Low-calorie Diet for Impaired Fasting Glucose

Overseen By Sathish Thirunavukkarasu, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Must not be taking: Weight-loss drugs, Steroids, Antipsychotics

Disqualifiers: Diabetes, Cardiovascular disease, Cancers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 8 weeks

34 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop taking weight-loss medications or drugs known to affect blood sugar levels, like steroids and antipsychotics.

What data supports the effectiveness of the low-calorie diet treatment for impaired fasting glucose?

Research shows that a low-calorie diet can significantly lower blood sugar levels and improve metabolic health in people with type 2 diabetes. For example, one study found that a very low-calorie diet helped reduce fasting blood glucose and improve insulin sensitivity in obese patients. ^{1 2 3 4 5}

Is a low-calorie diet safe for humans?

Research shows that very low-calorie diets (VLCDs) have been studied for safety in people with obesity and type 2 diabetes. These diets are generally safe, but they should be followed under medical supervision to monitor any potential side effects. ^{6 7 8 9 10}

How does a low-calorie diet differ from other treatments for impaired fasting glucose?

A low-calorie diet is unique because it focuses on reducing energy intake to lower blood sugar levels, rather than using medication. This approach can help restore normal glucose metabolism, especially in people with recently diagnosed Type 2 diabetes, by promoting weight loss and improving insulin sensitivity. ^{3 4 7 11 12}

Research Team

Sathish Thirunavukkarasu, PhD

Principal Investigator

Emory University

Eligibility Criteria

This trial is for individuals aged 35 to 65 who are overweight or obese, have prediabetes or a high risk of diabetes according to the ADA tool, and are physically inactive. It's not suitable for those who already follow a specific diet or exercise routine.

Inclusion Criteria

I do less than 150 minutes of moderate or 75 minutes of vigorous exercise weekly.

I am between 35 and 65 years old.

I am overweight or obese according to my BMI.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Baseline

1 visit (in-person)

Treatment

Participants follow an 8-week low-calorie dietary regimen or maintain routine dietary habits

8 weeks

Regular monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Low-calorie Diet

Trial Overview The study is testing whether a low-calorie diet can improve fasting blood sugar levels in people with impaired fasting glucose. Participants will either continue their usual eating and activity habits or switch to the low-calorie diet.

Participant Groups

Group I: Low-calorie diet Experimental Treatment 1 Intervention

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.

Group II: Routine dietary and physical activity habits Active Control 1 Intervention

Control participants are asked to maintain their routine dietary and physical activity habits.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Findings from Research

In a study of 27 obese patients with type 2 diabetes, adding exercise to a very low-calorie diet (VLCD) resulted in greater fat loss and increased skeletal muscle mitochondrial DNA content compared to the VLCD alone.

While both groups showed similar improvements in insulin-stimulated glucose disposal, only the exercise group experienced significant enhancements in maximum aerobic capacity, indicating that exercise provides additional benefits beyond weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of adding exercise to a 16-week very low-calorie diet in obese, insulin-dependent type 2 diabetes mellitus patients. Snel, M., Gastaldelli, A., Ouwens, DM., et al.[2012]

Intermittent fasting (IF) and continuous energy-restricted diets (CERD) showed similar effects on glycemic control in patients with type 2 diabetes and metabolic syndrome, based on a meta-analysis of four studies with 355 participants.

However, IF resulted in greater weight loss compared to CERD, indicating it may be a beneficial dietary approach for overweight or obese patients with these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent fasting versus continuous energy-restricted diet for patients with type 2 diabetes mellitus and metabolic syndrome for glycemic control: A systematic review and meta-analysis of randomized controlled trials. Wang, X., Li, Q., Liu, Y., et al.[2021]

A very-low-calorie diet (VLCD) of 600 kcal/day was effective in inducing short-term remission of type 2 diabetes in 79% of the 19 Thai patients studied, with significant improvements in glycemic control and beta cell function observed within the first 2 weeks.

After 12 months, about 30% of participants maintained diabetes remission without medication, indicating that while VLCD can provide rapid benefits, long-term maintenance of glycemic control may require additional strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate and long-term effects of a very-low-calorie diet on diabetes remission and glycemic control in obese Thai patients with type 2 diabetes mellitus. Umphonsathien, M., Prutanopajai, P., Aiam-O-Ran, J., et al.[2023]

In a study of 44 patients with obesity, a Very Low Calorie Diet (VLCD) resulted in an average weight loss of 7 kg and a weight loss rate of 1.2 kg per week, indicating its effectiveness for weight management.

While 33% of participants reported mild side effects, such as constipation and dizziness, the majority (84%) adhered to the VLCD, suggesting that with proper support, adherence can be maintained.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness and safety of Very Low Calory Diets in obese patients]. Sáez Belló, M., Segarra Villalba, C., Gras Colomer, E., et al.[2018]

In a study of 325 participants who underwent a very low calorie diet (VLCD) program 15 years ago, long-term weight loss maintenance was rare, with only 5.9% managing to keep off more than 10% of their initial body weight.

The study found that while some participants experienced remission of type 2 diabetes shortly after the VLCD, lasting remission was uncommon, and 21.4% developed new glucose intolerance, indicating that the VLCD may not effectively prevent diabetes in the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Body weight, diabetes incidence vascular events and survival 15 years after very low calorie diet in community medical clinics in the UK. Paisey, R., Daniels, C., Howitt, W., et al.[2022]

References

1. Sweden pubmed.ncbi.nlm.nih.gov

Improved metabolic control after supplemented fasting in overweight type II diabetic patients. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Effects of adding exercise to a 16-week very low-calorie diet in obese, insulin-dependent type 2 diabetes mellitus patients. [2012]

3. United States pubmed.ncbi.nlm.nih.gov

UK Prospective Diabetes Study 7: response of fasting plasma glucose to diet therapy in newly presenting type II diabetic patients, UKPDS Group. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Factors predicting the blood glucose lowering effect of a 30-day very low calorie diet in obese Type 2 diabetic patients. [2006]

5. Sweden pubmed.ncbi.nlm.nih.gov

Diet therapy for poorly controlled type 2 (non-insulin-dependent) diabetes mellitus. [2019]

6. Ireland pubmed.ncbi.nlm.nih.gov

Intermittent fasting versus continuous energy-restricted diet for patients with type 2 diabetes mellitus and metabolic syndrome for glycemic control: A systematic review and meta-analysis of randomized controlled trials. [2021]

7. England pubmed.ncbi.nlm.nih.gov

The effect of a very low calorie diet on insulin sensitivity, beta cell function, insulin clearance, incretin hormone secretion, androgen levels and body composition in obese young women. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Immediate and long-term effects of a very-low-calorie diet on diabetes remission and glycemic control in obese Thai patients with type 2 diabetes mellitus. [2023]

9. Spain pubmed.ncbi.nlm.nih.gov

[Effectiveness and safety of Very Low Calory Diets in obese patients]. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Body weight, diabetes incidence vascular events and survival 15 years after very low calorie diet in community medical clinics in the UK. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Inducing remission of Type 2 diabetes in the Caribbean: findings from a mixed methods feasibility study of a low-calorie liquid diet-based intervention in Barbados. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

The effect of fasting and energy restricting diets on markers of glucose and insulin controls: a systematic review and meta-analysis of randomized controlled trials. [2022]