Ketogenic DietingNCT04195594
An Study Investigating Nic's Keto Diet on Cardiovascular Health in Healthy Adults With Mildly Elevated LDL Levels
A study testing Nic's Keto Diet in people with Ketogenic Dieting and Healthy, run by TRC GEN+ managed by Trans Russian co Cy at 1 site in Canada.
Trial summary
The present study will investigate the effects of Nic's Ketogenic diet, comprised of 70% fat, 5% carbohydrate, and 25% protein on middle-aged males and females with mid-range elevated LDL. Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Ketogenic Dieting, Healthy
- What is being tested?
- Nic's Keto Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- 14 Jan 2020to 13 Oct 2020
- 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 30 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provided voluntary, written, informed consent to participate in study
- Males and females between 30 and 55 years of age
- BMI between 20.0 to 29.9 kg/m2, inclusive
- Female participant is not of child-bearing potential, defined as females who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, total endometrial ablation) Or,
- Females of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. Acceptable methods of birth control include:
- Non hormonal contraceptives
Show all 14Show fewer
- Double-barrier method
- Intrauterine devices
- Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
- Vasectomy of partner at least 6 months prior to screening
- Subjects with mid-range (2.5-4.1mmol/L or 100-159 mg/dL) elevated LDL-C levels
- Agrees to maintain current level of physical activity throughout the study
- Willingness to complete all questionnaires, records, and diaries and assessments associated with the study and to complete all clinic visits.
- Healthy as determined by medical history, laboratory results, and as assessed by Qualified Investigator (QI)
Who cannot join
- Women who are pregnant, breast feeding, or planning to become pregnant during the course of the trial
- Women who are menopausal or post-menopausal
- Currently following a diet (i.e. Ketogenic Diet, low-carbohydrate diet)
- Subjects with high TSH level (>4.5mU/L) or Self reported pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
- Participants with type I or II Diabetes Mellitus
- Cancer, except skin cancers completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable.
Show all 27Show fewer
- Participants with previous or current pathology of the pancreas
- Current or history of Gastroesophageal reflux disease (GERD) or any significant disease of the gastrointestinal tract
- Self reported hypertension or on hypertensives.
- Significant cardiovascular event in the past 6 months as assessed by the QI.
- Major surgery in the past 3 months or individuals who have planned surgery during the course of the trial. Participants with minor surgery will be considered on a case-by-case basis by the QI
- Gastric bypass surgery
- Individuals with an autoimmune disease or are immune-compromised
- Self reported HIV-, Hepatitis B- and/or C-positive diagnosis
- History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones symptom free for 6 months
- Self reported medical or neuropsychological condition and/or cognitive impairment that, in the QI's opinion, could interfere with study participation
- Self reported blood/bleeding disorders as per QI
- Current use of prescribed medications listed in Section 7.3.1
- Current use of over-the-counter medications, supplements, foods, and/or drinks listed in Section 7.3.2
- Alcohol or drug abuse within the last 12 months
- High alcohol intake (>2 standard drinks per day or >10 standard drinks per week)
- Clinically significant abnormal laboratory results at screening as assessed by the QI
- Metal implants that may affect the DEXA scan results will be assessed on case-by-case basis by the QI
- Blood donation 30 days prior to screening, during the study, or a planned donation within 30-days of the last study visit
- Participation in a clinical research trial within 30 days of study initiation
- Individuals who are unable to give informed consent
- Any other active or unstable medical condition, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or may pose significant risk to the participant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Study to Investigate the Efficacy of Nic's Keto Diet on Cardiovascular Health in Healthy Adults With Mildly Elevated LDL Levels
The present study will investigate the effects of Nic's Ketogenic diet, comprised of 70% fat, 5% carbohydrate, and 25% protein on middle-aged males and females with mid-range elevated LDL. With the mixed evidence on the causative effect of LDL cholesterol on increased cardiovascular health risk, further studies are warranted to examine the relation of elevated LDL and other biomarkers of cardiovascular health in response to a lifestyle intervention. Furthermore, this study will investigate weight loss and body composition changes with adherence to this dietary intervention over a 140-day period. In this study the efficacy of Nic's Ketogenic diet on weight loss and biomarkers of cardiovascular health will be examined.
