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Weight LossNCT04327141

Low Sugar Protein Pacing, Intermittent Fasting Diet in Men and Women

A study testing P-IF and HH in people with Weight Loss and Gut Microbiome, run by Skidmore College at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 25 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Weight Loss, Gut Microbiome, Anti-Aging
What is being tested?
P-IF and HH
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
3 Sep 2020to 31 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
  • Sedentary or lightly active (<30 min, 2d/wk of structured physical activity) as assessed by a Physical Activity questionnaire
  • Overweight or obese (BMI>27.5 kg/m2; % body fat>30%)
  • Weight stable (+/-2kg) for at least 6 months prior to beginning the study

Who cannot join

  • Type II Diabetes
  • Emphysema
  • Significant heart disease (CABG, CHF, VFib, Hypercholesterolemia, Uncontrolled High Blood Pressure, etc.)
  • COPD
  • Cancer or undergoing treatment for cancer
  • Allergies to milk or milk products, sugar alcohols, fructose, or gluten
Show all 9Show fewer
  • Anorexia or Bulimia
  • Fasting intolerances/hypoglycemia
  • Pregnant or plan to become pregnant during 8-week study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Human Nutrition and Metabolism Laboratory

    Saratoga Springs, New York, 12866

Other trials in United States

About this study

Official title: Comparison of Protein Pacing, Intermittent Fast vs. Heart Healthy Diet on Body Weight and Composition, Cardiometabolic, Mood, and Gut Microbiome Health, in Overweight Men and Women During Weight Loss; 24 Months Follow-up Case Study of 100 Pound Weight Loss in a Male Study Participant

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.

Read the detailed description

Previous research has shown combined protein pacing and intermittent fasting (PP-IF; 1-2 days per week) combined with moderate (20-30%) caloric restriction (CR) favorably enhance weight loss, body composition, cardiometabolic disease risk, oxidative stress, and toxin levels compared to a heart healthy diet in obese individuals following both weight loss and weight loss maintenance (Arciero et al. 2016; He et al. 2017; Zuo et al. 2016). However, less is known about whether a low sugar intake with this dietary pattern induces other significant health improvements, such as enhanced brain health (mood state), as well as gut microbiome and anti-aging indices, compared to a heart healthy diet. The novelty of the current proposal is of particular relevance and importance given the heightened popularity of low sugar dietary patterns shown to enhance health status. Most notably, among these low sugar diets touting the health benefits, are the ketogenic, paleolithic and Mediterranean diets. In addition, there is a great deal of public health emphasis on reducing overall carbohydrate intake, especially simple sugars, to improve cardiometabolic, gut, and body composition health. The dangers of high simple sugar intake are numerous, including increased risk for cardiometabolic disease (high blood lipids, hyperglycemia, insulin resistance, systemic inflammation, oxidative stress, obesity, elevated visceral fat, etc.). Thus, improvements in body composition and reductions in disease risk provides compelling evidence to pursue this study with vigor so as to generate a viable and healthy weight and fat loss strategy over the long term. Another major factor to augment long-term (>1 year) weight loss success, is inclusion of a safe and realistic exercise program (4 days/week) consisting of walking, stretching, and simple body weight movements such as sit-ups and push-ups. To date, there are no documented case studies of a human participant achieving a one hundred pound plus weight loss using protein pacing and intermittent fasting combined with a proven, safe and time-efficient exercise program.

The purpose of this study is to compare the effects of a low sugar protein pacing, intermittent fasting (P-IF) diet versus a heart healthy (HH) diet on indices of body weight, total and regional body composition, mood state, anti-aging, and cardiometabolic outcomes, and the gut microbiome during weight loss (0-8 weeks). Specifically, this study aims to compare a P-IF diet comprised of a calorie-restricted (1500 calories/day women; 1800 calories/day men) protein pacing diet (P, 4 meals/day women, 5 meals/day men) followed by a fast (IF, ~350-450 kcals/day) compared to an established calorie-restricted (1200 calories/day for women; 1500 calories/day men) heart healthy (HH) diet. The P-IF group will be 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. 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.

Being tested
P-IF, HH
Medical subject headings
Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • P-IFBehavioural

    Protein pacing and intermittent fasting

  • HHBehavioural

    Heart Healthy

Study groups in NCT04327141
Study groupRoleWhat they receive
Protein pacing and intermittent fastingExperimentalDuring 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.
Receives: Behavioral: P-IF
Heart HealthyExperimentalThe 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).
Receives: Behavioral: HH

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in body weight

    Total body weight measurement

    Measured: 0 weeks, 4 weeks, 8 weeks and monthly intervals during the 2 year Case Study

Secondary outcomes (9)

  1. Change in total and regional body fat and lean body mass

    Quantitative measure of total body fat and lean mass using iDXA (dual x-ray absorptiometry)

    Measured: 0 weeks, 8 weeks, 1 year and 2 year of the Case study

  2. Changes in feelings of hunger, fullness, satiety scores measured with a visual analog scale

    Hunger ratings using a visual analog scale ranging from 0-100 mm. A score closer to 0mm indicates no level of hunger related feelings and a score of 100 mm indicates extreme hunger-related feelings

    Measured: 0 weeks, 4 weeks, 8 weeks and monthly intervals during the 2 year Case Study

  3. Change in blood lipid levels

    Venipuncture blood draw of 5ml per visit (weeks 0 and 8) and a single finger stick* of 40ul (week 4); *Finger stick at week 4 will only measure glucose and blood lipids

