What side effects are associated with this type of intervention?

Common treatments for obesity include lifestyle interventions such as intermittent fasting, dietary changes, and increased physical activity, as well as pharmacotherapy. Intermittent fasting generally has fewer side effects but may cause hunger, irritability, and reduced concentration initially. Pharmacotherapy options like orlistat can cause gastrointestinal issues such as intestinal borborygmi, oily stools, and flatulence. Other medications like metformin, used for weight management in diabetes, may cause gastrointestinal discomfort, including nausea and diarrhea. It's important to consult with a healthcare provider to tailor the treatment plan to individual needs and manage any potential side effects.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of obesity, including semaglutide and liraglutide, which are GLP-1 receptor agonists that help regulate appetite and improve metabolic health. These drugs have shown significant weight loss benefits in clinical trials, such as the STEP trials for semaglutide. While these medications do not directly mimic intermittent fasting, they help reduce caloric intake and improve metabolic parameters, aligning with the goals of intermittent fasting. Other drugs like metformin and topiramate have also been used off-label for weight management in specific populations, such as those with severe mental illness.

What other types of research exist?

Promising novel alternatives to intermittent fasting for obesity patients include: 1) GLP-1 agonists like liraglutide and extended-release exenatide, which help in weight loss and improve metabolic health. 2) Bariatric surgery, which has shown improvement in obesity-related conditions. 3) Weight-based dosing regimens for medications like ustekinumab to enhance efficacy in obese patients. 4) Lifestyle modifications including diet and exercise, which remain foundational and effective.

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Intermittent Fasting for Obesity (POWER-VET Trial)

N/A

Waitlist Available

Led By Alice S. Ryan, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

50-75 years of age

Postmenopausal status for women

Must not have

Active inflammatory, autoimmune, infectious, hepatic, gastrointestinal, malignant, and psychiatric disease

Impaired renal function (creatinine > 1.5 mg/dl)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, after 12 weeks of weight loss+exercise, at 36-week weight maintenance, and 48-week follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing intermittent fasting as a way to help overweight and obese Veterans keep weight off after losing it. Intermittent fasting involves eating only during certain times and not eating at other times. The study will also look at how muscle enzymes that burn fat might help with long-term weight management. Intermittent fasting is a popular weight management intervention that has been widely applied to the treatment of overweight and obesity in adults.

Who is the study for?

This trial is for veterans aged 50-75 with a BMI of 25-40, including postmenopausal women. It's not suitable for those who've had significant weight changes recently, are on blood thinners (for muscle biopsies), have impaired kidney function, serious liver disease, uncontrolled diabetes, or active major health conditions.

What is being tested?

The study is testing traditional weight maintenance methods against the addition of intermittent fasting to see if it helps prevent weight regain after loss. The goal is to find cost-effective strategies for managing obesity in adults.

What are the potential side effects?

While the trial itself doesn't involve medication that could cause side effects, intermittent fasting may lead to hunger pangs, fatigue, headaches or irritability initially as the body adjusts to new eating patterns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 50 and 75 years old.

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I am a woman who has gone through menopause.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have active inflammatory, autoimmune, infectious, hepatic, gastrointestinal, malignant, or psychiatric diseases.

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My kidney function is impaired with creatinine levels above 1.5 mg/dl.

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My diabetes is not under control, with HbA1c over 10% or I am using insulin.

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My liver tests are more than 2.5 times the normal limit.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, after 12 weeks of weight loss+exercise, at 36-week weight maintenance, and 48-week follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, after 12 weeks of weight loss+exercise, at 36-week weight maintenance, and 48-week follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, after 12 weeks of weight loss+exercise, at 36-week weight maintenance, and 48-week follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Body Weight

Secondary study objectives

Change in Gait Speed

Change in LPL

Change in body fat

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Weight Maintenance + Intermittent FastingExperimental Treatment1 Intervention

Heart Healthy nutrition, walking, resistance band exercise and intermittent fasting (2 small meals per day) one day per week for 24 weeks.

Group II: Weight MaintenanceActive Control1 Intervention

Heart Healthy nutrition, walking, resistance band exercise

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for obesity include lifestyle changes, pharmacologic therapy, and metabolic surgery. Lifestyle changes, such as intermittent fasting, regulate eating patterns to reduce caloric intake and improve metabolic health by enhancing insulin sensitivity and reducing insulin resistance. Pharmacologic therapies often work by decreasing appetite, increasing metabolic rate, or altering fat absorption. Metabolic surgeries, like gastric bypass, physically restrict food intake and alter gut hormone levels to promote satiety and reduce hunger. These treatments are crucial for obesity patients as they address the underlying metabolic disturbances, aid in significant weight loss, and improve comorbid conditions like type 2 diabetes, hypertension, and cardiovascular diseases.

Pharmacotherapy of obesity: emerging drugs and targets.