Effect of Caloric Restriction & Protein Intake on Metabolism & Anabolic

Status Completed

Clinical Trial Summary

The purpose of this study is to determine if an increased protein intake can attenuate the suppression of metabolic and anabolic hormones during caloric restriction

Clinical Trial Description

1. Preliminary testing

Prior to the study start, participants will be weighed and body composition will be determined using calipermetry (7 sites) and bioelectrical impedance. Peak oxygen uptake (VO2peak) will be assessed using an incremental exercise test on a bicycle ergometer.

2. Randomization

Participants will proceed through each of the following conditions lasting 5 days:

CR-LP: Participants will be restricted to 30 kcal/kg FFM/day and protein intake will be low (0.8 g/kg BW/day).

CR-HP: Participants will be restricted to 30 kcal/kg FFM/day and protein intake will be high (1.7 g/kg BW/day).

CON: Participants will be in energy balance and consume 1.7 g protein/kg BW/day.

3. Diet Prescription

Dietary energy intake will be controlled using clinical products and maltodextrin to meet target energy intakes. Participants will received calcium and Vitamin D supplementation throughout the study.

4. Exercise Prescription

During all conditions, participants will conduct daily supervised exercise on a bicycle ergometer at an exercise intensity of 60% VO2peak. Exercise duration will be adjusted individually such that exercise energy expenditure will amount to 15 kcal/kg FFM/day. Additional exercise and intense physical activity will be prohibited.

5. Assessments

The following assessments will be conducted prior to the start of each condition as well as upon completion of each condition: body weight and composition (impedance), fasting blood draw for assessment of metabolic and anabolic hormones, resting metabolic rate, aerobic fitness (VO2peak), and questionnaires.

6. Washout

Once a participant has completed a study condition, participant will be allowed a washout of at least 14 days to allow protein balance to return to baseline (Hoffer & Forse, 1990). During this time, participants will resume their regular diet and physical activity. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02945410
Study type	Interventional
Source	University of Nebraska Lincoln
Contact
Status	Completed
Phase	N/A
Start date	September 2016
Completion date	February 2019

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04506996` - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2	N/A
Active, not recruiting	`NCT04420936` - Pragmatic Research in Healthcare Settings to Improve Diabetes and Obesity Prevention and Care for Our Program	N/A
Terminated	`NCT03316105` - Effect of T6 Dermatome Electrical Stimulation on Gastroduodenal Motility in Healthy Volunteers	N/A
Completed	`NCT03700736` - The Healthy Moms Study: Comparison of a Post-Partum Weight Loss Intervention Delivered Via Facebook or In-Person Groups	N/A
Active, not recruiting	`NCT04353726` - Knowledge-based Dietary Weight Management.	N/A
Completed	`NCT02948283` - Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia	Phase 1
Completed	`NCT03377244` - Healthy Body Healthy Souls in the Marshallese Population	N/A
Completed	`NCT02877004` - LLLT for Reducing Waste Circumference and Weight	N/A
Active, not recruiting	`NCT04327141` - Low Sugar Protein Pacing, Intermittent Fasting Diet in Men and Women	N/A
Completed	`NCT03929198` - Translation of Pritikin Program to the Community	N/A
Recruiting	`NCT05249465` - Spark: Finding the Optimal Tracking Strategy for Weight Loss in a Digital Health Intervention	N/A
Recruiting	`NCT05942326` - Sleep Goal-focused Online Access to Lifestyle Support	N/A
Completed	`NCT00535600` - Effects of Bariatric Surgery on Insulin
Not yet recruiting	`NCT03601273` - Bariatric Embolization Trial for the Obese Nonsurgical	Phase 1
Active, not recruiting	`NCT04357119` - Common Limb Length in One-anastomosis Gastric Bypass	N/A
Completed	`NCT03139760` - POWERSforID: A Telehealth Weight Management System for Adults With Intellectual Disability	N/A
Completed	`NCT02948517` - Time Restricted Feeding for Weight Loss and Cardio-protection	N/A
Completed	`NCT03210207` - Gastric Plication in Mexican Patients	N/A
Recruiting	`NCT02559479` - A Study to Assess the Effect of a Normal vs. High Protein Diets in Carbohydrates Metabolism in Obese Subjects With Diabetes or Prediabetes	N/A
Completed	`NCT02627105` - The Beef WISE Study: Beef's Role in Weight Improvement, Satisfaction, and Energy	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effect of Caloric Restriction and Protein Intake on Metabolism and Anabolic Sensitivity

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms