Isolated Impaired Fasting GlucoseNCT06451055
Low-calorie Diet in Isolated Impaired Fasting Glucose
A study testing Low-calorie diet and Routine dietary and physical activity habits in people with Isolated Impaired Fasting Glucose, run by Emory University at 1 site in United States.
Trial summary
This study aims to evaluate the preliminary efficacy of a low-calorie diet (LCD) intervention in addressing the underlying pathophysiological abnormalities and improving fasting hyperglycemia among individuals with isolated impaired fasting glucose (i-IFG). Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Isolated Impaired Fasting Glucose
- What is being tested?
- Low-calorie diet and Routine dietary and physical activity habits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to 30 Dec 2026
- 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 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 35 to 65 years
- Overweight (body mass index (BMI) ≥25 to <29 kg/m² or ≥23 to <29 kg/m² if Asian descent) or Obese (BMI ≥30 kg/m²)
- Physically inactive (<150 minutes per week of moderate-intensity physical activity or <75 minutes per week of vigorous-intensity physical activity)
- Prediabetes diagnosis or score ≥5 on the American Diabetes Association (ADA) risk tool
Who cannot join
- Diagnosed with type 1 or type 2 diabetes
- Cardiovascular disease (myocardial infarction, stroke, angina, heart failure, or other cardiac conditions)
- Chronic kidney disease
- Chronic liver disease (e.g., cirrhosis)
- Cancers
- Acute inflammatory bowel disease, irritable bowel syndrome, celiac disease, chronic pancreatitis, or other disorders potentially causing malabsorption
Show all 17Show fewer
- Food allergies
- Participation in weight loss programs in the past six months
- Currently following a specific diet (e.g., ketogenic diet, Mediterranean diet)
- Participation in any exercise programs in the past six months
- Currently taking weight-loss medications or drugs known to affect glycemia (steroids and antipsychotics)
- Previous bariatric surgery or plan to have bariatric surgery during the study period
- Planning to relocate during the study period
- Intending to fast during the study period for religious or other reasons
- Pregnancy or planning to become pregnant during the study period
- Breastfeeding
- Non-English speaker
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgia Clinical & Translational Science Alliance (CTSA) Clinical Research Centers (GCRCs)
Atlanta, Georgia, 30322
About this study
Official title: Effect of Dietary Energy Restriction on Reversing Isolated Impaired Fasting Glucose: A Proof of Concept Study
This study aims to evaluate the preliminary efficacy of a low-calorie diet (LCD) intervention in addressing the underlying pathophysiological abnormalities and improving fasting hyperglycemia among individuals with isolated impaired fasting glucose (i-IFG). Additionally, it seeks to assess the feasibility and acceptability of the LCD intervention.
Read the detailed description
This proof-of-concept randomized controlled trial (RCT) will enroll 34 individuals aged 35-65 years with overweight or obesity and isolated impaired fasting glucose. Intervention participants will adhere to an 8-week low-calorie dietary (LCD) regimen (~1,320 kcal/day) comprising specific macronutrient proportions (55% carbohydrate, 13% fat, 25% protein, and 2% fiber). Control participants will maintain their habitual dietary habits and physical activity levels. Primary outcomes at 8 weeks include between-group changes in weight, fasting plasma glucose, indices of ß-cell function and hepatic insulin resistance, and alanine aminotransferase levels. Secondary outcomes are feasibility metrics (response rate, screening yield, enrollment rate, intervention compliance, cost, staff time, and retention rate) and intervention acceptability. Qualitative research will explore facilitators, barriers, acceptability, satisfaction, and participant experiences with the LCD intervention.
- Conditions
- Isolated Impaired Fasting Glucose
- Being tested
- Low-calorie diet, Routine dietary and physical activity habits
- Keywords
- Low-calorie diet, Prediabetes, Overweight, Obesity, Fasting hyperglycemia
- Medical subject headings
- Prediabetic State, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-calorie dietBehavioural
Also called Dietary energy restriction
The low-calorie diet consists of approximately 1,300 kcal/day (37% carbohydrates, 25% protein, 39% fat, and 7 g of fiber per meal) over an eight-week period. Participants receive weekly pre-prepared meals from Trifecta Nutrition (Trifecta Inc. California, USA) with options for breakfast, lunch, and dinner, meticulously crafted by certified dieticians and expert chefs. Participants are encouraged to consume 1-2 liters of water daily and maintain their habitual physical activity levels.
Routine dietary and physical activity habitsBehavioural
Participants are asked to maintain their habitual dietary and physical activity habits for the 8-week study period.
| Study group | Role | What they receive |
|---|---|---|
| Low-calorie diet | Experimental | Participants following a low-calorie diet (LCD) consisting of approximately 1,300 kcal/day (37% carbohydrates, 25% protein, 39% fat, and 7 g of fiber per meal) over an eight-week period. Receives: Behavioral: Low-calorie diet |
| Routine dietary and physical activity habits | Active comparator | Control participants are asked to maintain their routine dietary and physical activity habits. Receives: Behavioral: Routine dietary and physical activity habits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Response rate is defined as the proportion of individuals responding to the invitation sent via the Epic database.
Measured: Baseline
Screening yield
Screening yield: Proportion of screened individuals meeting eligibility criteria.
Measured: Baseline
Enrollment rate
Enrollment rate: Proportion of eligible individuals who enroll in the study.
Measured: Baseline
Resource utilization
Resource utilization: Assessment of expenditures and staff time.
Measured: Throughout the study period, an average of 10 weeks
Retention rate
Retention rate: Proportion of enrolled participants who complete the study.
Measured: 4 and 8 weeks
Intervention acceptability
Intervention acceptability will be assessed using the Theoretical Framework of Acceptability questionnaire. Scores range from 7 to 35. Higher scores indicate better acceptability among participants.
Measured: 4 and 8 weeks
Feasibility of intervention
Will be assessed using the Feasibility of Intervention Measure questionnaire. Scores range from 4 to 20. Higher scores indicate better feasibility among participants.
Measured: 4 and 8 weeks
Intervention appropriateness
Will be assessed with the Intervention Appropriateness Measure questionnaire. Scores range from 4 to 20. Higher scores indicate better appropriateness among participants.
Measured: 4 and 8 weeks
Facilitators, barriers, acceptability, satisfaction, and participant experiences with the the intervention
Qualitative in-depth interviews
Measured: 4 and 8 weeks
Secondary outcomes (7)
Weight in kg
Weight will be measured using a digital weighing scale with an accuracy to the nearest 0.1 kg
Measured: 4 and 8 weeks
Fasting plasma glucose in mg/dl
Will be analyzed by enzymatic assays
Measured: 4 and 8 weeks
Indices of ß-cell function
Will be assessed using the insulinogenic index (IGI)
Measured: 4 and 8 weeks
ß-cell function assessed by Oral Disposition Index (DI(O))
Will be assessed using the Oral Disposition Index (DI(O))
Measured: 4 and 8 weeks
ß-cell function assessed by Homeostatic Model Assessment of ß-cell Function (HOMA-B)
Will be assessed using the Homeostatic Model Assessment of ß-cell Function (HOMA-B)
Measured: 4 and 8 weeks
Indices of hepatic insulin resistance
Will be assessed using the Hepatic Insulin Resistance Index (HIRI)
Measured: 4 and 8 weeks
Alanine aminotransferase (liver enzyme) in U/L
Will be analyzed with colorimetric assays
Measured: 4 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start1 Jun 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Why it stopped: Due to operational issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Isolated Impaired Fasting GlucoseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Beth Weber, Emory University
- Investigators
- Sathish Thirunavukkarasu, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451055
- Sponsor's protocol ID
- STUDY00007848
- Other IDs
- 2025P012671
- Status last verified
- Jun 2026
- First submitted
- 31 May 2024
- Last updated
- 17 Jun 2026
- 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 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dietary Energy Restriction on Reversing Isolated Impaired Fasting Glucose: A Proof of Concept Study
- ClinicalTrials.gov ID
- NCT06451055
- Acronym / sponsor ID
- STUDY00007848
- Conditions
- Isolated Impaired Fasting Glucose
- Keywords
- Low-calorie diet, Prediabetes, Overweight, Obesity, Fasting hyperglycemia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to operational issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 10 Jun 2024 (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 study aims to evaluate the preliminary efficacy of a low-calorie diet (LCD) intervention in addressing the underlying pathophysiological abnormalities and improving fasting hyperglycemia among individuals with isolated impaired fasting glucose (i-IFG). Additionally, it seeks to assess the feasibility and acceptability of the LCD intervention.
