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Completed

NCT Number: NCT04195594

An Study Investigating 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.

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Key information

Conditions

Ketogenic Dieting Healthy

Age range

30 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KGK Science Inc.

London, Ontario, N6A 5R8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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)

Exclusion criteria

  • 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.
  • 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

Treatment and study plan

Nic's Keto Diet

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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 erythrocyte sedimentation rate (ESR) following Nic's Keto Diet was reported at 140 days.

  2. 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

    The change in inflammation, as assessed by the change in C-reactive protein (CRP) following Nic's Keto Diet was reported at 140 days.

  3. Changes to Weight From Baseline to Day 28 Following Nic's Keto Diet

    Time frame: 28 days

    Changes to weight from baseline were reported and compared to day 28 following Nic's Keto Diet.

  4. Changes to Weight From Baseline to Day 56 Following Nic's Keto Diet

    Time frame: 56 days

    Changes to weight from baseline were reported and compared to day 56 following Nic's Keto Diet.

  5. Changes to Weight From Baseline to Day 84 Following Nic's Keto Diet

    Time frame: 84 days

    Changes to weight from baseline were reported and compared to day 84 following Nic's Keto Diet.

  6. Changes to Weight From Baseline to Day 112 Following Nic's Keto Diet

    Time frame: 112 days

    Changes to weight from baseline were reported and compared to day 112 following Nic's Keto Diet.

  7. 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 were reported and compared to day 28 following Nic's Keto Diet.

  8. 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 were reported and compared to day 56 following Nic's Keto Diet.

  9. 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 were reported and compared to day 84 following Nic's Keto Diet.

  10. 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 were reported and compared to day 112 following Nic's Keto Diet.

  11. Changes to Systolic Blood Pressure From Baseline to Day 140 Following Nic's Keto Diet

    Time frame: 140 days

    Changes to systolic blood pressure from baseline were reported and compared to day 140 following Nic's Keto Diet.

  12. Changes to Total Cholesterol From Baseline to Day 28 Following Nic's Keto Diet

    Time frame: 28 days

    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)

  13. Changes to Triglyceride Level From Baseline to Day 28 Following Nic's Keto Diet

    Time frame: 28 days

    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).

  14. Changes to HDL-Cholesterol From Baseline to Day 28 Following Nic's Keto Diet

    Time frame: 28 days

    Changes to HDL-cholesterol from baseline to day 28 were reported following Nic's Keto diet using blood analysis (units in mmol/L).

  15. Changes to LDL-Cholesterol From Baseline to Day 28 Following Nic's Keto Diet

    Time frame: 28 days

    Changes to LDL-cholesterol from baseline to day 28 were reported following Nic's Keto diet using blood analysis (units in mmol/L).

  16. Changes to Total Cholesterol From Baseline to Day 56 Following Nic's Keto Diet

    Time frame: 56 days

    Changes to total cholesterol from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L).

  17. Changes to Triglyceride Level From Baseline to Day 56 Following Nic's Keto Diet

    Time frame: 56 days

    Changes to triglyceride level from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L).

  18. Changes to HDL-Cholesterol From Baseline to Day 56 Following Nic's Keto Diet

    Time frame: 56 days

    Changes to HDL-Cholesterol from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L).

  19. Changes to LDL-Cholesterol From Baseline to Day 56 Following Nic's Keto Diet

    Time frame: 56 days

    Changes to LDL-Cholesterol from baseline to day 56 were reported following Nic's Keto diet using blood analysis (units in mmol/L).

  20. Changes to Total Cholesterol From Baseline to Day 84 Following Nic's Keto Diet

    Time frame: 84 days

    Changes to total cholesterol from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L).

  21. Changes to Triglyceride Level From Baseline to Day 84 Following Nic's Keto Diet

    Time frame: 84 days

    Changes to triglyceride level from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L).

  22. Changes to HDL-Cholesterol From Baseline to Day 84 Following Nic's Keto Diet

    Time frame: 84 days

    Changes to HDL-Cholesterol from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L).

  23. Changes to LDL-Cholesterol From Baseline to Day 84 Following Nic's Keto Diet

    Time frame: 84 days

    Changes to LDL-Cholesterol from baseline to day 84 were reported following Nic's Keto diet using blood analysis (units in mmol/L).

  24. Changes to Total Cholesterol From Baseline to Day 112 Following Nic's Keto Diet

    Time frame: 112 days

    Changes to total cholesterol from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L).

  25. Changes to Triglyceride Level From Baseline to Day 112 Following Nic's Keto Diet

    Time frame: 112 days

    Changes to triglyceride level from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L).

  26. Changes to HDL-Cholesterol From Baseline to Day 112 Following Nic's Keto Diet

    Time frame: 112 days

    Changes to HDL-Cholesterol from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L).

  27. Changes to LDL-Cholesterol From Baseline to Day 112 Following Nic's Keto Diet

    Time frame: 112 days

    Changes to LDL-Cholesterol from baseline to day 112 were reported following Nic's Keto diet using blood analysis (units in mmol/L).

  28. Changes to Total Cholesterol From Baseline to Day 140 Following Nic's Keto Diet

    Time frame: 140 days

    Changes to total cholesterol from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L).

  29. Changes to Triglyceride Level From Baseline to Day 140 Following Nic's Keto Diet

    Time frame: 140 days

    Changes to triglyceride level from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L).

  30. Changes to HDL-Cholesterol From Baseline to Day 140 Following Nic's Keto Diet

    Time frame: 140 days

    Changes to HDL-Cholesterol from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L).

  31. Changes to LDL-Cholesterol From Baseline to Day 140 Following Nic's Keto Diet

    Time frame: 140 days

    Changes to LDL-Cholesterol from baseline to day 140 were reported following Nic's Keto diet using blood analysis (units in mmol/L).

  32. Changes to HbA1c From Baseline to Day 140 Following Nic's Keto Diet

    Time frame: 140 days

    Changes to HbA1c were reported at baseline and compared to day 140 following Nic's Keto Diet.

  33. Changes to Fasting Glucose From Baseline to Day 140 Following Nic's Keto Diet

    Time frame: 140 days

    Changes to fasting glucose were reported at baseline and compared to day 140 following Nic's Keto Diet.

  34. Changes to Free Tri-iodothyronine (T3) From Baseline to Day 140 Following Nic's Keto Diet

    Time frame: 140 days

    Changes to free tri-iodothyronine (T3) were reported at baseline and compared to day 140 following Nic's Keto Diet.

  35. Changes to Weight From Baseline to Day 70 Following Nic's Keto Diet

    Time frame: 70 days

    Changes to weight were reported from baseline and compared to day 70 following Nic's Keto Diet.

  36. Changes to Weight From Baseline to Day 140 Following Nic's Keto Diet

    Time frame: 140 days

    Changes to weight were reported from baseline and compared to Day 140 following Nic's Keto Diet.

  37. Changes to Systolic Blood Pressure From Baseline to Day 70 Following Nic's Keto Diet

    Time frame: 70 days

    Changes to systolic blood pressure were reported from baseline and compared to Day 70 following Nic's Keto Diet.

  38. Changes to Diastolic Blood Pressure From Baseline to Day 28 Following Nic's Keto Diet

    Time frame: 28 days

    Changes to diastolic blood pressure were reported from baseline and compared to Day 28 following Nic's Keto Diet.

  39. Changes to Diastolic Blood Pressure From Baseline to Day 56 Following Nic's Keto Diet

    Time frame: 56 days

    Changes to diastolic blood pressure were reported from baseline and compared to Day 56 following Nic's Keto Diet.

