norgaard K. Low versus high carbohydrate diet in type 1 diabetes: A 12-week randomized open-label crossover study. Diabetes Obes Metab. 2019 Jul;21(7):1680-1688. doi: 10.1111/dom.13725. Epub 2019 Apr 21.
- 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.
Orit Pinhas-Hamiel, MD principal investigator
Head oh Pediatric Endocrinology Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low carbohydrate diet in people with Type 1 Diabetes, run by Sheba Medical Center at 1 site in Israel.
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 2 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: status not confirmed, as of the sponsor's last update on 24 May 2023. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Orit Pinhas-Hamiel, MD (+97235305015, Orit.hamiel@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of time in range (TIR) 70-180 mg/dl after following a LCD or a MD in adolescents with T1DM. (time frame: The change of TIR between baseline and after six 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 NCT05872711, which also lists 2 linked publications.
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 24 May 2023.