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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a low-calorie diet can improve high blood sugar levels in people with prediabetes. Participants will follow a specific diet plan for eight weeks to determine if it manages blood sugar more effectively than their usual eating and exercise habits. It is ideal for individuals diagnosed with prediabetes who are overweight or obese and not very active. As an unphased trial, this study provides a unique opportunity to explore new dietary methods for managing prediabetes.

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 prior data suggests that this low-calorie diet is safe for individuals with impaired fasting glucose?

Research shows that low-calorie diets are generally safe and easy for most people to follow, with only mild side effects typically experienced. One study found that these diets were tested in individuals with obesity and type 2 diabetes and were considered safe for them. This suggests that a low-calorie diet might also be safe for those with high blood sugar levels. Notably, studies indicate that serious side effects are uncommon. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the low-calorie diet (LCD) for impaired fasting glucose because it offers a non-pharmacological approach to managing blood sugar levels. Unlike medications that target glucose regulation directly, this diet involves consuming approximately 1,300 kcal per day with a balanced macronutrient distribution, potentially leading to weight loss and improved insulin sensitivity. This dietary intervention is appealing because it emphasizes lifestyle changes without the side effects associated with medication, and it may provide a sustainable way to manage glucose levels long-term.

What evidence suggests that a low-calorie diet might be an effective treatment for impaired fasting glucose?

Studies have shown that low-calorie diets can significantly lower fasting blood sugar levels in people with high blood sugar when they haven't eaten. For example, one study found that these diets reduced fasting blood sugar by 27.8 to 43.2 mg/dL. In this trial, participants in the low-calorie diet arm will follow a diet of approximately 1,300 calories a day with a specific nutrient mix, which may help improve blood sugar control. Standard lifestyle changes often prove ineffective for this condition, so a low-calorie diet might offer a better option. Additionally, many participants in these studies successfully lost weight, which also aids in managing blood sugar issues. ^{2 3 6 7 8}

Who Is on the Research Team?

Sathish Thirunavukkarasu, PhD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10907622/

Low-calorie diets for people with isolated impaired fasting ... As a result, fasting plasma glucose levels decreased significantly by 27.8 to 43.2 mg/dL. This suggests that low-calorie diets may also be ...

2. diabetes.org diabetes.org/newsroom/weight-loss-from-low-calories

Weight Loss from Low-Calorie Diet, Followed by Different ... Of the 2,223 originally enrolled, 2,202 successfully lost 8% of weight during the LCD, and in January 2019 when the study ended, 962 still ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06451055

Low-calorie Diet in Isolated Impaired Fasting Glucose Primary outcomes at 8 weeks include between-group changes in weight, fasting plasma glucose, indices of ß-cell function and hepatic insulin resistance, and ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38429400/

Low-calorie diets for people with isolated impaired fasting ... Standard lifestyle interventions prove ineffective in preventing type 2 diabetes among individuals with isolated impaired fasting glucose, ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04786418

Low-Calorie Diet in People With Prediabetes/Metabolic ... The investigators will examine how much the weight loss improves the metabolic abnormalities that precede type 2 diabetes (T2D), and in reversing the pre- ...

6. nature.com nature.com/articles/s43856-024-00466-2

Low-calorie diets for people with isolated impaired fasting ... These diets are generally well-tolerated and safe, with only mild side effects reported. Table 1 summarizes the key low-calorie diet studies ...

7. withpower.com withpower.com/trial/phase-prediabetic-state-6-2024-5cd71

Low-calorie Diet for Impaired Fasting Glucose 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 ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8668312/

Comparing the Efficacy and Safety of Low-Carbohydrate Diets ... To compare the efficacy of low-carbohydrate diets (LCDs) with low-fat diets (LFDs) in body weight and glycemic control for type 2 diabetes ...