    Measured: 0 weeks, 4 weeks, 8 weeks and every 6 months during the 2 year Case Study

  4. Change in gut microbiome, gastrointestinal symptoms, stool

    Fecal gut microbiome communities will be sequenced using microbial DNA extracted from samples at 0, 4, and 8 weeks for each study arm. Amplified copies of the 16S rRNA gene will be evaluated for treatment differences in alpha (within-sample richness and evenness) and beta diversity (between-sample community structure). Relative and differential abundance of individual microbial taxa will also be measured. In addition, GI symptoms will be assessed using the Gastrointestinal symptom questionnaire and stool quality will be assessed with the Bristol stool chart

    Measured: 0 weeks, 4 weeks, 8 weeks and two month intervals during the 2 year Case Study

  5. Change in blood pressure

    Quantitative measure of blood pressure using automated blood pressure monitor called a mobiligraph for 1 minute

    Measured: 0 weeks, 4 weeks, 8 weeks and monthly intervals during the 2 year Case Study

  6. Change in heart rate

    Quantitative measure of heart rate using automated heart rate monitor called a mobiligraph for 1 minute

    Measured: 0 weeks, 4 weeks, 8 weeks and monthly intervals during the 2 year Case Study

  7. Change in fat mass and muscle mass

    Quantitative measure of total body fat and muscle mass using BODPod (air displacement plethysmography)

    Measured: 0 weeks, 4 weeks, 8 weeks and monthly intervals during the 2 year Case Study

  8. Change in physical activity

    Quantitative measure of physical activity (kilocalories per day) using the ActiGraph accelerometer

    Measured: 0 weeks, 4 weeks, 8 weeks, and monthly intervals during the 2 year of the Case study

  9. Change in energy intake

    Quantitative measure of energy intake (kilocalories per day) using the 2-day food diary

    Measured: 0 weeks, 4 weeks, 8 weeks, and monthly intervals during the 2 year of the Case study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2020
  2. Study start3 Sep 2020
  3. Primary completion1 Apr 2023
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
40 overweight/obese adult men (n=20) and women (n=20) will be quasi-randomized to one of the two groups matched by sex (men/women) and body weight. 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. A single male participant from the original P-IF group will continue following the identical P-IF from the original 4-8 week phase and 12 month follow up period (5-6 days of P; 1-2 day of IF) for an additional 12 month period (beyond the initial 12 monthfollow up case study period). The participant will consume the identical P-IF meal plan as the original 8 week study and 24 month follow up.
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04327141
Sponsor's protocol ID
1911-859
Status last verified
Apr 2024
First submitted
6 Mar 2020
Last updated
8 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Arciero PJ, Edmonds R, He F, Ward E, Gumpricht E, Mohr A, Ormsbee MJ, Astrup A. Protein-Pacing Caloric-Restriction Enhances Body Composition Similarly in Obese Men and Women during Weight Loss and Sustains Efficacy during Long-Term Weight Maintenance. Nutrients. 2016 Jul 30;8(8):476. doi: 10.3390/nu8080476.

    PubMed 27483317

  • He F, Zuo L, Ward E, Arciero PJ. Serum Polychlorinated Biphenyls Increase and Oxidative Stress Decreases with a Protein-Pacing Caloric Restriction Diet in Obese Men and Women. Int J Environ Res Public Health. 2017 Jan 10;14(1):59. doi: 10.3390/ijerph14010059.

    PubMed 28075418

  • Zuo L, He F, Tinsley GM, Pannell BK, Ward E, Arciero PJ. Comparison of High-Protein, Intermittent Fasting Low-Calorie Diet and Heart Healthy Diet for Vascular Health of the Obese. Front Physiol. 2016 Aug 29;7:350. doi: 10.3389/fphys.2016.00350. eCollection 2016.

    PubMed 27621707

  • Mohr AE, Sweazea KL, Bowes DA, Jasbi P, Whisner CM, Sears DD, Krajmalnik-Brown R, Jin Y, Gu H, Klein-Seetharaman J, Arciero KM, Gumpricht E, Arciero PJ. Gut microbiome remodeling and metabolomic profile improves in response to protein pacing with intermittent fasting versus continuous caloric restriction. Nat Commun. 2024 May 28;15(1):4155. doi: 10.1038/s41467-024-48355-5.

    PubMed 38806467

  • Mohr AE, Jasbi P, Bowes DA, Dirks B, Whisner CM, Arciero KM, Poe M, Gu H, Gumpricht E, Sweazea KL, Arciero PJ. Exploratory analysis of one versus two-day intermittent fasting protocols on the gut microbiome and plasma metabolome in adults with overweight/obesity. Front Nutr. 2022 Oct 26;9:1036080. doi: 10.3389/fnut.2022.1036080. eCollection 2022.

    PubMed 36386914

  • Arciero PJ, Arciero KM, Poe M, Mohr AE, Ives SJ, Arciero A, Boyce M, Zhang J, Haas M, Valdez E, Corbet D, Judd K, Smith A, Furlong O, Wahler M, Gumpricht E. Intermittent fasting two days versus one day per week, matched for total energy intake and expenditure, increases weight loss in overweight/obese men and women. Nutr J. 2022 Jun 4;21(1):36. doi: 10.1186/s12937-022-00790-0.

    PubMed 35658959

Questions about this trial

What is this clinical trial studying?

A study testing P-IF and HH in people with Weight Loss and Gut Microbiome, run by Skidmore College at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in body weight (time frame: 0 weeks, 4 weeks, 8 weeks and monthly intervals during the 2 year Case Study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04327141, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2024.

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