Stanford University School of Medicine
Stanford, California, 94305, United States
NCT Number: NCT01661426
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.
--------------------------------------------------------------------------------
Looking for future studies?
Notify Me18 year–50 year
All sexes
Interventional
Not applicable
Stanford, California, 94305, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline and 12 months
Weight change was calculated as the 12 month value minus the baseline value
Time frame: Baseline and 12 months
Fasting insulin change was calculated as the 12 month value minus the baseline value
Time frame: Baseline and 12 months
Insulin area under the curve (AUC) change was calculated as the 12 month value minus the baseline value.
Time frame: Baseline and 12 months
Fasting glucose change was calculated as the 12 month value minus the baseline value.
Time frame: Baseline and 12 months
LDL-cholesterol change was calculated as the 12 month value minus the baseline value.
Time frame: Baseline and 12 months
HDL-cholesterol change was calculated as the 12 month value minus the baseline value.
Time frame: Baseline and 12 months
Triglycerides change was calculated as the 12 month value minus the baseline value.
Time frame: Baseline and 12 months
Blood pressure change was calculated as the 12 month value minus the baseline value.
Time frame: Baseline
Comparison of the plasma fatty acid composition between insulin sensitive and resistant participants at baseline.
Time frame: Baseline
Time frame: 6 months
Time frame: Baseline and 6 months
Time frame: 6 months
Stanford University
Other
Weight Loss Diet Study: Low Carbohydrate vs. Low Fat and Insulin Resistance Status
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.
Published trials that share one or more normalized conditions with this study.
NCT00285844
Body Weight, Body Weight Changes
Stanford, California, United States
View Trial DetailsNCT03685123
Behavior, Body Weight
Greenville, North Carolina, United States
View Trial DetailsNCT00841334
Behavior, Body Weight
Albuquerque, New Mexico, United States
View Trial DetailsNCT03393195
Behavior, Body Weight
San Francisco, California, United States
View Trial Details