Detailed description
This proof-of-concept randomized controlled trial (RCT) will enroll 34 individuals aged 35-65 years with overweight or obesity and isolated impaired fasting glucose. Intervention participants will adhere to an 8-week low-calorie dietary (LCD) regimen (~1,320 kcal/day) comprising specific macronutrient proportions (55% carbohydrate, 13% fat, 25% protein, and 2% fiber). Control participants will maintain their habitual dietary habits and physical activity levels. Primary outcomes at 8 weeks include between-group changes in weight, fasting plasma glucose, indices of ß-cell function and hepatic insulin resistance, and alanine aminotransferase levels. Secondary outcomes are feasibility metrics (response rate, screening yield, enrollment rate, intervention compliance, cost, staff time, and retention rate) and intervention acceptability. Qualitative research will explore facilitators, barriers, acceptability, satisfaction, and participant experiences with the LCD intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-calorie diet | Experimental | Behavioral: Low-calorie dietParticipants following a low-calorie diet (LCD) consisting of approximately 1,300 kcal/day (37% carbohydrates, 25% protein, 39% fat, and 7 g of fiber per meal) over an eight-week period. |
| Routine dietary and physical activity habits | Active comparator | Behavioral: Routine dietary and physical activity habitsControl participants are asked to maintain their routine dietary and physical activity habits. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 35 to 65 years
- Overweight (body mass index (BMI) ≥25 to <29 kg/m² or ≥23 to <29 kg/m² if Asian descent) or Obese (BMI ≥30 kg/m²)
- Physically inactive (<150 minutes per week of moderate-intensity physical activity or <75 minutes per week of vigorous-intensity physical activity)
- Prediabetes diagnosis or score ≥5 on the American Diabetes Association (ADA) risk tool
Key exclusion criteria (17 listed)
- Diagnosed with type 1 or type 2 diabetes
- Cardiovascular disease (myocardial infarction, stroke, angina, heart failure, or other cardiac conditions)
- Chronic kidney disease
- Chronic liver disease (e.g., cirrhosis)
- Cancers
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 |
|---|---|---|
| Low-calorie dietAlso: Dietary energy restrictionThe low-calorie diet consists of approximately 1,300 kcal/day (37% carbohydrates, 25% protein, 39% fat, and 7 g of fiber per meal) over an eight-week period. Participants receive weekly pre-prepared meals from Trifecta Nutrition (Trifecta Inc. California, USA) with options for breakfast, lunch, and dinner, meticulously crafted by certified dieticians and expert chefs. Participants are encouraged to consume 1-2 liters of water daily and maintain their habitual physical activity levels. | Behavioural | Low-calorie diet |
| Routine dietary and physical activity habitsParticipants are asked to maintain their habitual dietary and physical activity habits for the 8-week study period. | Behavioural | Routine dietary and physical activity habits |
Primary outcome
Response rate
Time frame: Baseline
Response rate is defined as the proportion of individuals responding to the invitation sent via the Epic database.
Screening yield
Time frame: Baseline
Screening yield: Proportion of screened individuals meeting eligibility criteria.
Enrollment rate
Time frame: Baseline
Enrollment rate: Proportion of eligible individuals who enroll in the study.
Resource utilization
Time frame: Throughout the study period, an average of 10 weeks
Resource utilization: Assessment of expenditures and staff time.
Retention rate
Time frame: 4 and 8 weeks
Retention rate: Proportion of enrolled participants who complete the study.
Intervention acceptability
Time frame: 4 and 8 weeks
Intervention acceptability will be assessed using the Theoretical Framework of Acceptability questionnaire. Scores range from 7 to 35. Higher scores indicate better acceptability among participants.
Feasibility of intervention
Time frame: 4 and 8 weeks
Will be assessed using the Feasibility of Intervention Measure questionnaire. Scores range from 4 to 20. Higher scores indicate better feasibility among participants.
Intervention appropriateness
Time frame: 4 and 8 weeks
Will be assessed with the Intervention Appropriateness Measure questionnaire. Scores range from 4 to 20. Higher scores indicate better appropriateness among participants.
Facilitators, barriers, acceptability, satisfaction, and participant experiences with the the intervention
Time frame: 4 and 8 weeks
Qualitative in-depth interviews
7 secondary outcomes
Weight in kg
Time frame: 4 and 8 weeks
Fasting plasma glucose in mg/dl
Time frame: 4 and 8 weeks
Indices of ß-cell function
Time frame: 4 and 8 weeks
ß-cell function assessed by Oral Disposition Index (DI(O))
Time frame: 4 and 8 weeks
ß-cell function assessed by Homeostatic Model Assessment of ß-cell Function (HOMA-B)
Time frame: 4 and 8 weeks
Indices of hepatic insulin resistance
Time frame: 4 and 8 weeks
Alanine aminotransferase (liver enzyme) in U/L
Time frame: 4 and 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No
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.
Sathish Thirunavukkarasu, PhD principal investigator
Emory University
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 Routine dietary and physical activity habits in people with Isolated Impaired Fasting Glucose, run by Emory University 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 4 inclusion and 17 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: withdrawn, as of the sponsor's last update on 17 Jun 2026. 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 was withdrawn before enrolling participants, so there are no results.
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?
Response rate (time frame: Baseline). The study lists 9 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 17 Jun 2026.