HealthyNCT00016848
Effects of Dietary Carbohydrate and Fat on Hormones
An observational study of Healthy and Deficiency Disease, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Healthy, Deficiency Disease
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2001to May 2003
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Ages 18-40.
- Men and women.
- BMI 30-34.9 kg/m2.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Child Health and Human Development (NICHD)
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the detailed description
Caloric restriction triggers a number of homeostatic endocrine responses including suppression of leptin, gonadotropins, sex steroids, thyroid hormones, insulin and insulin like growth factors (IGFs) and elevation of growth hormone (GH) and cortisol. Some of these effects may be disadvantageous in terms of achieving loss of adipose tissue. There is little information on the role of specific macronutrients in the regulation of these important endocrine responses to food restriction. The present study aims to determine if dietary carbohydrate and/or lipid composition has significant effects on these hormonal regulators of body composition and metabolism, independent of total calorie supply. This will be achieved by comparing the short-term effects of isocaloric, weight maintenance diets restricted in either fat or carbohydrate with a standard balanced diet. Protein contribution as well as calorie content will be held constant in the 3 diets. Study subjects will be obese women and men (BMI 30-34.9 kg/m2) aged 18-40 years. Major study outcome parameters include: leptin, gonadotropin, GH and cortisol secretory dynamics; sex steroid, IGF, fasting insulin and glucose levels.
- Conditions
- Healthy, Deficiency Disease
- Keywords
- Obesity, Endocrine, Diet, Metabolism, Macronutrients
- Medical subject headings
- Deficiency Diseases, Obesity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2001 (estimated)
- Study startJun 2001
- Study completionMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00016848
- Sponsor's protocol ID
- 010183
- Other IDs
- 01-CH-0183
- Status last verified
- May 2003
- First submitted
- 6 Jun 2001
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
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. doi: 10.1210/jcem.82.5.3947.
PubMed 9141547Ahima RS, Flier JS. Leptin. Annu Rev Physiol. 2000;62:413-37. doi: 10.1146/annurev.physiol.62.1.413.
PubMed 10845097Agus 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. doi: 10.1093/ajcn/71.4.901.
PubMed 10731495
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Dietary Carbohydrate and Fat on Hormone Regulators of Body Composition and Reproduction
- ClinicalTrials.gov ID
- NCT00016848
- Acronym / sponsor ID
- 010183
- Conditions
- Healthy, Deficiency Disease
- Keywords
- Obesity, Endocrine, Diet, Metabolism, Macronutrients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Jun 2001
- Study completion
- May 2003
- First posted
- 7 Jun 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Caloric restriction triggers a number of homeostatic endocrine responses including suppression of leptin, gonadotropins, sex steroids, thyroid hormones, insulin and insulin like growth factors (IGFs) and elevation of growth hormone (GH) and cortisol. Some of these effects may be disadvantageous in terms of achieving loss of adipose tissue. There is little information on the role of specific macronutrients in the regulation of these important endocrine responses to food restriction. The present study aims to determine if dietary carbohydrate and/or lipid composition has significant effects on these hormonal regulators of body composition and metabolism, independent of total calorie supply. This will be achieved by comparing the short-term effects of isocaloric, weight maintenance diets restricted in either fat or carbohydrate with a standard balanced diet. Protein contribution as well as calorie content will be held constant in the 3 diets. Study subjects will be obese women and men (BMI 30-34.9 kg/m2) aged 18-40 years. Major study outcome parameters include: leptin, gonadotropin, GH and cortisol secretory dynamics; sex steroid, IGF, fasting insulin and glucose levels.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Ages 18-40.
- Men and women.
- BMI 30-34.9 kg/m2.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 9141547Aloi 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. doi: 10.1210/jcem.82.5.3947.
- Background: PubMed 10845097Ahima RS, Flier JS. Leptin. Annu Rev Physiol. 2000;62:413-37. doi: 10.1146/annurev.physiol.62.1.413.
- Background: PubMed 10731495Agus 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. doi: 10.1093/ajcn/71.4.901.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Deficiency Disease, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00016848, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.