Skip to main content
OpenTrials
Completed

NCT Number: NCT00476125

Effects of Dietary Manipulation on Metabolism in Healthy Adults

This study will examine the potential changes in the blood levels of a recently discovered metabolic regulator in response to changes in diet in healthy adults. Our hypothesis is that in healthy adults key regulatory factors involved in lipid oxidation will respond to changes in diet, particularly fasting and diet-induced ketosis.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Metabolic Regulation Behavior Fasting Feeding Behavior Ketogenic Diet

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

There is scant data regarding the metabolic events that occur in humans during ketosis which may be brought about by fasting or ingestion of diets low in carbohydrate.

We aim to employ both fasting and dietary manipulation in order to bring about a ketotic state in healthy human adults. During the study blood levels of key metabolic regulators will be monitored 1) during a 16 hour fast followed by re-feeding and 2) during dietary induction of ketosis followed by re-feeding with a standard meal.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women ages 18-60
  • BMI 21-28 kg/m2
  • Stable weight (variation < 3 kg within 6 months of screening visit)
  • Ability to give informed consent
  • Ability to follow verbal and written instructions in English
  • Use of medically approved form of contraception (monophasic oral contraception, intra uterine device, surgical sterilization or 2 combined barrier methods)

Exclusion criteria

  • Type 1 or type 2 diabetes mellitus diagnosed according to American Diabetes Association criteria
  • Coronary heart disease (history of myocardial infarction, unstable angina pectoris, or congestive heart failure)
  • Uncontrolled hypertension (BP > 150/90 mmHg on or off antihypertensive medication)
  • Dyslipidemia
  • Tobacco, marijuana or intravenous drug use
  • Shift workers (night shift or alternating day/night shifts)
  • Recent weight loss (> 3 kg within 6 months of the screening visit)
  • Gastroparesis
  • Inflammatory bowel disease
  • Malignancy treated with chemotherapy within the past 3 years
  • History of pancreatitis
  • Depression or psychosis
  • Renal insufficiency (creatinine clearance < 50 ml/min)
  • Transaminases > 2x above the normal range
  • Known liver disease
  • Pregnancy within 6 months of the screening visit
  • Lactation
  • Failure to use medically approved contraceptive methods
  • History of an eating disorder (anorexia, bulimia or laxative abuse)
  • History of surgery for the treatment of obesity (gastric banding, gastric bypass, gastric stapling)
  • New diagnosis of hypo or hyperthyroidism within 1 year of screening visit
  • History of alcohol abuse within the past 5 years
  • Seizure disorder
  • Gout
  • Kidney stones

Treatment and study plan

Dietary manipulation ketogenic diet

Behavioral

Subjects will consume a ketogenic diet for 3 days.

Dietary Manipulation - 12 day ketogenic diet

Behavioral

Subjects will consume a ketogenic diet for 12 days.

16 Hour Fast

Behavioral

Subjects will fast for 16 hours.

Primary outcomes

  1. Changes in circulating plasma levels of key metabolic regulators

    Time frame: 1 week

Secondary outcomes

  1. A secondary outcome is change in energy expenditure with diet-induced ketosis.

    Time frame: 1 week

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Important dates

Study start
2008
Primary completion
2023
Study completion
2023
First posted
May 21, 2007
Registry last updated
Aug 14, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.