- Conditions
- Ketogenic Dieting, Healthy
- Being tested
- Nic's Keto Diet
- Keywords
- Ketogenic Diet, Nic's keto diet, Cardiovascular health, Elevated LDL levels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nic's Keto DietOther
Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
| Study group | Role | What they receive |
|---|---|---|
| Nic's Keto Diet | Experimental | Not described Receives: Other: Nic's Keto Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes to Body Fat Percentage as Assessed by DEXA Scan From Baseline to Day 70 Following Nic's Keto Diet
The DEXA scan is a form of X-ray radiation that measures the body tissue density, which was reported at baseline and compared to day 70.
Measured: 70 days
Changes to Muscle Mass Percentage as Assessed by DEXA Scan From Baseline to Day 70 Following Nic's Keto Diet
The DEXA scan is a form of X-ray radiation that measures the body tissue density, which was reported at baseline and compared to day 70.
Measured: 70 days
Changes to Body Fat Percentage as Assessed by DEXA Scan From Baseline to Day 140 Following Nic's Keto Diet
The DEXA scan is a form of X-ray radiation that measures the body tissue density, which was reported at baseline and compared to day 140.
Measured: 140 days
Changes to Muscle Mass Percentage as Assessed by DEXA Scan From Baseline to Day 140 Following Nic's Keto Diet
The DEXA scan is a form of X-ray radiation that measures the body tissue density, which was reported at baseline and compared to day 140.
Measured: 140 days
Changes to Weight as Assessed by BMI From Baseline to Day 70 Following Nic's Keto Diet
Changes to weight as assessed by BMI was reported at baseline and compared to day 70.
Measured: 70 days
Changes to Weight as Assessed by BMI From Baseline to Day 140 Following Nic's Keto Diet
Changes to weight as assessed by BMI was reported at baseline and compared to day 140.
Measured: 140 days
Secondary outcomes (43)
The Change in Inflammation, as Assessed by the Change in Erythrocyte Sedimentation Rate (ESR) Following Nic's Keto Diet for 140 Days
The change in inflammation, as assessed by the change in erythrocyte sedimentation rate (ESR) following Nic's Keto Diet was reported at 140 days.
Measured: 140 days
The Change in Inflammation, as Assessed by the Change in C-reactive Protein (CRP) Following Nic's Keto Diet for 140 Days
The change in inflammation, as assessed by the change in C-reactive protein (CRP) following Nic's Keto Diet was reported at 140 days.
Measured: 140 days
Changes to Weight From Baseline to Day 28 Following Nic's Keto Diet
Changes to weight from baseline were reported and compared to day 28 following Nic's Keto Diet.
Measured: 28 days
Changes to Weight From Baseline to Day 56 Following Nic's Keto Diet
Changes to weight from baseline were reported and compared to day 56 following Nic's Keto Diet.
Measured: 56 days
Changes to Weight From Baseline to Day 84 Following Nic's Keto Diet
Changes to weight from baseline were reported and compared to day 84 following Nic's Keto Diet.
Measured: 84 days
Changes to Weight From Baseline to Day 112 Following Nic's Keto Diet
Changes to weight from baseline were reported and compared to day 112 following Nic's Keto Diet.
Measured: 112 days
Changes to Systolic Blood Pressure From Baseline to Day 28 Following Nic's Keto Diet
Changes to systolic blood pressure from baseline were reported and compared to day 28 following Nic's Keto Diet.
Measured: 28 days
Changes to Systolic Blood Pressure From Baseline to Day 56 Following Nic's Keto Diet
Changes to systolic blood pressure from baseline were reported and compared to day 56 following Nic's Keto Diet.
Measured: 56 days
Changes to Systolic Blood Pressure From Baseline to Day 84 Following Nic's Keto Diet
Changes to systolic blood pressure from baseline were reported and compared to day 84 following Nic's Keto Diet.
Measured: 84 days
Changes to Systolic Blood Pressure From Baseline to Day 112 Following Nic's Keto Diet
Changes to systolic blood pressure from baseline were reported and compared to day 112 following Nic's Keto Diet.
