KU Alternate Meal Energy Level Study

NCT03696966 | Completed DMC

• 1 other identifier: IRB_STUDY00141322
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Compare intermittent versus continuous calorie restriction to learn more about these eating plans and determine whether they are useful and effective to lose weight and keep it off.

Conditions

Obesity; Weight Loss

Keywords

weight management; obesity; very-low calorie diet; intermittent diet

Outcome Measures

Primary Outcomes (2)

• Weight (lbs, % change from baseline)

  Change in absolute (lbs) and relative (%) weight from baseline to the end of the intervention (24 weeks)

  Change from baseline to 24 weeks

• Body composition

  Change in absolute (g) and relative (%) fat mass and fat-free mass from baseline to 24 weeks

  Change from baseline to 24 weeks

Secondary Outcomes (3)

• Program adherence

  weekly through study completion (24 weeks)

• Nutrition-related quality of life

  baseline, week 12, week 24

• Dietary restraint

  baseline, week 12, week 24

Study Arms (2)

Continuous Calorie Restriction

ACTIVE COMPARATOR

Daily calorie restriction: follow low-calorie diet (1,200-1,500 calories) daily using portion-controlled meals

Dietary Supplement: Portion-Controlled Meals; Behavioral: Low-Calorie Diet

Intermittent Very-Low Calorie Diet

EXPERIMENTAL

Intermittent Restriction: follow very-low calorie diet (500-800) with portion-controlled meals three days per week and structured healthy eating on other days

Dietary Supplement: Portion-Controlled Meals; Behavioral: Intermittent Very-Low Calorie Diet

Interventions

Portion-Controlled Meals DIETARY_SUPPLEMENT

Increase dietary structure using portion-controlled meals (PCM)

Continuous Calorie Restriction; Intermittent Very-Low Calorie Diet

Low-Calorie Diet BEHAVIORAL

Restrict calorie intake daily

Continuous Calorie Restriction

Intermittent Very-Low Calorie Diet BEHAVIORAL

Severely restrict calorie intake intermittently

Also known as: Intermittent Fasting

Intermittent Very-Low Calorie Diet

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21-65 years.
• BMI 25-35. Patients with a BMI less than 25 are not classified as overweight and individuals with a BMI \>35 may require more aggressive weight management strategies.
• Clearance for participation from their PCP.

You may not qualify if:

• Participation in a research project or formal program involving weight loss or exercise in the previous 6 mos., as these proximal experiences may impact the results of this study.
• Participation in a regular exercise program (i.e., \> 500 kcal/wk. of planned activity as estimated by questionnaire \[34\].
• Not weight stable (-/+ 5%) for 6 mos. prior to intake. This will be determined by phone screen and self-report on the health history questionnaire
• Unwilling to be randomized to one of two diet strategies for weight loss.
• Pregnant during the previous 6 mos., lactating, or planned pregnancy in the following 6 mos.
• Serious medical risk (e.g. diabetes, cancer, cardiovascular disease) as determined by the individual's physician via the clearance to participate in the investigation.
• Disordered eating as determined by the Eating Attitudes Test using a score of 20 or greater \[35\]. This score indicates the need for counseling outside the scope of this study.
• Current treatment for psychological problems, or taking psychotropic medications. Addressing psychological problems is outside the scope of this study.
• Medications known to significantly influence weight.
• Adherence to specialized diet regimens (e.g., multiple food allergies, vegan, etc.)
• Do not have access to or independence over grocery shopping and meal preparation (i.e. those in military, college with cafeteria plan, etc.).
• If participants have recently undergone CT (Computed Tomography), PET, fluoroscopic, or nuclear medicine studies within the past year.

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Obesity; Weight Loss

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Debra Sullivan, PhD, RD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: October 5, 2018
• Study Start: January 16, 2018
• Primary Completion: October 4, 2018
• Study Completion: November 1, 2018
• Last Updated: January 22, 2019

Record last verified: 2019-01

Locations

US (1)