An Study Investigating Nic's Keto Diet on Cardiovascular Health in Healthy Adults With Mildly Elevated LDL Levels

Study Overview
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Brief Summary
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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.

Official Title
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An Open Label Study to Investigate the Efficacy of Nic's Keto Diet on Cardiovascular Health in Healthy Adults With Mildly Elevated LDL Levels

Conditions
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Ketogenic Dieting, Healthy

Intervention / Treatment
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* Other: Nic's Keto Diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Open-Label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nic's Keto Diet<br> | Other: Nic's Keto Diet<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 140 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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) | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 140 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ketogenic Diet, Nic's keto diet, Cardiovascular health, Elevated LDL levels