Measured: 112 days
Changes to Systolic Blood Pressure From Baseline to Day 140 Following Nic's Keto Diet
Changes to systolic blood pressure from baseline were reported and compared to day 140 following Nic's Keto Diet.
Measured: 140 days
Changes to Total Cholesterol From Baseline to Day 28 Following Nic's Keto Diet
Changes to total cholesterol were reported from baseline and compared to day 28 following Nic's Keto diet using blood analysis (units in mmol/L)
Measured: 28 days
Changes to Triglyceride Level From Baseline to Day 28 Following Nic's Keto Diet
Changes to triglyceride level were reported from baseline and compared to day 28 following Nic's Keto diet using blood analysis (units in mmol/L).
Measured: 28 days
Changes to HDL-Cholesterol From Baseline to Day 28 Following Nic's Keto Diet
Changes to HDL-cholesterol from baseline to day 28 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Measured: 28 days
Changes to LDL-Cholesterol From Baseline to Day 28 Following Nic's Keto Diet
Changes to LDL-cholesterol from baseline to day 28 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Measured: 28 days
Changes to Total Cholesterol From Baseline to Day 56 Following Nic's Keto Diet
Changes to total cholesterol from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Measured: 56 days
Changes to Triglyceride Level From Baseline to Day 56 Following Nic's Keto Diet
Changes to triglyceride level from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Measured: 56 days
Changes to HDL-Cholesterol From Baseline to Day 56 Following Nic's Keto Diet
Changes to HDL-Cholesterol from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Measured: 56 days
Changes to LDL-Cholesterol From Baseline to Day 56 Following Nic's Keto Diet
Changes to LDL-Cholesterol from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Measured: 56 days
Changes to Total Cholesterol From Baseline to Day 84 Following Nic's Keto Diet
Changes to total cholesterol from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Measured: 84 days
Changes to Triglyceride Level From Baseline to Day 84 Following Nic's Keto Diet
Changes to triglyceride level from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Measured: 84 days
Changes to HDL-Cholesterol From Baseline to Day 84 Following Nic's Keto Diet
Changes to HDL-Cholesterol from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Measured: 84 days
Changes to LDL-Cholesterol From Baseline to Day 84 Following Nic's Keto Diet
Changes to LDL-Cholesterol from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Measured: 84 days
Changes to Total Cholesterol From Baseline to Day 112 Following Nic's Keto Diet
Changes to total cholesterol from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Measured: 112 days
Changes to Triglyceride Level From Baseline to Day 112 Following Nic's Keto Diet
Changes to triglyceride level from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Measured: 112 days
Changes to HDL-Cholesterol From Baseline to Day 112 Following Nic's Keto Diet
Changes to HDL-Cholesterol from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Measured: 112 days
Changes to LDL-Cholesterol From Baseline to Day 112 Following Nic's Keto Diet
Changes to LDL-Cholesterol from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Measured: 112 days
Changes to Total Cholesterol From Baseline to Day 140 Following Nic's Keto Diet
Changes to total cholesterol from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Measured: 140 days
Changes to Triglyceride Level From Baseline to Day 140 Following Nic's Keto Diet
Changes to triglyceride level from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Measured: 140 days
Changes to HDL-Cholesterol From Baseline to Day 140 Following Nic's Keto Diet
Changes to HDL-Cholesterol from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Measured: 140 days
Changes to LDL-Cholesterol From Baseline to Day 140 Following Nic's Keto Diet
Changes to LDL-Cholesterol from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L).
Measured: 140 days
Changes to HbA1c From Baseline to Day 140 Following Nic's Keto Diet
Changes to HbA1c were reported at baseline and compared to day 140 following Nic's Keto Diet.
Measured: 140 days
Changes to Fasting Glucose From Baseline to Day 140 Following Nic's Keto Diet
Changes to fasting glucose were reported at baseline and compared to day 140 following Nic's Keto Diet.
Measured: 140 days
Changes to Free Tri-iodothyronine (T3) From Baseline to Day 140 Following Nic's Keto Diet
Changes to free tri-iodothyronine (T3) were reported at baseline and compared to day 140 following Nic's Keto Diet.
