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The Energy Balance Study

Energy and Appetite Regulation by Low CHO Diets

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01029483
Acronym
EBS
Enrollment
39
Registered
2009-12-10
Start date
2005-09-30
Completion date
2009-06-30
Last updated
2009-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Obesity, Weight loss, low carbohydrate diets, high complex carbohydrate diets, Healthy adults, Body composition, Energy Expenditure

Brief summary

Very low carbohydrate diets and high-complex carbohydrate, low-fat diets are popular weight-loss methods in the United States. The purpose of the Energy Balance Study is to explore how extreme differences in diet affect eating behaviors, activity and calorie-use, and body composition. We will conduct a controlled feeding study (all food will be provided for the duration of the study) in which obese adults will be randomly assigned to one of three dietary groups: a low-carbohydrate-eat as much as you like diet, a high-carbohydrate-eat as much as you like diet, or a high-carbohydrate-calorie-restricted diet. The low-carbohydrate diet will be modeled after the Induction Phase of the Atkins Diet. The high carbohydrate diet will be based on the Dietary Approaches to Stop Hypertension (DASH) diet. During the first 3 weeks, participants will eat a typical diet adjusted so that they neither gain or lose weight. Then, for 6 weeks, they will eat their assigned research diet. Resting calorie use and body composition measurements will be taken at the end of week 2 and week 9. Frequent blood sampling for 24 hours will be done through a catheter (tube) placed in an arm vein at the end of weeks 2 and week 9 and for 12 hours at the end of week 3. Change in body composition, activity and energy expenditure, and blood components known to influence eating behavior will be measured under typical diet conditions and after one-day and 6 weeks of the research diet.

Interventions

OTHERLow carbohydrate diet

Ad libitum low carbohydrate diet (\<28g carbohydrate/day). Participants provided with research diet at 120% of estimated energy needs for weight maintenance and allowed to eat as much or as little of the food desired.

OTHERHigh-carbohydrate ad libitum intervention

Participants provided with a high complex carbohydrate diet (55% carbohydrate, 18% protein, and 27% fat) at 120% of estimated energy needs for weight maintenance and allowed to eat as much or as little of the foods provided as desired

OTHERHigh carbohydrate diet-energy matched intervention

Participants provided a high complex carbohydrate diet (55% carbohydrate, 18% protein, and 27% fat) at \ 70% of estimated energy needs to maintain weight. Participants required to eat all food provided and nothing else.

Sponsors

Kaiser Permanente
CollaboratorOTHER
Oregon Health and Science University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* BMI; 30-50 kg/m2 * Age at least 21 years * Relative good health

Exclusion criteria

* Major debilitating mental or physical illness that would interfere with participation * Renal or hepatic disease, diabetes * History of gallbladder disease/removal * Hyper-or hypothyroidism * Poorly controlled hypertension * Use of lipid lowering medications * Pregnancy or lactation * Current excessive use of alcohol * Current/recent chronic use of tobacco

Design outcomes

Primary

MeasureTime frame
weightloss6 weeks

Secondary

MeasureTime frame
weight regulation hormones (insulin, leptin, ghrelin, GLP-1, PYY)6 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026