Low Sugar Protein Pacing + Intermittent Fasting for Weight Loss

Overseen By Karen M Arciero, DPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Skidmore College

Disqualifiers: Diabetes, Heart disease, Cancer, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to explore how a combination of protein pacing (eating protein regularly throughout the day) and intermittent fasting affects body composition, blood sugar, and other health markers in people who are overweight or obese. Participants will try different eating plans over eight weeks, including one that mixes protein-focused meals with fasting days (PP-IF) and another that follows heart-healthy dietary guidelines (HH). The trial seeks non-smoking adults who have been overweight for at least six months and are not very active.

As an unphased study, this trial offers a unique opportunity to contribute to understanding innovative dietary approaches for improving health.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both protein pacing and intermittent fasting (P-IF) are generally safe and well-tolerated for weight loss. Studies have found that P-IF aids in weight loss and improves body shape without major health risks. Participants in those studies did not report serious side effects, indicating these were rare or absent.

The Heart Healthy (HH) diet has also proven safe. It follows guidelines from health organizations like the National Cholesterol Education Program and focuses on lowering bad cholesterol, making it a safe choice for improving heart health.

Both dietary methods have strong safety records, offering promising options for those interested in joining clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they combine low sugar protein pacing with intermittent fasting (P-IF) and a heart-healthy (HH) diet to tackle weight loss in innovative ways. Unlike traditional calorie-restricted diets that often only focus on limiting food intake, the P-IF approach alternates between protein-rich meals and intermittent fasting days, potentially boosting metabolism and enhancing fat loss. Meanwhile, the HH treatment adheres to the National Cholesterol Education Program's guidelines, emphasizing balanced macronutrient intake and fiber, which may improve cardiovascular health alongside weight loss. By exploring these different dietary strategies, this trial aims to uncover more effective and sustainable weight loss methods that might offer additional health benefits.

What evidence suggests that this trial's treatments could be effective for weight loss?

This trial will compare the effects of two different dietary approaches for weight loss. One treatment arm will combine protein pacing with intermittent fasting (P-IF). Studies have shown that this approach can lead to significant weight loss, with participants losing about 9% of their body weight, surpassing those on regular calorie-restricted diets. Participants also experienced a greater reduction in total body fat and belly fat. Specifically, one study found that following this plan for a year resulted in major decreases in weight, waist size, and body fat percentage.

The other treatment arm will follow the Heart Healthy diet, based on guidelines from the National Cholesterol Education Program. This diet is also effective for weight loss, with participants losing at least 5% of their starting weight. U.S. News & World Report ranks this diet highly among weight loss diets. It focuses on low-fat and high-fiber foods, which can help people feel full while consuming fewer calories. ^{1 2 6 7 8}

Who Is on the Research Team?

Paul J Arciero, PhD

Principal Investigator

Skidmore College

Are You a Good Fit for This Trial?

This trial is for overweight or obese non-smoking men and women who have been weight stable for the past 6 months, with no cardiovascular or metabolic diseases. They should be sedentary or lightly active and not pregnant. People with diabetes, significant heart disease, eating disorders, certain allergies, cancer treatments, or fasting intolerances cannot join.

Inclusion Criteria

Weight stable (+/-2kg) for at least 6 months prior to beginning the study

Non-smoking, healthy, but overweight/obese men and women with no known cardiovascular or metabolic diseases as assessed by a medical history and a comprehensive medical examination by their physicians

You are considered overweight or obese based on your body mass index (BMI) or percentage of body fat.

Exclusion Criteria

You have chronic obstructive pulmonary disease (COPD).

Fasting intolerances/hypoglycemia

Pregnant or plan to become pregnant during 8-week study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Weight Loss Intervention

Participants follow a dietary intervention phase with protein pacing and intermittent fasting or a heart healthy diet

8 weeks

Weekly visits for monitoring and dietary adjustments

Follow-up Case Study

Participants are monitored for weight loss maintenance and health improvements over a long-term period

12 months

Monthly visits for health assessments

Extended Follow-up

Additional follow-up to document long-term weight loss and body composition improvements

12 months

Bi-monthly visits for continued monitoring

What Are the Treatments Tested in This Trial?