Measured: 140 days
Changes to Weight From Baseline to Day 70 Following Nic's Keto Diet
Changes to weight were reported from baseline and compared to day 70 following Nic's Keto Diet.
Measured: 70 days
Changes to Weight From Baseline to Day 140 Following Nic's Keto Diet
Changes to weight were reported from baseline and compared to Day 140 following Nic's Keto Diet.
Measured: 140 days
Changes to Systolic Blood Pressure From Baseline to Day 70 Following Nic's Keto Diet
Changes to systolic blood pressure were reported from baseline and compared to Day 70 following Nic's Keto Diet.
Measured: 70 days
Changes to Diastolic Blood Pressure From Baseline to Day 28 Following Nic's Keto Diet
Changes to diastolic blood pressure were reported from baseline and compared to Day 28 following Nic's Keto Diet.
Measured: 28 days
Changes to Diastolic Blood Pressure From Baseline to Day 56 Following Nic's Keto Diet
Changes to diastolic blood pressure were reported from baseline and compared to Day 56 following Nic's Keto Diet.
Measured: 56 days
Changes to Diastolic Blood Pressure From Baseline to Day 70 Following Nic's Keto Diet
Changes to diastolic blood pressure were reported from baseline and compared to Day 70 following Nic's Keto Diet.
Measured: 70 days
Changes to Diastolic Blood Pressure From Baseline to Day 84 Following Nic's Keto Diet
Changes to diastolic blood pressure were reported from baseline and compared to Day 84 following Nic's Keto Diet.
Measured: 84 days
Changes to Diastolic Blood Pressure From Baseline to Day 112 Following Nic's Keto Diet
Changes to diastolic blood pressure were reported from baseline and compared to Day 112 following Nic's Keto Diet.
Measured: 112 days
Changes to Diastolic Blood Pressure From Baseline to Day 140 Following Nic's Keto Diet
Changes to diastolic blood pressure were reported from baseline and compared to Day 140 following Nic's Keto Diet.
Measured: 140 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start14 Jan 2020
- Primary completion13 Oct 2020
- Study completion13 Oct 2020
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 Ketogenic DietingStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-Label
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- TRC GEN+ managed by Trans Russian co Cy
- Sponsor type
- University, hospital or other
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- David Crowley, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04195594
- Sponsor's protocol ID
- 19KLHT
- Status last verified
- Apr 2021
- First submitted
- 4 Dec 2019
- Last updated
- 4 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tzenios N, Lewis ED, Crowley DC, Chahine M, Evans M. Examining the Efficacy of a Very-Low-Carbohydrate Ketogenic Diet on Cardiovascular Health in Adults with Mildly Elevated Low-Density Lipoprotein Cholesterol in an Open-Label Pilot Study. Metab Syndr Relat Disord. 2022 Mar;20(2):94-103. doi: 10.1089/met.2021.0042. Epub 2021 Dec 16.
PubMed 34918971
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study to Investigate the Efficacy of Nic's Keto Diet on Cardiovascular Health in Healthy Adults With Mildly Elevated LDL Levels
- ClinicalTrials.gov ID
- NCT04195594
- Acronym / sponsor ID
- 19KLHT
- Conditions
- Ketogenic Dieting, Healthy
- Keywords
- Ketogenic Diet, Nic's keto diet, Cardiovascular health, Elevated LDL levels
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- TRC GEN+ managed by Trans Russian co CyUniversity, hospital or other
- Collaborators
- KGK Science Inc.
