Dietary HabitsNCT04550468

Low-carbohydrate Versus Low-fat Breakfast in Type 2 Diabetes

A study testing Low-Carb High-Fat breakfast in people with Dietary Habits, run by University of British Columbia at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 79 years
Conditions the study is for: Dietary Habits
What is being tested?: Low-Carb High-Fat breakfast
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 127 participants
Where: 1 siteCanada
Study dates: 1 Oct 2020to 30 Jun 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 79 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

physician-diagnosed T2D of ≥1 year;
current HbA1c of < 8.5%;
BMI: >25 kg/m2; (as of July 5, 2021, BMI cut off was expanded from 25-40 kg/m2 to higher than 25kg/m2 to facilitate recruitment)
blood pressure of <160/99 mm Hg assessed according to guidelines;
non-smoking;
not on hormone replacement therapy, corticosteroids, or anti-inflammatory medications;
20-79 years old.

Who cannot join

Use of exogenous insulin;
taking more than 2 glucose lowering medications;
ongoing medical treatment for diseases such as cancer, auto-immune or inflammatory disease, liver or kidney disorders;
allergy, intolerance or aversion to eggs or any other dietary restrictions (e.g., vegan, breakfast skipping) that will prevent them from following the standardized study diets;
being unable to follow remote guidance by internet or smartphone
being unable to follow the controlled diet instructions;.

Trial locations and contacts

1 site in 1 country.

Canada1 site

University of British Columbia
Kelowna, British Columbia, V1V 1V7

Other trials in Canada

About this study

Official title: Impact of a Low-carbohydrate Versus Low-fat Breakfast on Blood Glucose Control in Type 2 Diabetes

The prevalence of type 2 diabetes (T2D) is increasing worldwide, with ~380 M currently suffering from this chronic, debilitating disease. T2D is characterized by high blood glucose levels in the mornings and after meals. The largest hyperglycemic spike often occurs after breakfast. Targeting this meal may be a simple, feasible strategy to improve glycemic control and reduce risk for diabetes complications. It is hypothesized that consuming a low carbohydrate high fat (LCHF) breakfast for 3 months, when compared to a standard low-fat breakfast will improve blood glucose control, increase satiety and improve body composition in people with T2D. This information will test whether the simple dietary strategy of limiting carbohydrates at breakfast could help in managing T2D.

Read the detailed description

A 3-month parallel-group randomized controlled trial will be conducted. Eligible participants will be randomized to either the Low-carb High-fat breakfast (LCHF, n=41) or a low-fat "standard care" control breakfast (CTL, n=41), to be consumed daily for a period of 3 months.

Due to COVID-19 pandemic, this study was adapted to be conducted remotely through video/telephone conference meetings between participants and study staff, along with mailing of study materials before and after the intervention for remote data collection.

Each group will be provided with a menu of 8 LCHF breakfasts or 8 CTL breakfasts from which to choose each morning. Breakfast options (designed by a registered dietitian) will be controlled in macronutrient content and calories (~400-500 kcal), but allow for personal preference and autonomy to promote adherence.

Conditions: Dietary Habits
Being tested: Low-Carb High-Fat breakfast, Low fat "standard care" control breakfast
Medical subject headings: Feeding Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Low-Carb High-Fat breakfastOther
Participants will receive 8 low-carb high-fat breakfast meal recipes to follow daily during 3 months.
Low fat "standard care" control breakfastOther
Participants will receive 8 low-fat breakfast meal recipes to follow daily during 3 months.

Study groups in NCT04550468
Study group	Role	What they receive
Low-Carb High-Fat Breakfast	Experimental	Participants will follow a daily low carbohydrate high fat breakfast intervention for 3 months. Receives: Other: Low-Carb High-Fat breakfast
Low fat "Standard Care" Control Breakfast	Active comparator	Participants will follow a daily low fat "standard care" control breakfast intervention for 3 months. Receives: Other: Low fat "standard care" control breakfast

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline Hemoglobin A1c at 12 Weeks
Hemoglobin A1c measured at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast
Measured: Baseline to 12 weeks of diet

Secondary outcomes (9)

