Set 9 for Obesity

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
NIDDK, Phoenix, Phoenix, AZ
Obesity+2 More
+150% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein - DietarySupplement
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

Background: Diet-induced thermogenesis (DIT) is the amount of energy one s body uses to eat food, absorb the nutrients from the food, and process those nutrients. Researchers would like to understand more about how changing the balances of protein, fat, carbohydrates, and total calories in the diet can affect DIT. Objective: To learn how different diets can change a person s DIT. Eligibility: Healthy people aged 18 to 60 years who have not intentionally lost weight in the past 6 months. Design: Participants will stay in a clinic for about 34 days. They will eat only the food provided. They will receive 8 different diets during the study, including 7 test diets. Participants will undergo multiple tests. They will be screened with blood and urine tests and a test of their heart function. During the first few days: Their waist, thigh, and neck circumference will be measured. They will have a DXA scan: They will lie on a padded table for about 20 minutes while an instrument measures the amount of fat in their body. They will be tested for diabetes. They will answer questionnaires about topics including eating behavior, hunger, and stress. Throughout the study: Their weight will be measured daily. Blood tests will be repeated. They will stay in a metabolic chamber a total of 9 times. They will remain in a closed room for 24 hours while researchers monitor the room temperature and levels of oxygen and carbon dioxide. Participants will collect all their urine for each 24-hour period.

Eligible Conditions

  • Healthy Subjects (HS)
  • Normal Physiology
  • Obesity

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: 34 days

34 days
24 hour energy expenditure (24h EE)
Diet Induced Thermogenesis
FGF 21
Ghrelin
Psychosocial Assessment
Substrate Oxidation
Sympathetic nervous system activity

Trial Safety

Trial Design

10 Treatment Groups

Set 9
1 of 10
Set 8
1 of 10
Set 7
1 of 10
Set 2
1 of 10
Set 3
1 of 10
Set 4
1 of 10
Set 5
1 of 10
Set 6
1 of 10
Set 10
1 of 10
Set 1
1 of 10
Active Control

120 Total Participants · 10 Treatment Groups

Primary Treatment: Set 9 · No Placebo Group · N/A

Set 9ActiveComparator Group · 7 Interventions: +150% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein, fasting, -50% of energy balance requirements. 50% of calories from carbohydrates, 20% from protein, and 30% from fat, +150% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat, +200% of dietary requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat, +200% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein, -25% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat · Intervention Types: DietarySupplement, DietarySupplement, DietarySupplement, DietarySupplement, DietarySupplement, DietarySupplement, DietarySupplement
Set 8ActiveComparator Group · 7 Interventions: +150% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein, fasting, -50% of energy balance requirements. 50% of calories from carbohydrates, 20% from protein, and 30% from fat, +150% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat, +200% of dietary requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat, +200% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein, -25% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat · Intervention Types: DietarySupplement, DietarySupplement, DietarySupplement, DietarySupplement, DietarySupplement, DietarySupplement, DietarySupplement
Set 7ActiveComparator Group · 7 Interventions: +150% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein, fasting, -50% of energy balance requirements. 50% of calories from carbohydrates, 20% from protein, and 30% from fat, +150% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat, +200% of dietary requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat, +200% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein, -25% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat · Intervention Types: DietarySupplement, DietarySupplement, DietarySupplement, DietarySupplement, DietarySupplement, DietarySupplement, DietarySupplement
Set 2ActiveComparator Group · 7 Interventions: +150% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein, fasting, -50% of energy balance requirements. 50% of calories from carbohydrates, 20% from protein, and 30% from fat, +150% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat, +200% of dietary requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat, +200% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein, -25% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat · Intervention Types: DietarySupplement, DietarySupplement, DietarySupplement, DietarySupplement, DietarySupplement, DietarySupplement, DietarySupplement
Set 3ActiveComparator Group · 7 Interventions: +150% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein, fasting, -50% of energy balance requirements. 50% of calories from carbohydrates, 20% from protein, and 30% from fat, +150% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat, +200% of dietary requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat, +200% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein, -25% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat · Intervention Types: DietarySupplement, DietarySupplement, DietarySupplement, DietarySupplement, DietarySupplement, DietarySupplement, DietarySupplement
Set 4ActiveComparator Group · 7 Interventions: +150% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein, fasting, -50% of energy balance requirements. 50% of calories from carbohydrates, 20% from protein, and 30% from fat, +150% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat, +200% of dietary requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat, +200% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein, -25% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat · Intervention Types: DietarySupplement, DietarySupplement, DietarySupplement, DietarySupplement, DietarySupplement, DietarySupplement, DietarySupplement
Set 5ActiveComparator Group · 7 Interventions: +150% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein, fasting, -50% of energy balance requirements. 50% of calories from carbohydrates, 20% from protein, and 30% from fat, +150% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat, +200% of dietary requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat, +200% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein, -25% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat · Intervention Types: DietarySupplement, DietarySupplement, DietarySupplement, DietarySupplement, DietarySupplement, DietarySupplement, DietarySupplement
Set 6ActiveComparator Group · 7 Interventions: +150% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein, fasting, -50% of energy balance requirements. 50% of calories from carbohydrates, 20% from protein, and 30% from fat, +150% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat, +200% of dietary requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat, +200% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein, -25% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat · Intervention Types: DietarySupplement, DietarySupplement, DietarySupplement, DietarySupplement, DietarySupplement, DietarySupplement, DietarySupplement
Set 10ActiveComparator Group · 7 Interventions: +150% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein, fasting, -50% of energy balance requirements. 50% of calories from carbohydrates, 20% from protein, and 30% from fat, +150% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat, +200% of dietary requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat, +200% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein, -25% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat · Intervention Types: DietarySupplement, DietarySupplement, DietarySupplement, DietarySupplement, DietarySupplement, DietarySupplement, DietarySupplement
Set 1ActiveComparator Group · 7 Interventions: +150% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein, fasting, -50% of energy balance requirements. 50% of calories from carbohydrates, 20% from protein, and 30% from fat, +150% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat, +200% of dietary requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat, +200% of dietary requirements, 51% of the calories from carbohydrates, 46%, from fat and 3% from protein, -25% of energy balance requirements, 50% of calories from carbohydrates, 20% from protein, and 30% from fat · Intervention Types: DietarySupplement, DietarySupplement, DietarySupplement, DietarySupplement, DietarySupplement, DietarySupplement, DietarySupplement

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 34 days
Closest Location: NIDDK, Phoenix · Phoenix, AZ
Photo of Phoenix 1Photo of Phoenix 2Photo of Phoenix 3
2010First Recorded Clinical Trial
17 TrialsResearching Obesity
18 CompletedClinical Trials

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor
2,094 Previous Clinical Trials
5,051,373 Total Patients Enrolled
392 Trials studying Obesity
1,479,312 Patients Enrolled for Obesity
Tomas Cabeza De BacaPrincipal InvestigatorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Eligibility Criteria

Age 18 - 65 · All Participants · 2 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.