ObesityNCT03528317
Alternate Day Fasting Combined With a High Protein Background Diet
A study testing Alternate day fasting in people with Obesity, run by University of Illinois Chicago at 1 site in United States.
Trial summary
The aims of this study are as follows: AIM 1: To examine the weight loss and weight maintenance efficacy of an alternate day fasting-high protein (ADF-HP) diet; AIM 2: To examine the effects of an ADF-HP diet on metabolic disease risk factors (plasma lipids, fasting glucose, fasting insulin, insulin resistance). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Alternate day fasting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 1 Mar 2019
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18 to 65 years old
- BMI between 30.0 and 49.9 kg/m2
- Previously sedentary or lightly active
Who cannot join
- Diabetic
- History of binge eating disorder
- Taking weight loss-inducing medications
- Not weight stable for 3 months prior to the study (weight gain or loss > 4 kg)
- Perimenopausal or have an irregular menstrual cycle (menses that does not appear every 27-32 days)
- Pregnant or trying to become pregnant
- Night shift worker
- Smokers
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois, Chicago
Chicago, Illinois, 60622
About this study
Official title: Alternate Day Fasting Combined With a High Protein Background Diet for Weight Loss and Weight Maintenance in Adults With Obesity
The aims of this study are as follows: AIM 1: To examine the weight loss and weight maintenance efficacy of an alternate day fasting-high protein (ADF-HP) diet; AIM 2: To examine the effects of an ADF-HP diet on metabolic disease risk factors (plasma lipids, fasting glucose, fasting insulin, insulin resistance).
Read the detailed description
Background: Accumulating evidence suggests that alternate day fasting (ADF) is an effective diet strategy to help individuals with obesity lose weight and lower metabolic disease risk. ADF regimens include a "feast day" where food is consumed ad-libitum over 24 h, alternated with a "fast day" where intake is limited to ~600 kcal over 24 h. What has yet to be elucidated is whether consuming a high protein diet (as meal replacements) during ADF is effective for weight loss, weight maintenance, and metabolic disease risk reduction in individuals with obesity.
Objective: The aims of this study are as follows: AIM 1: To examine the weight loss and weight maintenance efficacy of an alternate day fasting-high protein (ADF-HP) diet; AIM 2: To examine the effects of an ADF-HP diet on metabolic disease risk factors (plasma lipids, fasting glucose, fasting insulin, insulin resistance).
Methods: A 24-week, single-center, longitudinal pilot study will be conducted to test the study objectives. The trial will be divided into 2 consecutive intervention periods: (1) 12-week weight loss period, and (2) 12-week weight maintenance period. Subjects with obesity will participate in an ADF-HP: alternate day fasting-high protein diet: 600 kcal "fast day" alternated with ad libitum "feast day", 35% kcal as protein. ADF-HP subjects will consume the Optifast HP Shake Mix (Nestle) on each day of the trial. Body weight, insulin, glucose, and insulin resistance, will be measured at baseline, week 12, and week 24.
Significance: These findings may show that alternate day fasting combined with high protein meal replacements may be implemented as an effective diet therapy to help individuals with obesity lose weight, maintain weight loss, and sustain reductions in metabolic disease risk.
- Conditions
- Obesity
- Being tested
- Alternate day fasting
- 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 fastingOther
Alternate day fasting with a high protein diet
| Study group | Role | What they receive |
|---|---|---|
| Alternate day fasting | Experimental | Alternate day fasting with a high protein diet Receives: Other: Alternate day fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Measured by digital scale
Measured: Change from baseline to week 24
Secondary outcomes (8)
Triglycerides
Measured by ELISA
Measured: Change from baseline to week 24
Glucose
Measured by glucometer
Measured: Change from baseline to week 24
Insulin
Measured ELISA
Measured: Change from baseline to week 24
Insulin resistance
Measured as HOMA-IR
Measured: Change from baseline to week 24
Sleep quality
Measured by Pittsburgh Sleep Quality Index (PSQI), total score of 0-21. A PSQI
Measured: Change from baseline to week 24
Insomnia severity
Measured by Insomnia Severity Index (ISI), total score of 0-28. The total score for the ISI is interpreted as follows: no clinically significant insomnia (0-7), sub-threshold insomnia (8-14), moderate severity insomnia (15-21), and severe insomnia (22-28).
Measured: Change from baseline to week 24
Sleep apnea
Measured by Berlin Questionnaire, measures the presence or absence of sleep apnea
Measured: Change from baseline to week 24
Appetite
Measured by Visual analog scale (VAS). Scored from 0-100. Higher score means higher appetite.
Measured: Change from baseline to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start1 Jun 2018
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Krista Varady, University of Illinois Chicago
- Investigators
- Krista Varady, Principal investigator, University of Illinois Chicago (UIC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03528317
- Sponsor's protocol ID
- 2017-1363
- Status last verified
- Jan 2021
- First submitted
- 24 Apr 2018
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akasheh RT, Fantuzzi G, Varady KA, Cheng TD, Kalam F. Reduced Serum PD-L1 and Markers of Inflammation in Response to Alternate Day Fasting With a Low-Carbohydrate Intervention: A Secondary Analysis of a Single-Arm Trial. Curr Dev Nutr. 2025 Feb 14;9(3):104566. doi: 10.1016/j.cdnut.2025.104566. eCollection 2025 Mar.
PubMed 40145019Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.
PubMed 33512717Kalam F, Gabel K, Cienfuegos S, Wiseman E, Ezpeleta M, Pavlou V, Varady KA. Changes in subjective measures of appetite during 6 months of alternate day fasting with a low carbohydrate diet. Clin Nutr ESPEN. 2021 Feb;41:417-422. doi: 10.1016/j.clnesp.2020.10.007. Epub 2020 Oct 29.
