ObesityKAMELNCT03696966
KU Alternate Meal Energy Level Study
A study testing Low-Calorie Diet and Intermittent Very-Low Calorie Diet in people with Obesity and Weight Loss, run by University of Kansas Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Obesity, Weight Loss
- What is being tested?
- Low-Calorie Diet and Intermittent Very-Low Calorie Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2018to 1 Nov 2018
- Phase
- Interventional
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
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.
Read the detailed description
The purpose of this study is to provide evidence for the feasibility of an alternative weight control strategy by comparing two diets to see how intermittent calorie restriction compares to continuous or daily calorie restriction for weight loss in 35 adults with overweight or obesity. These diets will be incorporated into a comprehensive and intensive weight management program involving weekly health education meetings, regular diet and physical activity tracking, and feedback from a registered dietitian.
Each intervention includes 3 months of weight loss and 3 months of weight maintenance.
Group 1: Follow a low-calorie diet every day (1,200 - 1,500 calories daily)
Group 2: Follow an intermittent very-low calorie diet (500-800 calories). Participants in this group will alternate between days of 500-800 calories and days of structured eating using healthy eating principles.
- Conditions
- Obesity, Weight Loss
- Being tested
- Portion-Controlled Meals, Low-Calorie Diet, Intermittent Very-Low Calorie Diet
- Keywords
- weight management, obesity, very-low calorie diet, intermittent diet
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portion-Controlled MealsDietary supplement
Increase dietary structure using portion-controlled meals (PCM)
Low-Calorie DietBehavioural
Restrict calorie intake daily
Intermittent Very-Low Calorie DietBehavioural
Also called Intermittent Fasting
Severely restrict calorie intake intermittently
| Study group | Role | What they receive |
|---|---|---|
| Continuous Calorie Restriction | Active comparator | Daily calorie restriction: follow low-calorie diet (1,200-1,500 calories) daily using portion-controlled meals Receives: 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 Receives: Dietary Supplement: Portion-Controlled Meals; Behavioral: Intermittent Very-Low Calorie Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight (lbs, % change from baseline)
Change in absolute (lbs) and relative (%) weight from baseline to the end of the intervention (24 weeks)
Measured: 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
Measured: Change from baseline to 24 weeks
Secondary outcomes (3)
Program adherence
Compliance to intervention protocol; adherence = (# attained / # expected)*100
Measured: weekly through study completion (24 weeks)
Nutrition-related quality of life
Assessed via questionnaire; higher scores indicate greater nutrition-related quality of life.
Measured: baseline, week 12, week 24
Dietary restraint
Assessed via three-factor eating questionnaire with three component scores for cognitive restraint, disinhibition, hunger)
Measured: baseline, week 12, week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start16 Jan 2018
- Primary completion4 Oct 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Debra K. Sullivan, PhD, RD, University of Kansas Medical Center
- Investigators
- Debra Sullivan, PhD, RD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03696966
- Sponsor's protocol ID
- IRB_STUDY00141322
- Acronym
- KAMEL
- Status last verified
- Jan 2019
- First submitted
- 26 Sep 2018
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KU Alternate Meal Energy Level Study
- ClinicalTrials.gov ID
- NCT03696966
- Acronym / sponsor ID
- KAMEL / IRB_STUDY00141322
- Conditions
- Obesity, Weight Loss
- Keywords
- weight management, obesity, very-low calorie diet, intermittent diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 16 Jan 2018 (actual)
- Primary completion
- 4 Oct 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 5 Oct 2018 (actual)
- 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.
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.
Detailed description
The purpose of this study is to provide evidence for the feasibility of an alternative weight control strategy by comparing two diets to see how intermittent calorie restriction compares to continuous or daily calorie restriction for weight loss in 35 adults with overweight or obesity. These diets will be incorporated into a comprehensive and intensive weight management program involving weekly health education meetings, regular diet and physical activity tracking, and feedback from a registered dietitian.
Each intervention includes 3 months of weight loss and 3 months of weight maintenance.
Group 1: Follow a low-calorie diet every day (1,200 - 1,500 calories daily)
Group 2: Follow an intermittent very-low calorie diet (500-800 calories). Participants in this group will alternate between days of 500-800 calories and days of structured eating using healthy eating principles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Calorie Restriction | Active comparator | Dietary Supplement: Portion-Controlled Meals, Behavioral: Low-Calorie DietDaily calorie restriction: follow low-calorie diet (1,200-1,500 calories) daily using portion-controlled meals |
| Intermittent Very-Low Calorie Diet | Experimental | Dietary Supplement: Portion-Controlled Meals, Behavioral: Intermittent Very-Low Calorie DietIntermittent Restriction: follow very-low calorie diet (500-800) with portion-controlled meals three days per week and structured healthy eating on other days |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Portion-Controlled MealsIncrease dietary structure using portion-controlled meals (PCM) | Dietary supplement | Continuous Calorie Restriction, Intermittent Very-Low Calorie Diet |
| Low-Calorie DietRestrict calorie intake daily | Behavioural | Continuous Calorie Restriction |
| Intermittent Very-Low Calorie DietAlso: Intermittent FastingSeverely restrict calorie intake intermittently | Behavioural | Intermittent Very-Low Calorie Diet |
Primary outcome
Weight (lbs, % change from baseline)
Time frame: Change from baseline to 24 weeks
Change in absolute (lbs) and relative (%) weight from baseline to the end of the intervention (24 weeks)
Body composition
Time frame: Change from baseline to 24 weeks
Change in absolute (g) and relative (%) fat mass and fat-free mass from baseline to 24 weeks
3 secondary outcomes
Program adherence
Time frame: weekly through study completion (24 weeks)
Nutrition-related quality of life
Time frame: baseline, week 12, week 24
Dietary restraint
Time frame: baseline, week 12, week 24
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 22 Jan 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
Recruiting
Diet Order Effects of Low Fat vs. Low Carb Diets on Body Fat Change
Overweight, Obesity
RecruitingPhase 1
Evaluate the Safety and Tolerability of Multiple Doses of JMT206 Injection in Obese Participants
Valid MeSH Conditiongs
Not yet recruiting
Prospective Evaluation of Recombinant Pbserum Plus® and Pbserum HA 2.0® in Aesthetic and Regenerative Bioremodeling
Skin Laxity, Localized Adiposity
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.
Debra Sullivan, PhD, RD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Calorie Diet and Intermittent Very-Low Calorie Diet in people with Obesity and Weight Loss, run by University of Kansas Medical Center 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 22 Jan 2019. 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.
What does the primary outcome measure?
Weight (lbs, % change from baseline) (time frame: Change from baseline to 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2019.