Change From Baseline Fasting Blood Glucose at 12 Weeks
Mean fasting blood glucose from 14 days measured at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast
Measured: Mean values for the first 14 days (weeks 1-2) and mean values for the last 14 days (weeks 11-12) of the intervention
Change From Baseline Fasting Blood Insulin at 12 Weeks
Average fasting blood insulin measured at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast
Measured: Baseline to 12 weeks of diet
Change From Baseline Blood Lipids at 12 Weeks
Mean triglycerides, total, HDL, and LDL cholesterol at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfas
Measured: Baseline to 12 weeks of diet
Change From Baseline Inflammation Marker High Sensitive Reactive Protein (hsCRP) at 12 Weeks
Blood inflammation marker (hsCRP) at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast
Measured: Baseline to 12 weeks of diet
Hunger/Satiety Levels
Levels of hunger and satiety measured by a 0 to 100 millimeter visual analog scale [ranges across a continuum from none (0) to an extreme amount (100) of Hunger, Satiety, Fullness, Appetite] How hungry do you feel? How satisfied do you feel? How full do you feel? How much food do you think you can eat?
Measured: Weeks 1, 6 and 12
Dietary Intake
Dietary calorie intake assessed by three 3-day food records during the 12-week intervention
Measured: Mean dietary intake assessed during the 12-week intervention
Change From Baseline Body Weight at 12 Weeks
Body weight measured in kilograms at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast
Measured: Baseline to 12 weeks of diet
Change From Baseline Body Mass Index at 12 Weeks
Body mass Index measured in weight in kilograms divided by the square of height in meters at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast
Measured: Baseline to 12 weeks of diet
Continuous Glucose Monitoring
Measures of overall glucose control by continuous glucose monitoring device
Measured: Mean values for the first 14 days (weeks 1-2) and mean values for the last 14 days (weeks 11-12) of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 202030 Jun 2022

First posted16 Sep 2020
Study start1 Oct 2020
Primary completion30 Jun 2022
Study completion30 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Dietary HabitsStudies of the same condition, open and under way.
More trials run by University of British ColumbiaThe 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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 127 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04550468
Sponsor's protocol ID: H19-03179
Status last verified: Feb 2025
First submitted: 15 Jul 2020
Last updated: 4 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Oliveira BF, Chang CR, Oetsch K, Falkenhain K, Crampton K, Stork M, Hoonjan M, Elliott T, Francois ME, Little JP. Impact of a Low-Carbohydrate Compared with Low-Fat Breakfast on Blood Glucose Control in Type 2 Diabetes: A Randomized Trial. Am J Clin Nutr. 2023 Jul;118(1):209-217. doi: 10.1016/j.ajcnut.2023.04.032. Epub 2023 May 29.
PubMed 37257563

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of a Low-carbohydrate Versus Low-fat Breakfast on Blood Glucose Control in Type 2 Diabetes
ClinicalTrials.gov ID: NCT04550468
Acronym / sponsor ID: H19-03179
Conditions: Dietary Habits
Study type: Interventional
Recruitment status: Completed
Enrolment: 127 participants (actual)
Lead sponsor: University of British ColumbiaUniversity, hospital or other
Collaborators: University of Wollongong
Study start: 1 Oct 2020 (actual)
Primary completion: 30 Jun 2022 (actual)
Study completion: 30 Jun 2022 (actual)
First posted: 16 Sep 2020 (actual)
Results: Posted 4 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Low-Carb High-Fat Breakfast	Experimental	Other: Low-Carb High-Fat breakfastParticipants will follow a daily low carbohydrate high fat breakfast intervention for 3 months.
Low fat "Standard Care" Control Breakfast	Active comparator	Other: Low fat "standard care" control breakfastParticipants will follow a daily low fat "standard care" control breakfast intervention for 3 months.

