- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01661426
Weight Loss Diet Study: Low Carb vs Low Fat
Weight Loss Diet Study: Low Carbohydrate vs. Low Fat and Insulin Resistance Status
The traditional weight loss diet recommended by health professionals has been a low-fat, high-carbohydrate, calorie restricted diet. This recommendation has been challenged by a number of alternative dietary strategies, particularly low-carbohydrate diets. In several recent weight loss studies insulin resistant adults had more success with low- vs. high-carbohydrate diets, in contrast to insulin sensitive adults who had either more success or comparable success with the low-fat diets. The investigators enrolled 61 people with a wide range of insulin sensitivity/resistance. After determining their insulin resistance status, the investigators will split them in the middle and randomly assign them to one of four groups for six months: (1) Low-Carbohydrate/Insulin Resistant (LC/IR); (2) Low-Carbohydrate/Insulin Sensitive (LC/IS); (3) Low-Fat/Insulin Resistant (LF/IR); and (4) Low-Fat/Insulin Sensitive (LF/IS) (15 people/group). After 6 months the participants will switch diet for the following 6 months, i.e. those randomized to the Low-Carbohydrate diet will switch to the Low-Fat diet and vice-versa. The primary outcome of this study is to determine whether weight loss success can be increased if one follows the dietary approach appropriately matched to their insulin resistance status. Secondary outcomes include fasting insulin, glucose, lipids, and fatty acid composition.
--------------------------------------------------------------------------------
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The investigators hope to learn whether matching the weight loss diet to one's insulin resistance status will increase weight loss the success. The relevance of these findings is highlighted by the fact that the national recommendations for weight loss are to follow a high-carbohydrate, low-fat diet. This would imply that about half the population has been given the wrong advice in regards to the most successful dietary pattern for weight loss.
Plasma fatty acid composition patterns have been shown to be associated with both insulin resistance and/or carbohydrate intake. As secondary analyses, the investigators will explore: (1) differences in plasma fatty acid composition between insulin sensitive and resistant participants at baseline; (2) the correlations between insulin markers and plasma fatty acid composition at baseline; (3) the interaction between insulin status and diet on 6-month changes in the plasma fatty acid composition; (4) plasma fatty acid composition changes in participants on low fat and low carbohydrate diets after 6 months; and (5) the correlations between changes in insulin markers, dietary components, and plasma fatty acid composition after 6 months.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford University School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age: > or = 18 years of age
- Women: Pre-menopausal (self-report) and <50 years of age
- Men: <50 years of age
- Race/Ethnicity: All
- BMI (body mass index): 28-40 kg/m2 (need to lose >10% body weight to achieve healthy BMI)
- Body weight stable for the last two months, and not actively on a weight loss plan
- No plans to move from the area over the next 14 months
- Available and able to participate in the evaluations and intervention for the study period
- Willing to accept random assignment
- To enhance study generalizability, people on medications not noted below as specific exclusions can participate if they have been stable on such medications for at least three months
- Ability and willingness to give written informed consent
- No known active psychiatric illness
Exclusion Criteria:
- Pregnant, lactating, within 6 months post-partum, or planning to become pregnant in the next 12 months; no menstruation for the previous 12 months
- Diabetes (type 1 and 2) or history of gestational diabetes or on hypoglycemic medications for any other indication
- Prevalent diseases: Malabsorption, renal or liver disease, active neoplasms, recent myocardial infarction, hypertension (except for those stable on hypertensive medications) (<6 months) (patient self-report and, if available, review of labs from primary care provider)
- Smokers (because of effect on weight and lipids)
- History of serious arrhythmias, or cerebrovascular disease
- Uncontrolled hyper- or hypothyroidism (TSH not within normal limits)
- Medications: Lipid lowering, diabetes medications, and those known to affect weight/energy expenditure
- Excessive alcohol intake (self-reported, >3 drinks/day)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Low-Carbohydrate Diet first, then Low-Fat Diet (IR)
Participants who were more insulin resistant based on the median AUC for insulin concentrations measured from OGTT prior to randomization.
|
Counseling/instruction on how to follow a healthy low-carbohydrate diet for 6 months.
One evening class/week for 8 weeks (8 total classes).
Then one class every other week for 8 weeks (4 total classes).
Then one class every four weeks for 8 weeks (2 total classes): 14 evening classes, total.
Counseling/instruction on how to follow a healthy low-fat diet for 6 months.
