An interventional study of Low glycemic index diet and Low fat diet in Obesity and Insulin Resistance, sponsored by Boston Children's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-23.
Sponsored by Boston Children's Hospital · Not applicable, Interventional, and Prevention
The aim of this study is to evaluate the effects of three dominant dietary patterns - conventional low-fat, low-glycemic index (GI) and very-low-carbohydrate - on energy metabolism and heart disease risk factors following weight loss in obese young adults in a feeding study
For most of the last half century, reduction in fat intake has been the primary nutritional approach for the prevention and treatment of obesity and cardiovascular disease (CVD). Over the last few years, very low carbohydrate (Atkins-type) diets have achieved great popularity, with publication of several studies suggesting greater weight loss and improvements in CVD risk factors over 3 to 6 months. Recently, a third dietary approach focused on glycemic index (GI) has generated interest. However, few studies have compared the effects of these diets on body weight regulation and risk for CVD. The primary hypotheses of this study are that any diet that lowers the postprandial rise in blood glucose (very-low-carbohydrate or low-GI) will have beneficial effects on the physiological adaptations to weight loss and on some CVD risk factors. However, other CVD risk factors will be adversely affected by a very-low-carbohydrate vs. a low-GI diet. Preliminary data provide strong support for these hypotheses, by showing that resting energy expenditure declines less and CVD risk factors improve more with weight loss on a low-glycemic load diet compared to a conventional low-fat diet. This application proposes a cross-over feeding design to study the effects of three diets following 12.5% weight loss in obese young adult subjects (n = 24, age 18 to 40 years). The diets are: 1) conventional low-fat, with 60% carb, 20% fat, 20% protein; 2) low-GI with 40% carb, 40% fat, 20% protein; and 3) very-low-carbohydrate with 10% carb, 60% fat, 30% protein. The primary outcome is resting energy expenditure (indirect calorimetry). Secondary outcomes include total energy expenditure (doubly labeled water), thermic effect of food (indirect calorimetry), physical activity (accelerometry), insulin resistance and B-cell function (frequently-sampled OGTT), blood lipids, blood pressure and measures of systemic inflammation and coagulopathy. This study should have major public health implications to the millions of Americans currently following diets to decrease body weight and risk for heart disease.
1,960 studies on the registry are indexed under Insulin Resistance; 306 are open to participants now.
This study's enrollment of 24 is below the median of 40 across 1,536 interventional studies indexed under Insulin Resistance.
Browse Insulin Resistance studies →Boston Children's Hospital is the lead sponsor of 598 studies on the registry; 151 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Low glycemic index diet
Other: Low glycemic index diet
Low fat diet
Other: Low fat diet
Very low carbohydrate diet
Other: Very low carbohydrate diet
Feeding protocol, all foods prepared in a metabolic kitchen
Feeding protocol, all foods prepared in a metabolic kitchen
Feeding protocol, all foods prepared in a metabolic kitchen
resting energy expenditure using indirect calorimetry in the fasting state
Time frame: end of each dietary period
insulin resistance assessed by frequently-sampled oral glucose tolerance test
Time frame: end of each dietary period
thyroid function tests
Time frame: end of each dietary period
total energy expenditure using doubly labeled water methodology
Time frame: end of each dietary period
thermic effect of food using indirect calorimetry
Time frame: end of each dietary period
physical activity using accelerometry
Time frame: end of each dietary period
serum lipids
Time frame: end of each dietary period
plasminogen activator inhibitor-1
Time frame: end of each dietary period
C-reactive protein
Time frame: end of each dietary period
blood pressure
Time frame: end of each dietary period
hunger/appetite
Time frame: end of each dietary period
insulin 30 minutes after oral glucose (as an effect modifier)
Time frame: baseline
Core temperature
Time frame: End of each dietary period
secreted frizzle-related protein-4
Time frame: end of each dietary period
heme-oxygenase
Time frame: end of each dietary period
Irisin
Time frame: end of each dietary period
fibroblast growth factor-21
Time frame: end of each dietary period
chemerin
Time frame: end of each dietary period
trimethylamine N-oxide
Time frame: fasting and postprandial, end of each dietary period
alanine aminotransferase
Time frame: end of each dietary period
Uric acid
Time frame: end of each dietary period
insulin
Time frame: fasting and postprandial, end of each dietary period
ghrelin
Time frame: fasting and postprandial, end of each dietary period
gastric inhibitory peptide
Time frame: fasting and postprandial, end of each dietary period
GLP1
Time frame: fasting and postprandial, end of each dietary period
PYY
Time frame: fasting and postprandial, end of each dietary period
Amylin
Time frame: fasting and postprandial, end of each dietary period
Leptin
Time frame: end of each dietary period
Metabolomic analysis
Evaluate the effect of diet on metabolomic profile in plasma, with the aim of assessing dietary adherence and exploring diet-disease mechanisms
Time frame: end of each dietary period
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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