Scientific deep-dive

Does Lumen Help With Weight Loss? No Controlled Trial Says So

No controlled trial shows the Lumen breath device helps weight loss. Its CO2 reading tracked a lab metabolic cart loosely in two small company-linked studies, and FDA's databases list no clearance. What it measures and what indirect calorimetry measures instead.

By Ruth Calder · Enforcement Editor
Editorially reviewed. Not medical advice · How we verify contentLast reviewed
10 min read·22 citations

Part of Weight-loss gadgets and wellness trends

No controlled trial has shown that Lumen helps people lose weight. The handheld device reads the carbon dioxide in one held breath and turns it into a 1-to-5 score for whether you are burning more carbohydrate or more fat.[2] Two small studies found that the reading rises after a sugary meal, as lab gas measurements do, but it tracked them loosely, explaining about a fifth of the variation in the lab result.[1][2] The only weight-loss study had no comparison group and put everyone on a 500-calorie daily deficit, so it cannot separate the device from the diet.[3] Every published Lumen study had company employees or advisers among its authors. FDA’s clearance and approval databases list no Lumen device,[15][16][17] and the company’s own terms call it a wellness product that does not diagnose or treat any condition.[21]

About this article. Study findings come from the published papers on PubMed, read in full where free text exists. Trial registrations come from ClinicalTrials.gov, and regulatory status from FDA’s device databases and its January 2026 general wellness guidance. Lumen is made by Metaflow Ltd of Tel Aviv. This page names the product so readers can find it; it does not sell it, and we hold no relationship with the company.

What Lumen measures

Your body burns a mix of fat and carbohydrate. The two fuels use oxygen and give off carbon dioxide in different proportions. Burning pure fat produces about 0.7 molecules of carbon dioxide for every molecule of oxygen used; burning pure carbohydrate produces about 1.0. That ratio is the respiratory exchange ratio, or RER, and it sits somewhere between those two numbers depending on what you have eaten and what you are doing.[2]

Lumen does not measure oxygen. The user breathes in through the device, holds the breath for 10 seconds, then breathes out through it, three times per session.[1] The device reads the share of carbon dioxide in that exhaled breath and the flow rate, and the app converts the result into a Lumen score from 1 to 5. The score is scaled to each user’s own range of past readings: 1 stands for the lowest assumed RER (more fat burning) and 5 for the highest (more carbohydrate burning).[2] So the score is an estimate of an estimate. It infers RER from carbon dioxide alone, then ranks it against your own history.

The company frames this as tracking “metabolic flexibility,” a real research term for how readily the body switches between fuels as conditions change.[9] In labs it is measured with indirect calorimetry: a metabolic cart or a sealed room that captures both the oxygen a person uses and the carbon dioxide they produce, usually before and after a standard glucose load or a change in diet.[7][11] The same oxygen and carbon dioxide figures also give calories burned, through an equation first published in 1949.[8] Lumen gives neither a measured RER nor a calorie figure.

How well Lumen matches a metabolic cart

Two peer-reviewed studies compared Lumen with laboratory gas analysis.

Studies comparing Lumen with laboratory measurement
StudyWhoWhat was comparedResultCompany role
Lorenz 2021[1]33 healthy adults, mean age 23Lumen CO2 vs metabolic-cart RER, fasting and after 150 g of glucoseBoth rose after glucose; Lumen explained about 23% of the variation in RER (R² 0.23)Two Metaflow employees co-designed and analyzed the study
Roberts 2023, lab phase[2]12 healthy adultsLumen CO2 vs Douglas-bag RER after a high-carbohydrate mealBoth rose within 30 minutes; Lumen explained about 20% of the variation (R² 0.20)Two MetaFlow employees on design and equipment; one author a company adviser
Roberts 2023, diet phase[2]27 active adults, crossoverLumen readings during 7 days of low-carb vs 7 days of high-carb eatingReadings were lower on low-carb at every time point (fasted 4.35% vs 4.46% CO2)As above

These studies show that the device moves in the expected direction when someone swallows a large dose of sugar, and that its average readings differ after a week of very different diets. That is a group-level signal. They do not show that a single morning reading tells one person how much fat they are burning. An R² near 0.2 means about four-fifths of the variation in the lab measure was not captured by the device. Neither study tested people with obesity, diabetes, older adults, or anyone on a weight-loss drug; the authors of the first study flagged that their participants were young and healthy.[1] The second study’s authors called for more work in applied settings.[2]

There is a simpler problem too. A carbohydrate meal raises carbon dioxide output, and a low-carbohydrate diet lowers it. A device that reports this back to you mostly confirms what you ate. The company’s largest analysis, of 707,372 morning readings from 48,058 users, found that the previous day’s reported carbohydrate intake was the strongest predictor of the next morning’s reading, with an effect size the authors themselves reported as a Cohen’s d of 0.07 in women and 0.05 in men.[5] Effects that small are detectable in a dataset that large and are hard to read in one person on one morning.