Interventions

• HH
• P-IF
• PP-IF

Trial Overview The study tests a diet called protein pacing combined with intermittent fasting (P-IF) over an 8-week period to see its effects on body composition, blood sugar levels, lipids (fats), anti-aging markers, hunger feelings and gut health. Participants will also follow up for an additional year to monitor long-term weight loss maintenance.

How Is the Trial Designed?

Group I: Protein pacing and intermittent fasting Experimental Treatment 1 Intervention

During the 8-week weight loss (WL) phase, participants assigned to the P-IF will consist of P days, whereby female participants will consume four and male participants will consume five meals/snacks total, two of which (breakfast and lunch) will include a protein powder meal replacement mixed with water (240-400 kcals per meal) along with an evening dinner meal (\~500 kcals), an afternoon snack (men only), and an evening snack (250 kcals). Subjects will be calorie restricted to \~1500 and \~1800 calories per day, women and men, respectively during P days. For each IF day, subjects will be provided a variety of supplements/snacks made by Isagenix International LLC. The P-IF group will be further divided into two subgroups for weeks 1-4. One subgroup will consist of five days of P and two days of IF, and the second subgroup will consist of six days of P and one day of IF. For weeks 5-8 both subgroups will follow 6 days of a P diet and 1 day IF.

Group II: Heart Healthy Experimental Treatment 1 Intervention

The HH group will observe the dietary guidelines in compliance with the National Cholesterol Education Program Therapeutic Lifestyle Changes (TLC) diet. This diet consists of consuming \<35% of kcal as fat; 50%-60% of kcal as carbohydrates; \<200 mg/dL of dietary cholesterol; and 20-30 g/day of fiber. The total calorie intake will be 1200 and 1500 calories per day, women and men, respectively during the weight loss phase (weeks 0-8).

Who Is Running the Clinical Trial?

Skidmore College

Lead Sponsor

Trials

20

Recruited

1,100+

Arizona State University

Collaborator

Trials

311

Recruited

109,000+

Isagenix International LLC

Industry Sponsor

Trials

6

Recruited

210+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10128075/

A Heart-Healthy Diet for Cardiovascular Disease Prevention Emerging diets like the ketogenic diet and intermittent fasting are effective weight loss diets with unknown heart protective benefits, and ...

2. ahajournals.org ahajournals.org/doi/10.1161/JAHA.122.026777

Journal of the American Heart Association US adults who have achieved clinically significant weight loss in the past 12 months reported higher overall diet quality, greater levels of ...

3. health.usnews.com health.usnews.com/best-diet/tlc-diet

TLC Diet: Reviews, Meal Plan, Food List & Tips (2025) - Health The TLC diet is one of U.S. News & World Report's Best Diets of 2025. Read more for TLC diet meal plans, food lists and tips.

4. nhlbi.nih.gov nhlbi.nih.gov/files/docs/public/heart/chol_tlc.pdf

Your Guide to Lowering Your Cholesterol With TLC - NHLBI Further, eating foods rich in fiber can help you feel full on fewer calories, which makes it a good food choice if you need to lose weight. 23. T reating High ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa0804748

Comparison of Weight-Loss Diets with Different ... At 2 years, 31 to 37% of the participants had lost at least 5% of their initial body weight, 14 to 15% of the participants in each diet group had lost at least ...

6. heart.org heart.org/en/healthy-living/healthy-eating/eat-smart/nutrition-basics/aha-diet-and-lifestyle-recommendations

The American Heart Association Diet and Lifestyle ... Read the Nutrition Facts and ingredient list on packaged food labels to choose those with less sodium, added sugars and saturated fat. Look for ...

7. who.int who.int/news-room/fact-sheets/detail/healthy-diet

Healthy diet A healthy diet helps to protect against malnutrition in all its forms, as well as noncommunicable diseases (NCDs), including diabetes, heart ...

8. mayoclinic.org mayoclinic.org/diseases-conditions/heart-disease/in-depth/heart-healthy-diet/art-20047702

Heart-healthy diet: 8 steps to prevent heart disease Certain foods can raise your risk of heart conditions. Learn eight ways to get started on a diet that's good for your heart.