One evening class/week for 8 weeks (8 total classes).
Then one class every other week for 8 weeks (4 total classes).
Then one class every four weeks for 8 weeks (2 total classes): 14 evening classes, total.
|
Active Comparator: Low-Fat Diet first, then Low-Carbohydrate Diet (IS)
Participants who were more insulin sensitive based on the median AUC for insulin concentrations measured from OGTT prior to randomization.
|
Counseling/instruction on how to follow a healthy low-carbohydrate diet for 6 months.
One evening class/week for 8 weeks (8 total classes).
Then one class every other week for 8 weeks (4 total classes).
Then one class every four weeks for 8 weeks (2 total classes): 14 evening classes, total.
Counseling/instruction on how to follow a healthy low-fat diet for 6 months.
One evening class/week for 8 weeks (8 total classes).
Then one class every other week for 8 weeks (4 total classes).
Then one class every four weeks for 8 weeks (2 total classes): 14 evening classes, total.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in weight
Time Frame: Baseline and 12 months
|
Weight change was calculated as the 12 month value minus the baseline value
|
Baseline and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Fasting Insulin
Time Frame: Baseline and 12 months
|
Fasting insulin change was calculated as the 12 month value minus the baseline value
|
Baseline and 12 months
|
Change in insulin AUC
Time Frame: Baseline and 12 months
|
Insulin area under the curve (AUC) change was calculated as the 12 month value minus the baseline value.
|
Baseline and 12 months
|
Change in Fasting Glucose
Time Frame: Baseline and 12 months
|
Fasting glucose change was calculated as the 12 month value minus the baseline value.
|
Baseline and 12 months
|
Change in LDL-Cholesterol
Time Frame: Baseline and 12 months
|
LDL-cholesterol change was calculated as the 12 month value minus the baseline value.
|
Baseline and 12 months
|
Change in HDL-Cholesterol
Time Frame: Baseline and 12 months
|
HDL-cholesterol change was calculated as the 12 month value minus the baseline value.
|
Baseline and 12 months
|
Change in Triglycerides
Time Frame: Baseline and 12 months
|
Triglycerides change was calculated as the 12 month value minus the baseline value.
|
Baseline and 12 months
|
Change in systolic and diastolic blood pressure
Time Frame: Baseline and 12 months
|
Blood pressure change was calculated as the 12 month value minus the baseline value.
|
Baseline and 12 months
|
Plasma fatty acid composition at baseline
Time Frame: Baseline
|
Comparison of the plasma fatty acid composition between insulin sensitive and resistant participants at baseline.
|
Baseline
|
Correlations between insulin markers and plasma fatty acid composition at baseline.
Time Frame: Baseline
|
Baseline
|
|
Interaction between insulin status and diet on 6-month changes in the plasma fatty acid composition.
Time Frame: 6 months
|
6 months
|
|
Comparison of plasma fatty acid composition changes in participants on low fat and low carbohydrate diets after 6 months.
Time Frame: Baseline and 6 months
|
Baseline and 6 months
|
|
Correlations between changes in insulin markers, dietary components, and plasma fatty acid composition after 6 months.
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christopher D Gardner, PhD, Stanford University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SU-07262012-10669
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Fundació Sant Joan de DéuNot yet recruitingObesity, Childhood | Obesity, AdolescentSpain
-
Consorcio Centro de Investigación Biomédica en...Maimónides Biomedical Research Institute of Córdoba; Instituto de Salud Carlos... and other collaboratorsActive, not recruiting
-
University of HoustonBaylor College of MedicineCompleted
Clinical Trials on Low-Carbohydrate Diet
-
Uppsala UniversityCompleted
-
University of SurreyBritish Heart FoundationCompleted
-
Yale UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)RecruitingType1diabetes, Low Carbohydrate DietUnited States
-
University Hospital, MotolCzech Academy of SciencesRecruiting
-
Baylor UniversityCompleted
-
UCSF Benioff Children's Hospital OaklandNational Cattlemen's Beef AssociationCompletedHealthy | Cardiovascular Disease | Atherogenic DyslipidemiaUnited States
-
University of British ColumbiaMedtronicCompleted
-
Haukeland University HospitalUniversity of BergenCompleted
-
Vårdcentralen LyckornaCompleted
-
Brigham and Women's HospitalBoston Children's Hospital; Boston Medical Center; Nutrition Science Initiative; New Balance Foundation and other collaboratorsCompleted