  40. Changes to Diastolic Blood Pressure From Baseline to Day 70 Following Nic's Keto Diet

    Time frame: 70 days

    Changes to diastolic blood pressure were reported from baseline and compared to Day 70 following Nic's Keto Diet.

  41. Changes to Diastolic Blood Pressure From Baseline to Day 84 Following Nic's Keto Diet

    Time frame: 84 days

    Changes to diastolic blood pressure were reported from baseline and compared to Day 84 following Nic's Keto Diet.

  42. Changes to Diastolic Blood Pressure From Baseline to Day 112 Following Nic's Keto Diet

    Time frame: 112 days

    Changes to diastolic blood pressure were reported from baseline and compared to Day 112 following Nic's Keto Diet.

  43. Changes to Diastolic Blood Pressure From Baseline to Day 140 Following Nic's Keto Diet

    Time frame: 140 days

    Changes to diastolic blood pressure were reported from baseline and compared to Day 140 following Nic's Keto Diet.

Other outcomes

  1. Number of Pre-emergent and Post-emergent Adverse Events

    Time frame: 140 days

    Number of pre-emergent and post-emergent adverse events (AEs)

  2. Number of Participants With Abnormal Electrocardiogram (ECG) Readings After 70 Days Following Nic's Keto Diet

    Time frame: 70 days

    ECG reports will be analysed after 70 days of following Nic's Keto Diet and compared to baseline. All ECGs will be assessed by the Qualified Investigator on a case-by-case basis to determine if they were normal or abnormal based on the full clinical picture and patient details. Number of participants with clinically relevant abnormal ECGs will be recorded.

  3. Number of Participants With Abnormal Electrocardiogram (ECG) Readings After 140 Days Following Nic's Keto Diet

    Time frame: 140 days

    ECG reports will be analysed after 140 days of following Nic's Keto Diet and compared to baseline. All ECGs will be assessed by the Qualified Investigator on a case-by-case basis to determine if they were normal or abnormal based on the full clinical picture and patient details. Number of participants with clinically relevant abnormal ECGs will be recorded.

  4. Change in Heart Rate After 140 Days of Following Nic's Keto Diet

    Time frame: 140 days

    Changes in heart rate after 140 days of following Nic's Keto Diet and compared to baseline.

  5. Change in Body Mass Index (BMI) After 140 Days of Following Nic's Keto Diet

    Time frame: 140 days

    Change in Body Mass Index (BMI) after 140 days of following Nic's Keto Diet compared to baseline.

  6. Change in Alanine Aminotransferase (ALT) After 140 Days of Following Nic's Keto Diet

    Time frame: 140 days

    Change in alanine aminotransferase (ALT) after 140 days of following Nic's Keto Diet compared to baseline.

  7. Change in Aspartate Aminotransferase (AST) After 140 Days of Following Nic's Keto Diet

    Time frame: 140 days

    Change in aspartate aminotransferase (AST) after 140 days of following Nic's Keto Diet compared to baseline.

  8. Change in Total Bilirubin After 140 Days of Following Nic's Keto Diet

    Time frame: 140 days

    Change in total bilirubin after 140 days of following Nic's Keto Diet compared to baseline.

  9. Change in Creatinine After 140 Days of Following Nic's Keto Diet

    Time frame: 140 days

    Change in creatinine after 140 days of following Nic's Keto Diet compared to baseline.

  10. Change in Sodium Electrolyte Levels After 140 Days of Following Nic's Keto Diet

    Time frame: 140 days

    Change in sodium electrolyte levels after 140 days of following Nic's Keto Diet compared to baseline.

  11. Change in Potassium Electrolyte Levels After 140 Days of Following Nic's Keto Diet

    Time frame: 140 days

    Change in potassium electrolyte levels after 140 days of following Nic's Keto Diet

  12. Change in Chloride Electrolyte Levels After 140 Days of Following Nic's Keto Diet

    Time frame: 140 days

    Change in chloride electrolyte levels after 140 days of following Nic's Keto Diet compared to baseline.

