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Low Sugar Protein Pacing + Intermittent Fasting for Weight Loss

N/A

Waitlist Available

Led By Paul J Arciero, PhD

Research Sponsored by Skidmore College

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0 weeks, 8 weeks, 1 year and 2 year of the case study

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the effects of protein pacing and intermittent fasting on weight loss, body composition, blood sugar, lipids, and other markers in 40 obese men and women.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort from dietary changes such as hunger during fasting periods; digestive issues due to new foods introduced in the diet; possible nutrient deficiencies if the diet lacks variety; and fatigue due to calorie restriction.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 weeks, 8 weeks, 1 year and 2 year of the case study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0 weeks, 8 weeks, 1 year and 2 year of the case study

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 weeks, 8 weeks, 1 year and 2 year of the case study 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 blood lipid levels

Change in blood pressure

Change in energy intake

+6 more

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

Group I: Protein pacing and intermittent fastingExperimental Treatment1 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 HealthyExperimental Treatment1 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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

2013

N/A

~50

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