Protein Intake for Obesity

(OPBIM Trial)

Overseen By Principal Investigator, PhD RD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Drexel University

Must not be taking: Anti-seizure, Antidepressants, Antipsychotics

Disqualifiers: Psychiatric, Neurological, Anorexia, Bulimia, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

80 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

If you are taking prescription anti-seizure, antidepressant, or antipsychotic medications, you will need to stop taking them to participate in the trial.

What data supports the effectiveness of the treatment Ensure for obesity?

Research shows that higher-protein diets can help with weight loss and maintaining a healthy weight by improving metabolism and reducing appetite. Studies also indicate that protein-enriched meal replacements, like Ensure, do not negatively impact liver, kidney, or bone health, making them a safe option for weight management. ^{1 2 3 4 5}

Is protein supplementation safe for human consumption?

Research indicates that protein supplements, including those with whey protein and leucine, are generally safe for human consumption. Studies have shown no significant adverse effects on health markers, and they can improve muscle mass and strength, especially in older adults and those on low-calorie diets. ^{3 6 7 8 9}

How does the treatment Ensure differ from other treatments for obesity?

Ensure is unique because it provides a higher-protein diet option, which can help with weight management by improving metabolism and reducing appetite. This approach is different from other treatments that may not focus on protein intake to aid in weight loss and maintenance. ^{1 8 10 11 12}

What is the purpose of this trial?

This study will examine a potential relationship between family history of obesity, that is whether people with at least one parent who had obesity in adulthood compared to people with two parents who did not have obesity in adulthood, and the ability of protein intake to curb further intake of food.

Eligibility Criteria

This trial is for individuals with a family history of obesity, specifically those who have at least one parent who had obesity in adulthood. It aims to understand if protein intake can help control food consumption compared to people whose parents did not have obesity.

Inclusion Criteria

Weight stable for at least 3 months

BMI 20-40

My parents did not have obesity in adulthood, or one of them did.

Exclusion Criteria

I do not have any neurological disorders.

No current diagnosis or history of anorexia nervosa

Not currently breastfeeding

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preload Testing

Participants receive two different preloads on separate days to assess the effect on food intake and brain activation

2 days

2 visits (in-person)

Brain Imaging and Food Consumption

Functional near infra-red spectroscopy (fNIR) is used to measure brain activation during food consumption, specifically pizza, to assess the satiation response to protein

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any delayed effects of the preloads and brain imaging

4 weeks

Treatment Details

Interventions

• Ensure

Trial Overview The study is testing the effects of consuming Ensure (a nutritional drink) versus water on food intake and brain responses related to appetite and satiety in participants with different family histories of obesity.

Participant Groups

Group I: Preloads Experimental Treatment 1 Intervention

Delivery of two different preloads to all participants, each preload tested on a separate day/participant, prior to consumption of pizza

Ensure is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Ensure for:

• Nutritional deficiency
• Weight loss
• Recovering from illness or surgery
• Low residue diets
• Occasional meal replacement
• Between meal snack

Approved in European Union as Ensure for:

• Nutritional deficiency
• Weight loss
• Recovering from illness or surgery
• Low residue diets
• Occasional meal replacement
• Between meal snack

Approved in Canada as Ensure for:

• Nutritional deficiency
• Weight loss
• Recovering from illness or surgery
• Low residue diets
• Occasional meal replacement
• Between meal snack

Who Is Running the Clinical Trial?

Drexel University

Lead Sponsor

Trials

160

Recruited

48,600+

Findings from Research

Higher-protein diets (1.2 to 1.6 g protein per kg of body weight per day) have been shown to lead to greater weight loss, fat mass loss, and preservation of lean mass compared to lower-protein diets, based on several meta-analyses of short-term studies.

While short-term studies consistently show benefits of higher protein intake, longer-term studies yield mixed results, primarily due to dietary compliance; those who adhered to higher-protein diets experienced significant improvements in body weight and cardiometabolic risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of protein in weight loss and maintenance. Leidy, HJ., Clifton, PM., Astrup, A., et al.[2023]

In a study involving 100 obese participants over 30 years old, both high protein (HP) and standard protein (SP) meal replacements led to similar weight loss outcomes after one year, indicating that protein-enriched meal replacements are effective for weight management.