Does Lumen help weight loss?

No controlled trial has tested it. The one published intervention study enrolled 30 adults with prediabetes in Tel Aviv, of whom 27 finished 12 weeks. Each took a daily morning reading and received meal guidance from the app, along with remote support from a Lumen coach. Average weight fell by 5.99 kg, HbA1c by 0.27 percentage points, and waist size by 6.2 cm.[3]

Three features of that study keep it from answering the question. First, there was no control group, which the authors acknowledged: they could not compare the result with “other traditional nutrition and coaching interventions.” Second, every participant was told to eat 500 calories a day fewer than their estimated needs, with coaching on top. A daily 500-calorie deficit and a coach produce weight loss without any breath device. Third, four of the ten authors were Metaflow employees who helped design and analyze it.[3] The study shows that people on a coached 500-calorie deficit lost weight. It does not show that the breath reading added anything.

ClinicalTrials.gov lists one randomized trial with Lumen as the intervention: a study at Rambam Health Care Campus comparing Lumen with a glucose-tracking app in gestational diabetes, with blood glucose as the main outcome, not weight. Its status is listed as unknown and it has posted no results.[19] A Technical University of Munich study with Metaflow as a collaborator randomized 30 people to different diets and used breath carbon dioxide as an outcome. It finished in April 2024 and has posted no results; it tested the diets, not the device.[20] The prediabetes pilot’s registration is also still marked unknown.[18]

The published Lumen research, by type
Type of studyStudiesCan it show the device causes weight loss?
Lab comparison with RERLorenz 2021; Roberts 2023[1][2]No. Measures agreement, not outcomes
Single-arm diet programBuch 2023, 27 completers[3]No. No control group; 500-calorie deficit for all
Analyses of users’ app dataYeshurun 2024 and 2025; Cramer 2024[4][5][6]No. Observational, self-selected users, company authors
Randomized trial of the deviceNone published; one registered, in gestational diabetes[19]Not yet tested for weight

What the user-data studies say

Metaflow staff have published three analyses of readings uploaded by paying users. In 2,607 users who logged meals, readings rose more after higher-carbohydrate meals, and rose less in users with a higher BMI, which the authors read as reduced metabolic flexibility in obesity.[4] In the 48,058-user analysis, morning readings tracked the previous day’s carbohydrates and fell with longer overnight fasts.[5] A third paper described readings that cycle with the menstrual cycle and differ in menopausal women on and off hormone therapy.[6]

These are descriptions of what the device records, not tests of whether using it helps. The users chose to buy the device and chose which meals to log, and the authors on all three papers were Metaflow employees, consultants or founders. The menstrual-cycle finding matters for a different reason: if hormones shift the reading, a woman’s score can move for reasons that have nothing to do with diet.

Does metabolic flexibility matter for weight?

The idea behind Lumen comes from real research. In a 1990 study of 152 adults whose 24-hour fuel use was measured in a sealed calorimetry room, those whose bodies leaned toward carbohydrate burning were 2.5 times as likely to gain 5 kg or more over the following two years or so as those who leaned toward fat.[10] A 2020 NIH study of 79 adults found that people who shifted less toward fat burning during a day of high-fat overfeeding gained more weight over the following year.[11]

Those findings came from whole-room calorimeters, which measure every breath for 24 hours under controlled meals. They identify who may be prone to weight gain. They do not show that tracking your fuel mix at home and adjusting your carbohydrates in response produces weight loss. The closest large test of matching diet to metabolism points the other way. In the DIETFITS trial, 609 adults were randomized to a healthy low-fat or healthy low-carbohydrate diet for a year. Weight loss was nearly identical, 5.3 kg against 6.0 kg, and the baseline insulin response that was supposed to predict who would do better on which diet did not.[12] Whether lab-measured metabolic flexibility can predict who will succeed with a given lifestyle program is still being studied, with first data expected in 2026.[22] For other diet rules that have outrun their evidence, see the diet advice nobody has tested.

Lumen and GLP-1 drugs

No study has tested Lumen in people taking semaglutide, tirzepatide or any other weight-loss drug. The drugs do change fuel use. In a placebo-controlled trial using whole-room calorimetry, tirzepatide increased fat burning alongside the drop in appetite and calories eaten.[13] But someone on a GLP-1 drug is usually eating far less, and often less carbohydrate, which by itself would push a breath reading toward the fat-burning end. A lower Lumen score on the drug would mostly reflect smaller meals. It would not tell you whether the dose is working, whether you are losing fat or muscle, or whether your metabolism has slowed. For what the calorimetry studies show about metabolic rate on these drugs, see does Ozempic slow your metabolism.

