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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will systematically quantify the effects of protein pacing and intermittent fasting (P-IF) on total and regional (abdominal) body composition (lean mass and fat mass), blood glucose and lipids, and anti-aging biomarkers, hunger ratings, and the gut microbiome in 40 overweight/obese adult men (n=20) and women (n=20) following a 8-week weight loss intervention. Participants will be enrolled in the study as a single cohort and participate in a 8-week weight loss (WL) trial consisting of a single dietary intervention phase. The purpose of the additional 12 month follow up case study (in addition to the initial 12-month case study period) is to scientifically document a significant weight loss and improved body composition following combined protein pacing intermittent fasting nutrition and a safe, effective exercise program in a study participant who achieved successful weight loss maintenance during the previous 12 month follow up study period.

Research Team

Paul J Arciero, PhD

Principal Investigator

Skidmore College

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+