Importantly, the study found no adverse effects on liver function, renal function, or bone density after one year of using protein-enriched meal replacements, suggesting they are safe for long-term use in weight management programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protein-enriched meal replacements do not adversely affect liver, kidney or bone density: an outpatient randomized controlled trial. Li, Z., Treyzon, L., Chen, S., et al.[2021]

In an 8-week study with 12 elderly participants, a meal replacement formula containing essential amino acids (EAAMR) led to a greater reduction in adipose tissue compared to a competitive meal replacement, despite both groups losing about 7% of their total body weight.

While EAAMR did not significantly preserve lean tissue, it was associated with an increase in the skeletal muscle fractional synthesis rate (FSR), suggesting that it may help maintain muscle protein turnover during caloric restriction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whey protein and essential amino acids promote the reduction of adipose tissue and increased muscle protein synthesis during caloric restriction-induced weight loss in elderly, obese individuals. Coker, RH., Miller, S., Schutzler, S., et al.[2022]

In a study involving 84 hospitalized patients at nutritional risk, a novel protein-supplemented food service significantly increased the percentage of patients meeting their protein requirements (66% in the intervention group vs. 30% in the control group).

The intervention group also had a higher mean intake of energy and protein per body weight compared to the control group, indicating that the protein-supplemented food service effectively improved nutritional intake in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive effect of protein-supplemented hospital food on protein intake in patients at nutritional risk: a randomised controlled trial. Munk, T., Beck, AM., Holst, M., et al.[2014]

In a study of 107 women with normal-weight obesity, replacing snacks with soy-enriched high protein options for six months significantly reduced appetite and body fat percentage, while also increasing skeletal muscle mass.

The high protein snack group experienced a notable decrease in energy intake and waist circumference compared to the low protein snack group, indicating that soy-enriched high protein snacks can effectively improve body composition in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of 6 Months of Soy-Enriched High Protein Compared to Eucaloric Low Protein Snack Replacement on Appetite, Dietary Intake, and Body Composition in Normal-Weight Obese Women: A Randomized Controlled Trial. Haghighat, N., Ashtary-Larky, D., Bagheri, R., et al.[2021]

Supplementing breakfast with a vitamin D and leucine-enriched whey protein drink significantly increased postprandial muscle protein synthesis in healthy older adults, indicating a beneficial effect on muscle anabolism.

After 6 weeks, participants who consumed the protein drink gained more appendicular lean mass compared to the control group, suggesting that this intervention can help preserve and build muscle mass in older individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supplementing Breakfast with a Vitamin D and Leucine-Enriched Whey Protein Medical Nutrition Drink Enhances Postprandial Muscle Protein Synthesis and Muscle Mass in Healthy Older Men. Chanet, A., Verlaan, S., Salles, J., et al.[2023]

In a double-blind, placebo-controlled trial with 60 healthy adults over 90 days, protein supplements significantly improved quality of life by 85.76%, VO2 max by 42.92%, and reduced body weight by 1.94 kg, indicating their efficacy in promoting health and well-being.

The study found no clinically significant changes in vital signs or blood parameters, demonstrating that protein supplements are safe for consumption without adverse effects on gut health or overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety assessment of protein supplement - micronutrient fortification in promoting health and wellbeing in healthy adults - a randomized placebo-controlled trial. Ambulkar, P., Hande, P., Tambe, B., et al.[2023]

A short-term low-calorie diet combined with whey protein and leucine supplementation led to significant weight loss and improved muscle strength in 16 post-menopausal women with sarcopenic obesity over 45 days.

