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Metabolism of Low Carbohydrate and Ketogenic Diet

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05071287
Recruitment Status : Active, not recruiting
First Posted : October 8, 2021
Last Update Posted : July 5, 2022
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Study Description
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Brief Summary:
This study will assess the preliminary efficacy of a lifestyle intervention including low-carb/ketogenic diet and exercise, enhanced by self-monitoring through health technologies on weight and diabetes outcomes (Glucose, HbA1c) and diabetic complications (cognitive function, and renal function) in a 6-month randomized clinical trial in 60 overweight/obese adults with or without T2D. Renal function will be assessed via both traditional and novel biomarkers, including novel metabolites and mitochondrial function.

Condition or disease Intervention/treatment Phase
Diabetic Kidney Disease Cognitive Function Weight Loss Diabetic Control Type2 Diabetes Other: mHealth + low-fat diet Other: mHealth + low-carb/ketogenic diet Not Applicable

Detailed Description:

Participants in both groups will receive standardized health education sessions including lifestyle management, blood glucose control, blood pressure control, and prevention of diabetic complications from trained providers who are also investigators of this study. The lifestyle intervention from the evidence-based Group Lifestyle Balance (GLB) program (http://www.diabetesprevention.pitt.edu/index.php/for-the-public/for-health-providers/group-lifestyle-balance-curriculum/) and Look AHEAD intervention (https://www.lookaheadtrial.org) will be modified for this study. Goal for weight loss and physical activity will be set for each participant based on recommendations from GLB and Look AHEAD. Lifestyle intervention will be delivered through interactive digital lessons. Smart phone and mobile health devices will be used for each participant to self-monitor diet, physical activity, weight, glucose level, blood pressure, and blood ketone (if randomized to the low-car/ketogenic diet group).

Control group (mHealth+ low-fat diet group):

The low-fat group will be asked to restrict total calorie and total fat consumption according to the Look AHEAD intervention and MyPlate guidelines, with 26-44% carbs, 10-30% protein, and less than 30% fat.

Intervention group (mHealth+ low-carb/ketogenic diet group):

The low-carb/ketogenic diet group, will have total calorie set according to Look AHEAD intervention, and carb consumption restriction will be set based on recommendations from American Diabetic Association, National Kidney Foundation, and other evidence-based resources. Participants in this group will be asked to consume a low-carb/ketogenic diet. Specially, participants will receive a carbohydrate, protein, and fat intake goal based on 1.5 : 1 ratio (1.5 grams of fat to 1 gram of carbohydrate and protein combined). Daily macronutrient and calorie consumption will be individualized for each participant using ideal body weight as inferred from wrist circumference and activity level. Carbohydrate consumption will be less than 10% (20~50 g), protein 10-20% (1.0~1.2g/kg ideal body weight), and fat 70-80% of total daily energy, respectively. Nutritional ketosis will be reached by consuming such diet (0.5 mmol/L).

All diet intervention materials will be developed by a registered dietitian according to the evidence-based guidelines. The dietitian will also be responsible to any study activities relevant to diet. These activities include but are not limited to responding to some specific diet questions to study participants and health related measurements relevant to diet changes.

An interventionist, under supervision of a registered dietitian, will interact with each participant from both groups at the beginning of the intervention as an introduction visit, and three individual intervention sessions at month 1, 3, and 5. During the introduction visit, the interventionist will set up a personalized weight loss goal and caloric intake goal with the participants. The individual intervention sessions at month 1, 3 and 5 will be arranged to solve the encountered problems regarding diet, weight loss, caloric intake and action planning.

Additional communication through phone call will be used to support patient dietary changes throughout the study based on their self-monitoring information.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomized controlled trial with 2 arms. Randomization will be done in clusters:

  1. overweight/obese adults with type 2 diabetes (T2D) but no chronic kidney disease (CKD)
  2. overweight/obese with T2D without CKD
  3. overweight/obese with early stage CKD
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Precision Metabolic Mechanisms of Low Carbohydrate and Ketogenic Diet
Actual Study Start Date : June 3, 2021
Actual Primary Completion Date : April 30, 2022
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Control Group (mHealth+low-fat diet group)
The low-fat group will be asked to restrict total calorie and total fat consumption according to the Look AHEAD intervention and MyPlate guidelines, with 26-44% carbs, 10-30% protein, and less than 30% fat.
 Other: mHealth + low-fat diet
A restricted total calorie and reduced total fat consumption.
Experimental: Intervention Group (mHealth + low-carbohydrate/ketogenic diet group)
Total calories will be set according to Look AHEAD intervention, and carbohydrate consumption restriction will be set based on recommendations from American Diabetic Association, National Kidney Foundation, and other evidence-based resources. Participants in this group will be asked to consume a low-carb/ketogenic diet. Specially, participants will receive a carbohydrate, protein, and fat intake goal based on 1.5 : 1 ratio (1.5 grams of fat to 1 gram of carbohydrate and protein combined). Daily macronutrient and calorie consumption will be individualized for each participant using ideal body weight as inferred from wrist circumference and activity level. Carbohydrate consumption will be less than 10% (20~50 g), protein 10-20% (1.0~1.2g/kg ideal body weight), and fat 70-80% of total daily energy, respectively. Nutritional ketosis will be reached by consuming such diet (0.5 mmol/L).
 Other: mHealth + low-carb/ketogenic diet
A low-carb/ketogenic diet


Outcome Measures
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Primary Outcome Measures :
  1. Estimated Glomerular Filtration rate (eGFR) [ Time Frame: Baseline to 6 months ]
    Measure of change in eGFR in a blood sample

  2. Albumin-to-Creatinine ratio (ACR) [ Time Frame: Baseline to 6 months ]
    Measure of the change in ACR in urine

  3. Mitochondrial DNA [ Time Frame: Baseline to 6 months ]
    Measure of change of mitochondrial function using blood and urine levels

  4. Montreal Cognitive Assessment (MoCA) [ Time Frame: Baseline to 6 months ]
    A one page, 30-point test administered to test cognition. MoCA scores range between 0 and 30. A score of 26 or over is considered to have no cognitive impairment, while lower scores imply more cognitive impairment. Tasks include short term memory recall, visuospatial ability tests, attention, concentration and working memory evaluation and language skills.

  5. Gut Metabolomics [ Time Frame: Baseline to 6 months ]
    Measure of changes of gut metabolites using mass spectroscopy


Secondary Outcome Measures :
  1. Glycemic Control [ Time Frame: Baseline to 6 months ]
    Change in glycemic control measured by the change in percentage of glycated hemoglobin in blood


Other Outcome Measures:
  1. Weight Change [ Time Frame: Baseline to 6 months ]
    Measure of weight change that occurred while assigned to the diet

  2. Change in Blood Pressure [ Time Frame: Baseline to 6 months ]
    Measure of blood pressure change that occurs over study period, both systolic and diastolic.

  3. Total blood lipids [ Time Frame: Baseline to 6 months ]
    Measure of change in total blood lipids over the study period

  4. Fecal Metabolomics [ Time Frame: Baseline to 6 months ]
    Measure of changes of fecal metabolites in optional stool sample using mass spectroscopy


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Willing to participate in the study
  2. being 18 and over

  3. For overweight/obese adults (BMI≥25kg/m2)

    1. without self-reported diagnosis of Type 2 Diabetes (T2D) or Chronic Kidney Disease (CKD): Estimated Glomerular Filtration Rate (eGFR)≥90mL/min/1.73m2 and urine albumin to creatinine ratio (ACR)<30mg/g within the past 12 months
    2. with Type 2 Diabetes (T2D) but without Chronic Kidney Disease (CKD): Estimated glomerular filtration rate (eGFR)≥90mL/min/1.73m2 and Albumin-to-Creatinine ratio (ACR)<30mg/g within the past 12 months
    3. with early stage Chronic Kidney Disease (CKD): 60≤eGFR<90mL/min/1.73m2 or 30mg/g ≤ACR< 1000mg/g within the 12 months
  4. can speak and understand English
  5. own a smart phone or tablet that has reliable internet/data access
  6. agree to comply with all study requirements

Exclusion Criteria:

  1. Patients with triglyceride ≥ 500 mg/dL or with Low-Density Lipoprotein Cholesterol≥ 129mg/dL
  2. type 1 diabetes (by self-report)
  3. severe psychiatric disorders deemed by investigators, which might interfere with study procedures (by self-report)
  4. severe chronic conditions (e.g. severe heart disease, renal disease, cognitive impairment, etc.) that would preclude them from participating
  5. unwillingness to sign the consent form and be randomized into a study group
  6. enrollment in other low carb/keto diet or weight loss programs
  7. inability to walk without assistance (by self-report)
  8. under SGLT2 inhibitor treatment
  9. being pregnant or breast feeding (by self-report)
  10. having plans to leave the city or USA for over 2 weeks within 6 months at enrollment
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05071287


Locations
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United States, Texas
University Health System Texas Diabetic Institute
San Antonio, Texas, United States, 78207
UT Health San Antonio School of Nursing
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
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Principal Investigator: Yan Du, PhD MPH RN University of Texas Health San Antonio
More Information
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Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT05071287    
Other Study ID Numbers: HSC20190528H
First Posted: October 8, 2021    Key Record Dates
Last Update Posted: July 5, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The plan to make Individual Participant Data (IPD) available to other researchers has not been decided.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The University of Texas Health Science Center at San Antonio:
Weight loss
Healthy lifestyle intervention
Type 2 Diabetes
Renal function
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Diabetes Mellitus, Type 2
Weight Loss
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Body Weight Changes
Body Weight
Diabetes Complications