  13. Change in Phosphorus Electrolyte Levels After 140 Days of Following Nic's Keto Diet

    Time frame: 140 days

    Change in phosphorus electrolyte levels after 140 days of following Nic's Keto Diet compared to baseline.

  14. Change in Estimated Glomerular Filtration Rate (eGFR) After 140 Days of Following Nic's Keto Diet

    Time frame: 140 days

    Change in estimated glomerular filtration rate (eGFR) after 140 days of following Nic's Keto Diet compared to baseline.

  15. Change in Amount of Neutrophils After 140 Days of Following Nic's Keto Diet

    Time frame: 140 days

    Change in amount of neutrophils after 140 days of following Nic's Keto Diet compared to baseline.

  16. Change in Amount of Lymphocytes After 140 Days of Following Nic's Keto Diet

    Time frame: 140 days

    Change in amount of lymphocytes after 140 days of following Nic's Keto Diet compared to baseline.

  17. Change in Amount of Monocytes After 140 Days of Following Nic's Keto Diet

    Time frame: 140 days

    Change in amount of monocytes after 140 days of following Nic's Keto Diet compared to baseline.

  18. Change in Amount of Eosinophils After 140 Days of Following Nic's Keto Diet

    Time frame: 140 days

    Change in amount of eosinophils after 140 days of following Nic's Keto Diet compared to baseline.

  19. Change in Amount of Basophils After 140 Days of Following Nic's Keto Diet

    Time frame: 140 days

    Change in amount of basophils after 140 days of following Nic's Keto Diet compared to baseline.

  20. Change in Red Blood Cell (RBC) Count After 140 Days of Following Nic's Keto Diet

    Time frame: 140 days

    Change in red blood cell (RBC) count after 140 days of following Nic's Keto Diet compared to baseline.

  21. Change in Hemoglobin Levels After 140 Days of Following Nic's Keto Diet

    Time frame: 140 days

    Change in hemoglobin levels after 140 days of following Nic's Keto Diet compared to baseline.

  22. Change in Hematocrit Levels After 140 Days of Following Nic's Keto Diet

    Time frame: 140 days

    Change in hematocrit levels after 140 days of following Nic's Keto Diet compared to baseline.

  23. Change in Platelet Count After 140 Days of Following Nic's Keto Diet

    Time frame: 140 days

    Change in platelet count after 140 days of following Nic's Keto Diet compared to baseline.

  24. Change in Mean Corpuscular Volume (MCV) After 140 Days of Following Nic's Keto Diet

    Time frame: 140 days

    Change in mean corpuscular volume (MCV) after 140 days of following Nic's Keto Diet compared to baseline.

  25. Change in Mean Corpuscular Hemoglobin (MCH) After 140 Days of Following Nic's Keto Diet

    Time frame: 140 days

    Change in mean corpuscular hemoglobin (MCH) after 140 days of following Nic's Keto Diet compared to baseline.

  26. Change in Mean Corpuscular Hemoglobin Concentration (MCHC) After 140 Days of Following Nic's Keto Diet

    Time frame: 140 days

    Change in mean corpuscular hemoglobin concentration (MCHC) after 140 days of following Nic's Keto Diet compared to baseline.

  27. Change in Red Cell Distribution Width (RDW) After 140 Days of Following Nic's Keto Diet

    Time frame: 140 days

    Change in red cell distribution width (RDW) after 140 days of following Nic's Keto Diet compared to baseline.

  28. Change in Mean Platelet Volume (MPV) After 140 Days of Following Nic's Keto Diet

    Time frame: 140 days

    Change in mean platelet volume (MPV) after 140 days of following Nic's Keto Diet compared to baseline.

Sponsors and collaborators

Lead sponsor

TRC GEN+ managed by Trans Russian co Cy

Other

Collaborators

  • KGK Science Inc.

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 12, 2019
Registry last updated
May 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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