PubMed 33487299Lin S, Lima Oliveira M, Gabel K, Kalam F, Cienfuegos S, Ezpeleta M, Bhutani S, Varady KA. Does the weight loss efficacy of alternate day fasting differ according to sex and menopausal status? Nutr Metab Cardiovasc Dis. 2021 Feb 8;31(2):641-649. doi: 10.1016/j.numecd.2020.10.018. Epub 2020 Oct 31.
PubMed 33358713
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alternate Day Fasting Combined With a High Protein Background Diet for Weight Loss and Weight Maintenance in Adults With Obesity
- ClinicalTrials.gov ID
- NCT03528317
- Acronym / sponsor ID
- 2017-1363
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 17 May 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.
The aims of this study are as follows: AIM 1: To examine the weight loss and weight maintenance efficacy of an alternate day fasting-high protein (ADF-HP) diet; AIM 2: To examine the effects of an ADF-HP diet on metabolic disease risk factors (plasma lipids, fasting glucose, fasting insulin, insulin resistance).
Detailed description
Background: Accumulating evidence suggests that alternate day fasting (ADF) is an effective diet strategy to help individuals with obesity lose weight and lower metabolic disease risk. ADF regimens include a "feast day" where food is consumed ad-libitum over 24 h, alternated with a "fast day" where intake is limited to ~600 kcal over 24 h. What has yet to be elucidated is whether consuming a high protein diet (as meal replacements) during ADF is effective for weight loss, weight maintenance, and metabolic disease risk reduction in individuals with obesity.
Objective: The aims of this study are as follows: AIM 1: To examine the weight loss and weight maintenance efficacy of an alternate day fasting-high protein (ADF-HP) diet; AIM 2: To examine the effects of an ADF-HP diet on metabolic disease risk factors (plasma lipids, fasting glucose, fasting insulin, insulin resistance).
Methods: A 24-week, single-center, longitudinal pilot study will be conducted to test the study objectives. The trial will be divided into 2 consecutive intervention periods: (1) 12-week weight loss period, and (2) 12-week weight maintenance period. Subjects with obesity will participate in an ADF-HP: alternate day fasting-high protein diet: 600 kcal "fast day" alternated with ad libitum "feast day", 35% kcal as protein. ADF-HP subjects will consume the Optifast HP Shake Mix (Nestle) on each day of the trial. Body weight, insulin, glucose, and insulin resistance, will be measured at baseline, week 12, and week 24.
Significance: These findings may show that alternate day fasting combined with high protein meal replacements may be implemented as an effective diet therapy to help individuals with obesity lose weight, maintain weight loss, and sustain reductions in metabolic disease risk.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alternate day fasting | Experimental | Other: Alternate day fastingAlternate day fasting with a high protein diet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 to 65 years old
- BMI between 30.0 and 49.9 kg/m2
- Previously sedentary or lightly active
Key exclusion criteria (8 listed)
- Diabetic
- History of binge eating disorder
- Taking weight loss-inducing medications
- Not weight stable for 3 months prior to the study (weight gain or loss > 4 kg)
- Perimenopausal or have an irregular menstrual cycle (menses that does not appear every 27-32 days)
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 fastingAlternate day fasting with a high protein diet | Other | Alternate day fasting |
Primary outcome
Body weight
Time frame: Change from baseline to week 24
Measured by digital scale
8 secondary outcomes
Triglycerides
Time frame: Change from baseline to week 24
Glucose
Time frame: Change from baseline to week 24
Insulin
Time frame: Change from baseline to week 24
Insulin resistance
Time frame: Change from baseline to week 24
Sleep quality
Time frame: Change from baseline to week 24
Insomnia severity
Time frame: Change from baseline to week 24
Sleep apnea
Time frame: Change from baseline to week 24
Appetite
Time frame: Change from baseline to 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 8 Jan 2021.
- Derived from this study: PubMed 40145019Akasheh RT, Fantuzzi G, Varady KA, Cheng TD, Kalam F. Reduced Serum PD-L1 and Markers of Inflammation in Response to Alternate Day Fasting With a Low-Carbohydrate Intervention: A Secondary Analysis of a Single-Arm Trial. Curr Dev Nutr. 2025 Feb 14;9(3):104566. doi: 10.1016/j.cdnut.2025.104566. eCollection 2025 Mar.
- Derived from this study: PubMed 33512717Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.
- Derived from this study: PubMed 33487299Kalam F, Gabel K, Cienfuegos S, Wiseman E, Ezpeleta M, Pavlou V, Varady KA. Changes in subjective measures of appetite during 6 months of alternate day fasting with a low carbohydrate diet. Clin Nutr ESPEN. 2021 Feb;41:417-422. doi: 10.1016/j.clnesp.2020.10.007. Epub 2020 Oct 29.
- Derived from this study: PubMed 33358713Lin S, Lima Oliveira M, Gabel K, Kalam F, Cienfuegos S, Ezpeleta M, Bhutani S, Varady KA. Does the weight loss efficacy of alternate day fasting differ according to sex and menopausal status? Nutr Metab Cardiovasc Dis. 2021 Feb 8;31(2):641-649. doi: 10.1016/j.numecd.2020.10.018. Epub 2020 Oct 31.
- 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.
Krista Varady principal investigator
University of Illinois Chicago (UIC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alternate day fasting in people with Obesity, run by University of Illinois Chicago 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 8 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 8 Jan 2021. 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?
Body weight (time frame: Change from baseline to week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03528317, which also lists 4 linked publications.
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 8 Jan 2021.