Healthy Clinical Trial
Official title:
The Effects of Dietary Carbohydrate and Fat on Hormone Regulators of Body Composition and Reproduction
This study will try to determine if intake of dietary fats or carbohydrates influences the
tendency to gain weight or accumulate body fat. It will examine how the hormones that
regulate weight may change with a shift from a balanced diet to one that is low in fat or
carbohydrate, irrespective of caloric intake.
Men and women between the ages of 18 and 40 years with a body mass index of 30 to 49 kg/m2
may be eligible for this study. Candidates will be screened with a history, physical
examination, blood tests and questionnaires regarding activity, prior diets, and eating
patterns.
Participants will follow two separate diet regimens for 5 days each. The first will be a
balanced diet, and the second will be either a low-fat/high-carbohydrate diet or a
low-carbohydrate/high-fat diet. The diets are not designed to produce weight loss.
Participants will receive all their meals and snacks for the two diets from the National
Institutes of Health and, for the first 3 days of each diet, will be seen as outpatients.
For days 4 and 5 of each diet, they will be admitted to the Clinical Center and will undergo
the following procedures:
- Blood tests - Blood samples will be collected every 30 minutes over a 24-hour period
through an indwelling catheter in the arm. A total of about 15 tablespoons will be
drawn for each of the two diets.
- 24-hour urine collection - One 24 hour urine collection will be done at home the day
before admission to the Clinical Center, and the other will be done during the hospital
stay.
- Urinalysis and pregnancy test - A small urine sample will be taken and women will
provide an additional sample for a pregnancy test.
- Body measurements - Height and weight will be measured using scales. Body fat will be
measured by two methods: skin fold thickness, measured with calipers in 5 separate
places; and body circumference measurements, in which body parts are measured with a
tape measure.
- Bod pod measurement - Proportions of fat and non-fat tissue in body weight are measured
while the participant sits in a capsule-like device for 5 minutes.
- Bioelectric impedance analysis - Proportions of body fat are measured based on
conduction of a small electric current.
- Total body water estimate -The proportion of body weight that is water is determined,
using a method that involves drinking a cup of a special kind of "heavy" water
(deuterium) and then measuring the amount of heavy water in a urine sample taken after
4 hours.
- Exercise - Participants will maintain their usual exercise routine, as it was before
beginning the study.
Status | Completed |
Enrollment | 80 |
Est. completion date | May 2003 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
INCLUSION CRITERIA: Ages 18-40. Men and women. BMI 30-34.9 kg/m2. EXCLUSION CRITERIA: Major medical or psychiatric diagnoses active within the past 3 years. Endocrine diseases like, thyroid disease, DM, pituitary, ovarian/testicular and adrenal problem Acute infections Irregular menstrual cycles (greater than 7 day menses, intervals greater than 35 or less than 21 days) A weight change of greater than 2% within the past 2 months. Use of prescription medications or other drugs/supplements including acetaminophen or alcohol that would, in the judgement of study investigators, interfere with study objectives Major (greater than 3 hours/week) athletic/physical exercise activities. Eating patterns or dietary preferences which would hinder compliance with study diets Tran meridian travel within 2 weeks preceding study periods Inability to comply with the study protocol Pregnancy Anemia. Hemoglobin less than 11.5 for women and less than 12.7 for men. |
N/A
Country | Name | City | State |
---|---|---|---|
United States | National Institute of Child Health and Human Development (NICHD) | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Agus MS, Swain JF, Larson CL, Eckert EA, Ludwig DS. Dietary composition and physiologic adaptations to energy restriction. Am J Clin Nutr. 2000 Apr;71(4):901-7. — View Citation
Ahima RS, Flier JS. Leptin. Annu Rev Physiol. 2000;62:413-37. Review. — View Citation
Aloi JA, Bergendahl M, Iranmanesh A, Veldhuis JD. Pulsatile intravenous gonadotropin-releasing hormone administration averts fasting-induced hypogonadotropism and hypoandrogenemia in healthy, normal weight men. J Clin Endocrinol Metab. 1997 May;82(5):1543-8. — View Citation
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