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 13 Oct 2020 (actual)
- Study completion
- 13 Oct 2020 (actual)
- First posted
- 12 Dec 2019 (actual)
- Results
- Posted 4 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study will investigate the effects of Nic's Ketogenic diet, comprised of 70% fat, 5% carbohydrate, and 25% protein on middle-aged males and females with mid-range elevated LDL. With the mixed evidence on the causative effect of LDL cholesterol on increased cardiovascular health risk, further studies are warranted to examine the relation of elevated LDL and other biomarkers of cardiovascular health in response to a lifestyle intervention. Furthermore, this study will investigate weight loss and body composition changes with adherence to this dietary intervention over a 140-day period. In this study the efficacy of Nic's Ketogenic diet on weight loss and biomarkers of cardiovascular health will be examined.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-Label
| Arm | Type | Receives |
|---|---|---|
| Nic's Keto Diet | Experimental | Other: Nic's Keto Diet |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Provided voluntary, written, informed consent to participate in study
- Males and females between 30 and 55 years of age
- BMI between 20.0 to 29.9 kg/m2, inclusive
- Female participant is not of child-bearing potential, defined as females who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, total endometrial ablation) Or,
- Females of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. Acceptable methods of birth control include:
Key exclusion criteria (27 listed)
- Women who are pregnant, breast feeding, or planning to become pregnant during the course of the trial
- Women who are menopausal or post-menopausal
- Currently following a diet (i.e. Ketogenic Diet, low-carbohydrate diet)
- Subjects with high TSH level (>4.5mU/L) or Self reported pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
- Participants with type I or II Diabetes Mellitus
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 |
|---|---|---|
| Nic's Keto DietParticipants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources. | Other | Nic's Keto Diet |
Primary outcome
Changes to Body Fat Percentage as Assessed by DEXA Scan From Baseline to Day 70 Following Nic's Keto Diet
Time frame: 70 days
The DEXA scan is a form of X-ray radiation that measures the body tissue density, which was reported at baseline and compared to day 70.
Changes to Muscle Mass Percentage as Assessed by DEXA Scan From Baseline to Day 70 Following Nic's Keto Diet
Time frame: 70 days
The DEXA scan is a form of X-ray radiation that measures the body tissue density, which was reported at baseline and compared to day 70.
Changes to Body Fat Percentage as Assessed by DEXA Scan From Baseline to Day 140 Following Nic's Keto Diet
Time frame: 140 days
The DEXA scan is a form of X-ray radiation that measures the body tissue density, which was reported at baseline and compared to day 140.
Changes to Muscle Mass Percentage as Assessed by DEXA Scan From Baseline to Day 140 Following Nic's Keto Diet
Time frame: 140 days
The DEXA scan is a form of X-ray radiation that measures the body tissue density, which was reported at baseline and compared to day 140.
Changes to Weight as Assessed by BMI From Baseline to Day 70 Following Nic's Keto Diet
Time frame: 70 days
Changes to weight as assessed by BMI was reported at baseline and compared to day 70.
Changes to Weight as Assessed by BMI From Baseline to Day 140 Following Nic's Keto Diet
Time frame: 140 days
Changes to weight as assessed by BMI was reported at baseline and compared to day 140.
43 secondary outcomes
The Change in Inflammation, as Assessed by the Change in Erythrocyte Sedimentation Rate (ESR) Following Nic's Keto Diet for 140 Days
Time frame: 140 days
The Change in Inflammation, as Assessed by the Change in C-reactive Protein (CRP) Following Nic's Keto Diet for 140 Days
Time frame: 140 days
Changes to Weight From Baseline to Day 28 Following Nic's Keto Diet
Time frame: 28 days
Changes to Weight From Baseline to Day 56 Following Nic's Keto Diet
Time frame: 56 days
Changes to Weight From Baseline to Day 84 Following Nic's Keto Diet
Time frame: 84 days
Changes to Weight From Baseline to Day 112 Following Nic's Keto Diet
Time frame: 112 days
Changes to Systolic Blood Pressure From Baseline to Day 28 Following Nic's Keto Diet
Time frame: 28 days
Changes to Systolic Blood Pressure From Baseline to Day 56 Following Nic's Keto Diet