Participants preserved their lean body mass while experiencing reductions in BMI, waist circumference, and fasting insulin levels, indicating that this dietary approach can effectively manage obesity without compromising muscle health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whey Protein, L-Leucine and Vitamin D Supplementation for Preserving Lean Mass during a Low-Calorie Diet in Sarcopenic Obese Women. Camajani, E., Persichetti, A., Watanabe, M., et al.[2022]

In a study of 49 healthy older men, consuming a protein-based nutritional supplement twice daily for 20 weeks significantly increased muscle strength and lean mass compared to a control group, with notable gains in strength during the initial 6 weeks without exercise.

The benefits of the supplement were further enhanced when combined with exercise, leading to greater upper body strength at the end of the study, demonstrating its efficacy in promoting muscle health in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A whey protein-based multi-ingredient nutritional supplement stimulates gains in lean body mass and strength in healthy older men: A randomized controlled trial. Bell, KE., Snijders, T., Zulyniak, M., et al.[2022]

In a 12-week pilot study involving 28 older adults, whey protein was found to be a feasible and acceptable supplement during a weight-loss intervention, with high compliance rates among participants.

While both groups lost weight, those consuming whey protein showed a significant improvement in grip strength compared to the non-protein group, suggesting that whey protein may help preserve muscle function during weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of whey protein supplementation in a weight-loss intervention in rural dwelling adults: A feasibility study. Batsis, JA., Petersen, CL., Cook, SB., et al.[2022]

In a study involving 90 patients with obesity, the protein and vitamin-enriched preparation 'Miprovit' significantly reduced serum cholesterol and glucose levels, as well as the atherogenic coefficient.

75% of the patients reported decreased appetite and hunger, indicating that 'Miprovit' not only aids in weight reduction but also improves overall comfort during the treatment process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Experience in using the biologically active additive "miprovit" in the treatment of various metabolic diseases]. Popova, IuP., Grigor'ian, ON., Oleneva, VA., et al.[2013]

In a 10-week study involving 25 male endurance athletes, those who consumed a protein blend (beef and whey) with orange juice significantly reduced body fat and increased lower body lean mass compared to those who consumed carbohydrates alone.

Despite the positive changes in body composition, both groups showed similar improvements in performance, indicating that the protein blend did not provide additional benefits for endurance performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intake of Animal Protein Blend Plus Carbohydrate Improves Body Composition With no Impact on Performance in Endurance Athletes. Naclerio, F., Larumbe-Zabala, E., Larrosa, M., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

The role of protein in weight loss and maintenance. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Protein-enriched meal replacements do not adversely affect liver, kidney or bone density: an outpatient randomized controlled trial. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Whey protein and essential amino acids promote the reduction of adipose tissue and increased muscle protein synthesis during caloric restriction-induced weight loss in elderly, obese individuals. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Positive effect of protein-supplemented hospital food on protein intake in patients at nutritional risk: a randomised controlled trial. [2014]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of 6 Months of Soy-Enriched High Protein Compared to Eucaloric Low Protein Snack Replacement on Appetite, Dietary Intake, and Body Composition in Normal-Weight Obese Women: A Randomized Controlled Trial. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Supplementing Breakfast with a Vitamin D and Leucine-Enriched Whey Protein Medical Nutrition Drink Enhances Postprandial Muscle Protein Synthesis and Muscle Mass in Healthy Older Men. [2023]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

Efficacy and safety assessment of protein supplement - micronutrient fortification in promoting health and wellbeing in healthy adults - a randomized placebo-controlled trial. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Whey Protein, L-Leucine and Vitamin D Supplementation for Preserving Lean Mass during a Low-Calorie Diet in Sarcopenic Obese Women. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

A whey protein-based multi-ingredient nutritional supplement stimulates gains in lean body mass and strength in healthy older men: A randomized controlled trial. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Impact of whey protein supplementation in a weight-loss intervention in rural dwelling adults: A feasibility study. [2022]

11. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Experience in using the biologically active additive "miprovit" in the treatment of various metabolic diseases]. [2013]

12. United States pubmed.ncbi.nlm.nih.gov

Intake of Animal Protein Blend Plus Carbohydrate Improves Body Composition With no Impact on Performance in Endurance Athletes. [2019]