Who may qualify

Ages: 20 to 79 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

physician-diagnosed T2D of ≥1 year;
current HbA1c of < 8.5%;
BMI: >25 kg/m2; (as of July 5, 2021, BMI cut off was expanded from 25-40 kg/m2 to higher than 25kg/m2 to facilitate recruitment)
blood pressure of <160/99 mm Hg assessed according to guidelines;
non-smoking;

Key exclusion criteria (6 listed)

Use of exogenous insulin;
taking more than 2 glucose lowering medications;
ongoing medical treatment for diseases such as cancer, auto-immune or inflammatory disease, liver or kidney disorders;
allergy, intolerance or aversion to eggs or any other dietary restrictions (e.g., vegan, breakfast skipping) that will prevent them from following the standardized study diets;
being unable to follow remote guidance by internet or smartphone

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-Carb High-Fat breakfastParticipants will receive 8 low-carb high-fat breakfast meal recipes to follow daily during 3 months.	Other	Low-Carb High-Fat Breakfast
Low fat "standard care" control breakfastParticipants will receive 8 low-fat breakfast meal recipes to follow daily during 3 months.	Other	Low fat "Standard Care" Control Breakfast

Primary outcome

Change From Baseline Hemoglobin A1c at 12 Weeks
Time frame: Baseline to 12 weeks of diet
Hemoglobin A1c measured at baseline and after 12 weeks of following the low-carbohydrate breakfast or low-fat breakfast

9 secondary outcomes

Change From Baseline Fasting Blood Glucose at 12 Weeks
Time frame: Mean values for the first 14 days (weeks 1-2) and mean values for the last 14 days (weeks 11-12) of the intervention
Change From Baseline Fasting Blood Insulin at 12 Weeks
Time frame: Baseline to 12 weeks of diet
Change From Baseline Blood Lipids at 12 Weeks
Time frame: Baseline to 12 weeks of diet
Change From Baseline Inflammation Marker High Sensitive Reactive Protein (hsCRP) at 12 Weeks
Time frame: Baseline to 12 weeks of diet
Hunger/Satiety Levels
Time frame: Weeks 1, 6 and 12
Dietary Intake
Time frame: Mean dietary intake assessed during the 12-week intervention
Change From Baseline Body Weight at 12 Weeks
Time frame: Baseline to 12 weeks of diet
Change From Baseline Body Mass Index at 12 Weeks
Time frame: Baseline to 12 weeks of diet
Continuous Glucose Monitoring
Time frame: Mean values for the first 14 days (weeks 1-2) and mean values for the last 14 days (weeks 11-12) of treatment

Results and safety

Results posted to the registry on 4 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Low-Carb High-Fat Breakfast	64	45
Low Fat "Standard Care" Control Breakfast	63	48

Primary outcome: Change From Baseline Hemoglobin A1c at 12 Weeks

Time frame: Baseline to 12 weeks of diet. Mean (95% Confidence Interval). Unit: % of HbA1c

Measure	Low-Carb High-Fat Breakfast n = 60	Low Fat "Standard Care" Control Breakfast n = 61
Value	-0.3 (-0.4 to -0.1)	-0.1 (-0.2 to 0.1)

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Low-Carb High-Fat Breakfast	0 of 64 (0%)	0 of 64 (0%)	0 of 64
Low Fat "Standard Care" Control Breakfast	0 of 63 (0%)	0 of 63 (0%)	0 of 63

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37257563Oliveira BF, Chang CR, Oetsch K, Falkenhain K, Crampton K, Stork M, Hoonjan M, Elliott T, Francois ME, Little JP. Impact of a Low-Carbohydrate Compared with Low-Fat Breakfast on Blood Glucose Control in Type 2 Diabetes: A Randomized Trial. Am J Clin Nutr. 2023 Jul;118(1):209-217. doi: 10.1016/j.ajcnut.2023.04.032. Epub 2023 May 29.

Related trials for Dietary Habits

Recruiting
Nutrition Outcomes Using a Randomized Intervention Via Smartphone on Dietary Habits
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Recruiting
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Not yet recruiting
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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 Low-Carb High-Fat breakfast in people with Dietary Habits, run by University of British Columbia 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 7 inclusion and 6 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 Feb 2025. 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. 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?

Yes. Results are posted in the registry (first posted 4 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline Hemoglobin A1c at 12 Weeks (time frame: Baseline to 12 weeks of diet). 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 NCT04550468, 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 Feb 2025.