A breath score also does not replace the measures that matter on treatment: weight, waist size, and the protein and food intake that protect lean mass. Our calorie deficit calculator estimates daily needs from standard equations, and intermittent fasting on a GLP-1 covers what has been tested about meal timing on these drugs.

Is Lumen FDA approved or cleared?

No. A search of FDA’s 510(k), De Novo and premarket approval databases in October 2026 returned no device from Metaflow and no Lumen breath device.[15][16][17] Lumen’s own terms of use describe the service as “provided solely as a wellness product for metabolic measurement, reading and tracking” and say it is not intended to diagnose, treat, cure, mitigate or prevent any disease or medical condition.[21]

FDA’s general wellness guidance, reissued in January 2026, explains why that matters. Low-risk, non-invasive products whose claims stay on general topics such as weight management fall outside FDA’s active device oversight. The guidance lists “assist with weight loss goals” as an acceptable wellness claim, and a claim to “treat or diagnose obesity” as one that is not.[14] The guidance is just as clear about what wellness status does not mean:

“A product’s inclusion under the general wellness policy in this guidance does not establish that it has been shown to be safe and/or effective for its intended use.”
— FDA, General Wellness: Policy for Low Risk Devices, January 2026

FDA does not publish a list of products it considers wellness devices, so nothing here says FDA has reviewed Lumen. No FDA review of its accuracy or benefit appears in the public record. Glucose sensors marketed for weight loss raise a similar question about whether a number on a phone changes outcomes; CGM for weight loss without diabetes covers what the trials show for them.

What established measures exist

If you want to know how many calories you burn at rest, the established test is indirect calorimetry, which measures both oxygen and carbon dioxide and is considered the reference method for energy expenditure.[7] It is used in hospital nutrition care to set calorie targets, and some clinics and sports labs offer a resting test.[7] It gives a resting metabolic rate in calories and a measured RER. It is still one snapshot, and for most people trying to lose weight it changes little: the practical levers are the same whatever the number says.

Lumen compared with lab indirect calorimetry
LumenIndirect calorimetry
Gases measuredCarbon dioxide only, after a breath hold[1]Oxygen and carbon dioxide[7]
Output1–5 score scaled to your own past readings[2]Measured RER and calories burned[8]
Agreement with lab RERR² about 0.2 in two small studies[1][2]The reference method
Shown to improve weight loss?No controlled trialNot tested as a weight-loss tool either
FDA statusNo clearance or approval listed[15][16][17]Lab and clinical equipment

Lumen detects, on average, that you ate carbohydrate. It has not been shown to measure an individual’s fat burning precisely, and it has not been shown to help anyone lose more weight than the diet and coaching that come with it.

Frequently Asked Questions

No controlled trial has shown it. The only weight-loss study had 27 completers, no comparison group, and put everyone on a coached 500-calorie daily deficit, so the 6 kg average loss cannot be credited to the device. Company employees co-designed and analyzed it.
The share of carbon dioxide in one held breath, plus breath flow. The app turns this into a 1-to-5 score meant to show whether you are burning more carbohydrate or more fat, scaled to your own past readings. It does not measure oxygen or calories.
On average, its reading rises after a high-carbohydrate meal, as lab gas measurements do. In two small studies it explained only about 20% to 23% of the variation in the lab measurement, both studies had company-linked authors, and neither tested people with obesity or diabetes.
No. FDA's 510(k), De Novo and premarket approval databases list no Lumen breath device or Metaflow application as of October 2026. The company describes it as a wellness product that does not diagnose or treat any condition, and FDA says wellness status does not establish safety or effectiveness.
No study has tested Lumen in people on GLP-1 drugs. Eating less, and less carbohydrate, would lower the reading on its own. Weight, waist size and how you feel on the dose are better signs than a breath score.
Indirect calorimetry, which measures both oxygen and carbon dioxide, is the reference method for calories burned and fuel use. Some clinics and sports labs offer a resting test. For most people losing weight, it changes little about what to do next.

References

  1. 1.Lorenz KA, Yeshurun S, Aziz R, Ortiz-Delatorre J, Bagley JR, Mor M, Kern M A Handheld Metabolic Device (Lumen) to Measure Fuel Utilization in Healthy Young Adults: Device Validation Study Interact J Med Res. 2021. PMID: 33870899.
  2. 2.Roberts J, Dugdale-Duwell D, Lillis J, et al. The efficacy of a home-use metabolic device (Lumen) in response to a short-term low and high carbohydrate diet in healthy volunteers J Int Soc Sports Nutr. 2023. PMID: 36862060.
  3. 3.Buch A, Yeshurun S, Cramer T, et al. The Effects of Metabolism Tracker Device (Lumen) Usage on Metabolic Control in Adults with Prediabetes: Pilot Clinical Trial Obes Facts. 2023. PMID: 36195053.
  4. 4.Yeshurun S, Cramer T, Souroujon D, Mor M The Association of Macronutrient Consumption and BMI to Exhaled Carbon Dioxide in Lumen Users: Retrospective Real-World Study JMIR Mhealth Uhealth. 2024. PMID: 38439744.
  5. 5.Yeshurun S, Cramer T, Souroujon D, Mor M The Association of Previous Day Carbohydrate Consumption With Fasted, Exhaled Carbon Dioxide in Lumen Users: Retrospective Real-World Study JMIR Mhealth Uhealth. 2025. PMID: 40772962.
  6. 6.Cramer T, Yeshurun S, Mor M Changes in Exhaled Carbon Dioxide during the Menstrual Cycle and Menopause Digit Biomark. 2024. PMID: 39015514.
  7. 7.Delsoglio M, Achamrah N, Berger MM, Pichard C Indirect Calorimetry in Clinical Practice J Clin Med. 2019. PMID: 31491883.
  8. 8.Weir JB New methods for calculating metabolic rate with special reference to protein metabolism J Physiol. 1949. PMID: 15394301.
  9. 9.Goodpaster BH, Sparks LM Metabolic Flexibility in Health and Disease Cell Metab. 2017. PMID: 28467922.
  10. 10.Zurlo F, Lillioja S, Esposito-Del Puente A, et al. Low ratio of fat to carbohydrate oxidation as predictor of weight gain: study of 24-h RQ Am J Physiol. 1990. PMID: 2240203.
  11. 11.Begaye B, Vinales KL, Hollstein T, et al. Impaired Metabolic Flexibility to High-Fat Overfeeding Predicts Future Weight Gain in Healthy Adults Diabetes. 2020. PMID: 31712321.
  12. 12.Gardner CD, Trepanowski JF, Del Gobbo LC, et al. Effect of Low-Fat vs Low-Carbohydrate Diet on 12-Month Weight Loss in Overweight Adults and the Association With Genotype Pattern or Insulin Secretion: The DIETFITS Randomized Clinical Trial JAMA. 2018. PMID: 29466592.
  13. 13.Ravussin E, Sanchez-Delgado G, Martin CK, et al. Tirzepatide did not impact metabolic adaptation in people with obesity, but increased fat oxidation Cell Metab. 2025. PMID: 40203836.
  14. 14.U.S. Food and Drug Administration General Wellness: Policy for Low Risk Devices. Guidance for Industry and Food and Drug Administration Staff (January 6, 2026) FDA. 2026. https://www.fda.gov/media/90652/download
  15. 15.U.S. Food and Drug Administration Premarket Notification 510(k) database (searched for Metaflow and Lumen, October 2026) FDA. 2026. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm
  16. 16.U.S. Food and Drug Administration Device Classification Under Section 513(f)(2) (De Novo) database (searched for Metaflow, October 2026) FDA. 2026. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm
  17. 17.U.S. Food and Drug Administration Premarket Approval (PMA) database (searched for Metaflow and Lumen, October 2026) FDA. 2026. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm
  18. 18.Tel-Aviv Sourasky Medical Center; Metaflow Ltd. Using the Lumen Device for Prediabetes Prevention (NCT04555421) ClinicalTrials.gov. 2020. https://clinicaltrials.gov/study/NCT04555421
  19. 19.Rambam Health Care Campus A Novel Device for Gestational Diabetes Control, a Randomized Control Trial (NCT05812547) ClinicalTrials.gov. 2023. https://clinicaltrials.gov/study/NCT05812547
  20. 20.Technical University of Munich; Metaflow Ltd. Indices of Metabolic Flexibility and Ketone Production During Short-Term Energy Deficit With and Without Dietary Carbohydrate Restriction (NCT07429058) ClinicalTrials.gov. 2026. https://clinicaltrials.gov/study/NCT07429058
  21. 21.Metaflow Ltd. Lumen Terms of Use, sections 2.6 and 11 (company website, read October 2026) Lumen. 2026.
  22. 22.Ludlova M, Koudelková K, Pallova J, et al. Metabolic Flexibility to Predict Lifestyle Interventions Outcomes (MEPHISTO): Protocol for Predictive Validation Study and Randomized Controlled Trial JMIR Res Protoc. 2025. PMID: 40340957.

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