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Completed No phase listed Observational

Effects of Dietary Carbohydrate and Fat on Hormones

ClinicalTrials.gov ID: NCT00016848

Public ClinicalTrials.gov record NCT00016848. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 7, 2026, 5:34 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

The Effects of Dietary Carbohydrate and Fat on Hormone Regulators of Body Composition and Reproduction

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00016848
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Enrollment
80 participants

Conditions and interventions

Interventions

Not listed

Eligibility (public fields only)

Age range
Not listed
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 31, 2001
Primary completion
Not listed
Completion
Apr 30, 2003
Last update posted
Mar 3, 2008

2001 – 2003

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
National Institute of Child Health and Human Development (NICHD) Bethesda Maryland 20892

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00016848, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 3, 2008 · Synced Sep 7, 2026

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The complete protocol, eligibility criteria, and contact information for NCT00016848 live on ClinicalTrials.gov.

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