Summary
This study will evaluate the effects of dietary carbohydrate and sugar consumption, independent of energy content, on body fatness and metabolism in a rigorous feeding study.
Conditions
Obesity
Recruitment Status
Terminated
Detailed Description
Many people with obesity can lose weight for a few months, but most have difficulty maintaining weight loss over the long term. Extensive research has shown that weight loss elicits biological adaptations - including a decline in energy expenditure and an increase in hunger - that promote weight regain. However, this observation leaves unanswered why average body weight has recently increased among populations that are mostly genetically stable. According to the Carbohydrate-Insulin Model, increased consumption of processed carbohydrates during the low-fat diet era of the last 40 years has raised the average body weight being defended by biological mechanisms on a population basis. Specifically, the investigators hypothesize that diets high in total carbohydrate (with or without added sugar) acting through increased insulin secretion, alter substrate partitioning toward storage in body fat, leading to increased hunger, slowing metabolism, and accumulation of body fat. To test this hypothesis, the investigators plan a randomized-controlled feeding study involving 125 adults with obesity. During the run-in phase, participants will be given a hypocaloric very-low-carbohydrate (VLC) diet, with adjustment of energy intake to produce 15 ± 3% weight loss over 3 to 4 months on an outpatient basis. After weight stabilization, participants will be admitted to a residential center for 13 weeks. During the first 3 weeks, energy intake and expenditure will be closely monitored during weight-loss maintenance. Then, energy intake will be individually "locked" at levels equal to energy expenditure and participants will be administered one of three randomly-assigned test diets for 10 weeks. The test diets include VLC, High Carbohydrate-Low Sugar (HC-LS), and High Carbohydrate-High Sugar (HC-HS).
Eligibility Criteria
Inclusion Criteria:
Aged 18 to 50 years
BMI ≥ 27 kg/m2
Weight ≤ 350 lb
Medical clearance from a primary care provider
Willingness to follow a VLC weight-loss diet
Willingness to reside in a research unit for 3 months and eat/drink only provided study foods and beverages
No major food allergies or aversions
Willingness to obtain seasonal flu shot or provide documentation of flu shot for current flu season (winter/spring cohort only)
Willingness to discuss work options (e.g., remote work) with employer, and make appropriate arrangements prior to the Residential phase.
Exclusion Criteria:
Change in body weight ≥ 10% during prior 6 months
Specialized diets (e.g., for medical or religious reasons)
Chronic use of any medication or dietary supplement that could affect study outcomes (e.g., insulin, metformin, thyroxine)
Current smoking (1 cigarette in the last week)
Greater than moderate alcohol consumption (> 14 drinks/wk) or history of binge drinking (≥5 drinks in 1 day within past 6 months)
Physician diagnosis of a major medical illness or eating disorder
History of kidney stones
Laboratory tests: ALT>2x upper limit; abnormal HgA1c; abnormal TSH; abnormal creatinine; abnormal uric acid (using the male upper limit for both sexes)
Failed criminal offender background check or sex offender background check
Use of recreational drugs
Current diagnosis or history of kidney stones, gout, or gall stones; or removal of gall bladder
Exercise restrictions or at high risk for complications during exercise
Female-specific exclusion criteria:
Menopausal
Any change in birth control medication during the 3 months prior to enrollment
Pregnancy or lactation during the 12 months prior to enrollment, or intent to become pregnant during study participation
Intervention
Intervention Type
Intervention Name
Behavioral
Feeding Study
Phase
Not Applicable
Gender
All
Min Age
18 Years
Max Age
50 Years
Download Date
June 18, 2021
Principal Investigator
David S. Ludwig, MD, PhD
Primary Contact Information
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: