ObesityAltER2022NCT05213520
Effect of a 4-week Alternate Day Intermittent Energy Restriction Intervention vs Reduced
A study testing Alternate Day Intermittent Energy Restriction and Reduced Calorie Diet in people with Obesity, run by Texas Tech University at 2 sites in United States.
Trial summary
This pilot study is an active control randomized controlled trial with a sample size of 30 that will consist of 2 groups, to evaluate the effects of a one-month alternate day intermittent energy restriction (AltER) intervention on body weight, body composition, resting metabolic rate in college students with obesity… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Alternate Day Intermittent Energy Restriction and Reduced Calorie Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Jan 2022to 5 Nov 2022
- 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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18 -25 years
- Enrolled as full-time college students
- Have a BMI ≥ 30
- Willing and able to give informed consent
- Willing to follow either dietary intervention assigned to them upon randomization.
- Able to come in for all assessment visits.
Who cannot join
- Participants who are currently diagnosed with diabetes mellitus, cardiovascular disease, liver or kidney disease, cancer
- Current severe psychiatric illnesses (e.g. psychosis, schizophrenia, bipolar disorders, depression
- Current suicidal ideation, and recent or past suicide attempts
- History of psychiatric hospitalization (past year).
- History of diagnosed eating disorders such as bulimia nervosa, anorexia nervosa and severe binge eating disorder.
- History of diagnosed substance abuse or alcohol abuse.
Show all 9Show fewer
- Currently on any weight loss diet.
- Having lost in the past 3 months 10% or more of body weight.
- Unwilling or unable to give informed consent.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Texas Tech University - Department of Nutritional Sciences
Lubbock, Texas, 79409
Nutrition and Metabolic Health Initiative
Lubbock, Texas, 79410
About this study
Official title: Effect of a Novel Alternate Day Intermittent Energy Restriction Intervention vs. Standard Reduced Calorie Diet on Body Weight, Body Composition, and Resting Metabolic Rate in College Students With Obesity
This pilot study is an active control randomized controlled trial with a sample size of 30 that will consist of 2 groups, to evaluate the effects of a one-month alternate day intermittent energy restriction (AltER) intervention on body weight, body composition, resting metabolic rate in college students with obesity as compared to a standard reduced calorie diet (RCD). Among the 30 participants, 15 will be randomized into the experimental group that will receive the AltER intervention while the other 15 will be a part of the active control group that will follow a RCD. The study will be conducted at the Texas Tech University Nutrition and Metabolic Health Initiative.
Read the detailed description
This pilot study proposes to investigate the scope and benefits of a novel, hybrid alternate day fasting protocol tailored to the college student lifestyle. This protocol - Alternate Day Intermittent Energy Restriction (AltER) is novel because it proposes to modify the standard ADF regime by increasing energy intake to 40% of calorie needs on fasting days. While this may not be as restrictive as other protocols, it still can help create a significant energy deficit. Additionally, it will provide flexibility by allowing for two consecutive fast days if the individual chooses to. While most dietary interventions can achieve significant weight loss in this short duration we expect that this approach tailored to college lifestyle will be superior to typical dietary restriction.
Subjects will be asked to attend two approximately 90-minute assessment visits (4 weeks apart) at the NMHI facility They will have their height weight and blood pressure measured, fill out questionnaires (attached), and have body composition (BodPod) and resting metabolic rate (Metabolic Cart) measured.
At completion of visit one they are randomly assigned to one of two Diet protocols designed to reduce calories and help them to safely lose weight They will also be asked to respond to a brief (3 questions) email survey weekly.
The AltER diet alternate between full calorie (no restriction) eating days with eating 40% of your daily caloric requirement on the other day. There will be occasional exceptions allowed with maximum of two 40% days in a row (followed by two full days) based on personal schedule with prior PI approval. The RCD will require a reduction of 500-1000 calories below daily energy requirement. The intervention or control diet will be followed for a duration of 4 weeks at the end of which the participants will come in for visit 2 which will follow a similar format like visit 1.
General Aim
To determine the effect of a novel, alternate day intermittent calorie restriction intervention on body weight, fat mass and resting metabolic rate of college students with obesity as compared to a standard reduced calorie diet 3.2.1. Specific Aim 1: To determine the effect of a novel, alternate day intermittent calorie restriction intervention on body weight of college students with obesity as compared to a standard reduced calorie diet.
3.2.1. Specific Aim 2: To determine the effect of a novel, alternate day intermittent calorie restriction intervention on fat mass of college students with obesity as compared to a standard reduced calorie diet.
3.2.2. Specific Aim 3: To determine the effect of a novel, alternate day intermittent calorie restriction intervention on resting metabolic rate of college students with obesity as compared to a standard reduced calorie diet.
3.2.2. Specific Aim 4: To explore the relationships of stress, sleep physical activity and weight history/demographic variables in relation to primary outcomes of interest.
- Conditions
- Obesity
- Being tested
- Alternate Day Intermittent Energy Restriction, Reduced Calorie Diet
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alternate Day Intermittent Energy RestrictionOther
It is a dietary intervention designed to alternate between full energy consumption on one day and 40% of daily energy requirement on the following day.
Reduced Calorie DietOther
It is a dietary intervention designed to reduce daily calorie intake by 500-1000 kcal below an individual's daily calorie needs.
| Study group | Role | What they receive |
|---|---|---|
| Alternate Day Intermittent Energy Restriction | Experimental | Participants assigned to this diet will be asked to alternate between full calorie (no restriction) eating days with eating 40% of their daily caloric requirement on the other day. For example, if their requirement is 2000 calories they would eat 800 calories one day and as much as you want on the other day and repeat every two days. There will be occasional exceptions allowed with maximum of two 40% days in a row (followed by two full days) based on personal schedule with prior approval. They will follow this for 4 weeks. Receives: Other: Alternate Day Intermittent Energy Restriction |
| Reduced Calorie Diet | Active comparator | Participants assigned to this diet will be asked to restrict calorie intake by 500-1000 calories below their daily energy requirement every day. They will follow this for 4 weeks. Receives: Other: Reduced Calorie Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
Change in body weight in pounds.
Measured: 4 weeks
Fat Mass
Change in fat mass in pounds as measured by body composition assessment.
Measured: 4 weeks
Resting Metabolic Rate
Change in resting metabolic rate as measured by indirect calorimetry.
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start13 Jan 2022
- Primary completion5 Nov 2022
- Study completion5 Nov 2022
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.
- 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
- Model description
- 30 participants will be randomized into 1 of 2 groups 1) n=15 the experimental group that will receive the alternate day intermittent energy restriction intervention and 2 n=15 will be active control group that will follow a standard reduced calorie diet.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Binks, Texas Tech University
- Investigators
- Martin Binks, Ph.D., Principal investigator, Texas Tech University- Department of Nutritional Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213520
- Sponsor's protocol ID
- IRB2021-1092
- Acronym
- AltER2022
- Status last verified
- Nov 2022
- First submitted
- 18 Jan 2022
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Novel Alternate Day Intermittent Energy Restriction Intervention vs. Standard Reduced Calorie Diet on Body Weight, Body Composition, and Resting Metabolic Rate in College Students With Obesity
- ClinicalTrials.gov ID
- NCT05213520
- Acronym / sponsor ID
- AltER2022 / IRB2021-1092
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Study start
- 13 Jan 2022 (actual)
- Primary completion
- 5 Nov 2022 (actual)
- Study completion
- 5 Nov 2022 (actual)
- First posted
- 28 Jan 2022 (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.
This pilot study is an active control randomized controlled trial with a sample size of 30 that will consist of 2 groups, to evaluate the effects of a one-month alternate day intermittent energy restriction (AltER) intervention on body weight, body composition, resting metabolic rate in college students with obesity as compared to a standard reduced calorie diet (RCD). Among the 30 participants, 15 will be randomized into the experimental group that will receive the AltER intervention while the other 15 will be a part of the active control group that will follow a RCD. The study will be conducted at the Texas Tech University Nutrition and Metabolic Health Initiative.
Detailed description
This pilot study proposes to investigate the scope and benefits of a novel, hybrid alternate day fasting protocol tailored to the college student lifestyle. This protocol - Alternate Day Intermittent Energy Restriction (AltER) is novel because it proposes to modify the standard ADF regime by increasing energy intake to 40% of calorie needs on fasting days. While this may not be as restrictive as other protocols, it still can help create a significant energy deficit. Additionally, it will provide flexibility by allowing for two consecutive fast days if the individual chooses to. While most dietary interventions can achieve significant weight loss in this short duration we expect that this approach tailored to college lifestyle will be superior to typical dietary restriction.
Subjects will be asked to attend two approximately 90-minute assessment visits (4 weeks apart) at the NMHI facility They will have their height weight and blood pressure measured, fill out questionnaires (attached), and have body composition (BodPod) and resting metabolic rate (Metabolic Cart) measured.
At completion of visit one they are randomly assigned to one of two Diet protocols designed to reduce calories and help them to safely lose weight They will also be asked to respond to a brief (3 questions) email survey weekly.
The AltER diet alternate between full calorie (no restriction) eating days with eating 40% of your daily caloric requirement on the other day. There will be occasional exceptions allowed with maximum of two 40% days in a row (followed by two full days) based on personal schedule with prior PI approval. The RCD will require a reduction of 500-1000 calories below daily energy requirement. The intervention or control diet will be followed for a duration of 4 weeks at the end of which the participants will come in for visit 2 which will follow a similar format like visit 1.
General Aim
To determine the effect of a novel, alternate day intermittent calorie restriction intervention on body weight, fat mass and resting metabolic rate of college students with obesity as compared to a standard reduced calorie diet 3.2.1. Specific Aim 1: To determine the effect of a novel, alternate day intermittent calorie restriction intervention on body weight of college students with obesity as compared to a standard reduced calorie diet.
3.2.1. Specific Aim 2: To determine the effect of a novel, alternate day intermittent calorie restriction intervention on fat mass of college students with obesity as compared to a standard reduced calorie diet.
3.2.2. Specific Aim 3: To determine the effect of a novel, alternate day intermittent calorie restriction intervention on resting metabolic rate of college students with obesity as compared to a standard reduced calorie diet.
3.2.2. Specific Aim 4: To explore the relationships of stress, sleep physical activity and weight history/demographic variables in relation to primary outcomes of interest.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 30 participants will be randomized into 1 of 2 groups 1) n=15 the experimental group that will receive the alternate day intermittent energy restriction intervention and 2 n=15 will be active control group that will follow a standard reduced calorie diet.
| Arm | Type | Receives |
|---|---|---|
| Alternate Day Intermittent Energy Restriction | Experimental | Other: Alternate Day Intermittent Energy RestrictionParticipants assigned to this diet will be asked to alternate between full calorie (no restriction) eating days with eating 40% of their daily caloric requirement on the other day. For example, if their requirement is 2000 calories they would eat 800 calories one day and as much as you want on the other day and repeat every two days. There will be occasional exceptions allowed with maximum of two 40% days in a row (followed by two full days) based on personal schedule with prior approval. They will follow this for 4 weeks. |
| Reduced Calorie Diet | Active comparator | Other: Reduced Calorie DietParticipants assigned to this diet will be asked to restrict calorie intake by 500-1000 calories below their daily energy requirement every day. They will follow this for 4 weeks. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age: 18 -25 years
- Enrolled as full-time college students
- Have a BMI ≥ 30
- Willing and able to give informed consent
- Willing to follow either dietary intervention assigned to them upon randomization.
Key exclusion criteria (9 listed)
- Participants who are currently diagnosed with diabetes mellitus, cardiovascular disease, liver or kidney disease, cancer
- Current severe psychiatric illnesses (e.g. psychosis, schizophrenia, bipolar disorders, depression
- Current suicidal ideation, and recent or past suicide attempts
- History of psychiatric hospitalization (past year).
- History of diagnosed eating disorders such as bulimia nervosa, anorexia nervosa and severe binge eating disorder.
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 |
|---|---|---|
| Alternate Day Intermittent Energy RestrictionIt is a dietary intervention designed to alternate between full energy consumption on one day and 40% of daily energy requirement on the following day. | Other | Alternate Day Intermittent Energy Restriction |
| Reduced Calorie DietIt is a dietary intervention designed to reduce daily calorie intake by 500-1000 kcal below an individual's daily calorie needs. | Other | Reduced Calorie Diet |
Primary outcome
Body Weight
Time frame: 4 weeks
Change in body weight in pounds.
Fat Mass
Time frame: 4 weeks
Change in fat mass in pounds as measured by body composition assessment.
Resting Metabolic Rate
Time frame: 4 week
Change in resting metabolic rate as measured by indirect calorimetry.
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 6 May 2023.
- Individual participant dataSharing planned: No
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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.
Martin Binks, Ph.D. principal investigator
Texas Tech University- Department of Nutritional Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alternate Day Intermittent Energy Restriction and Reduced Calorie Diet in people with Obesity, run by Texas Tech University at 2 sites 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 6 inclusion and 9 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 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Body Weight (time frame: 4 weeks). The study lists 3 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 6 May 2023.