Time frame: 56 days
Changes to Systolic Blood Pressure From Baseline to Day 84 Following Nic's Keto Diet
Time frame: 84 days
Changes to Systolic Blood Pressure From Baseline to Day 112 Following Nic's Keto Diet
Time frame: 112 days
Changes to Systolic Blood Pressure From Baseline to Day 140 Following Nic's Keto Diet
Time frame: 140 days
Changes to Total Cholesterol From Baseline to Day 28 Following Nic's Keto Diet
Time frame: 28 days
Changes to Triglyceride Level From Baseline to Day 28 Following Nic's Keto Diet
Time frame: 28 days
Changes to HDL-Cholesterol From Baseline to Day 28 Following Nic's Keto Diet
Time frame: 28 days
Changes to LDL-Cholesterol From Baseline to Day 28 Following Nic's Keto Diet
Time frame: 28 days
Changes to Total Cholesterol From Baseline to Day 56 Following Nic's Keto Diet
Time frame: 56 days
Changes to Triglyceride Level From Baseline to Day 56 Following Nic's Keto Diet
Time frame: 56 days
Changes to HDL-Cholesterol From Baseline to Day 56 Following Nic's Keto Diet
Time frame: 56 days
Changes to LDL-Cholesterol From Baseline to Day 56 Following Nic's Keto Diet
Time frame: 56 days
Changes to Total Cholesterol From Baseline to Day 84 Following Nic's Keto Diet
Time frame: 84 days
Changes to Triglyceride Level From Baseline to Day 84 Following Nic's Keto Diet
Time frame: 84 days
Changes to HDL-Cholesterol From Baseline to Day 84 Following Nic's Keto Diet
Time frame: 84 days
Changes to LDL-Cholesterol From Baseline to Day 84 Following Nic's Keto Diet
Time frame: 84 days
Changes to Total Cholesterol From Baseline to Day 112 Following Nic's Keto Diet
Time frame: 112 days
Changes to Triglyceride Level From Baseline to Day 112 Following Nic's Keto Diet
Time frame: 112 days
Changes to HDL-Cholesterol From Baseline to Day 112 Following Nic's Keto Diet
Time frame: 112 days
Changes to LDL-Cholesterol From Baseline to Day 112 Following Nic's Keto Diet
Time frame: 112 days
Changes to Total Cholesterol From Baseline to Day 140 Following Nic's Keto Diet
Time frame: 140 days
Changes to Triglyceride Level From Baseline to Day 140 Following Nic's Keto Diet
Time frame: 140 days
Changes to HDL-Cholesterol From Baseline to Day 140 Following Nic's Keto Diet
Time frame: 140 days
Changes to LDL-Cholesterol From Baseline to Day 140 Following Nic's Keto Diet
Time frame: 140 days
Changes to HbA1c From Baseline to Day 140 Following Nic's Keto Diet
Time frame: 140 days
Changes to Fasting Glucose From Baseline to Day 140 Following Nic's Keto Diet
Time frame: 140 days
Changes to Free Tri-iodothyronine (T3) From Baseline to Day 140 Following Nic's Keto Diet
Time frame: 140 days
Changes to Weight From Baseline to Day 70 Following Nic's Keto Diet
Time frame: 70 days
Changes to Weight From Baseline to Day 140 Following Nic's Keto Diet
Time frame: 140 days
Changes to Systolic Blood Pressure From Baseline to Day 70 Following Nic's Keto Diet
Time frame: 70 days
Changes to Diastolic Blood Pressure From Baseline to Day 28 Following Nic's Keto Diet
Time frame: 28 days
Changes to Diastolic Blood Pressure From Baseline to Day 56 Following Nic's Keto Diet
Time frame: 56 days
Changes to Diastolic Blood Pressure From Baseline to Day 70 Following Nic's Keto Diet
Time frame: 70 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34918971Tzenios N, Lewis ED, Crowley DC, Chahine M, Evans M. Examining the Efficacy of a Very-Low-Carbohydrate Ketogenic Diet on Cardiovascular Health in Adults with Mildly Elevated Low-Density Lipoprotein Cholesterol in an Open-Label Pilot Study. Metab Syndr Relat Disord. 2022 Mar;20(2):94-103. doi: 10.1089/met.2021.0042. Epub 2021 Dec 16.
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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.
David Crowley, MD principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nic's Keto Diet in people with Ketogenic Dieting and Healthy, run by TRC GEN+ managed by Trans Russian co Cy 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 14 inclusion and 27 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 May 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 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 May 2021). 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?
Changes to Body Fat Percentage as Assessed by DEXA Scan From Baseline to Day 70 Following Nic's Keto Diet (time frame: 70 days). The study lists 6 primary outcomes in all. 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 NCT04195594, 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 May 2021.